Publications by authors named "Rossella E Nappi"

148 Publications

Insulin resistance and potential modulators of ovarian reserve in young reproductive-aged women with obesity and type 1 diabetes.

Gynecol Endocrinol 2021 Jun 17:1-8. Epub 2021 Jun 17.

Department of Pediatrics, "Vittore Buzzi" Children's Hospital, Milano, Italy.

Introduction: Both obesity and diabetes play a significant role in reproductive disorders in women and insulin resistance (IR) is a confirmed . We evaluated the relationship between IR and an established ovarian reserve biomarker such as anti-mullerian hormone (AMH) together with other potential modulators of ovarian physiology (adiponectin and kisspeptin) in young reproductive-aged group women with obesity and type 1 diabetes (T1D).

Patients And Methods: We recruited 32 female youths: 14 of them presented with T1D (14.6 ± 2.6 years) and 18 with obesity (15.1 ± 2.6 years). The control group included 20 age-matched normal weight females. Each patient underwent physical examination and hormonal assessment. AMH, kisspeptin and adiponectin levels were also measured. IR was calculated as the homeostasis model assessment for insulin resistance (HOMA-IR) and the glucose disposal rate (eGDR) in patients with obesity and with T1D, respectively.

Results: adiponectin and kisspeptin levels were significantly different into groups ( ≤ .001), whereas AMH levels were not. Adiponectin values were higher in controls compared to patients with obesity ( < .001) and T1D ( = .02). Kisspeptin levels were lower in controls compared to patients with obesity ( = .001), without reaching statistical significance when compared to T1D ( = .06). IR was associated with lower adiponectin and higher kisspeptin levels ( < .001 and  = .02, respectively), but not with AMH.

Conclusions: IR displays a relationship with adiponectin and kisspeptin in young reproductive-aged women with obesity and T1D. Interventions to correct IR in adolescents could be part of an early approach to prevent reproductive disorders and to promote factors associated with longevity in adult women.
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http://dx.doi.org/10.1080/09513590.2021.1940127DOI Listing
June 2021

Treatment of vulvo-vaginal atrophy with hyaluronate-based gel: a randomized controlled study.

Minerva Obstet Gynecol 2021 Jun 7. Epub 2021 Jun 7.

Fidia Farmaceutici, S.p.A., Abano Terme, Padua, Italy.

Background: The study aimed to assess the performance and safety of single-use applicators prefilled with hyaluronic acid (HA)-based vaginal gel (Hyalo Gyn) for the treatment of vulvovaginal atrophy (VVA)-related signs and symptoms in postmenopausal women.

Methods: Eighty women were randomized, 46 to Hyalo Gyn gel and 34 to a standard treatment (water-based lubricant). Outcome data collected included: the proportion of subjects having a reduction ≥1 point in the Verbal Rating Scale (VRS) dryness score, VRS global score, vaginal pH, Vaginal Health Index (VHI), Female Sexual Function Index (FSFI), Female Sexual Distress Scale-Revised (FSDS-R), patients' global assessment, tolerability, and safety.

Results: Significant improvements were observed for all the assessed endpoints in both treatment groups. The perception of any improvement on the VRS dryness score was not statistically different between the treatment groups. A sensitivity analysis on the absolute change in VRS dryness score showed a statistically significant difference in favor of the Hyalo Gyn group at 3 months.

Conclusions: A 3-month treatment with Hyalo Gyn gel is effective, safe, and well tolerated for VVA-related symptoms in post-menopausal women.
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http://dx.doi.org/10.23736/S2724-606X.21.04841-7DOI Listing
June 2021

Global cross-sectional survey of women with vasomotor symptoms associated with menopause: prevalence and quality of life burden.

Menopause 2021 May 24. Epub 2021 May 24.

Research Center for Reproductive Medicine, Gynecological Endocrinology and Menopause, IRCCS San Matteo Foundation, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy Seattle Women's: Health, Research, Gynecology, Seattle, WA Astellas Pharma, Chertsey, UK (At time of research) Astellas Pharma, Chertsey, UK IQVIA, London, UK IQVIA, Real World Solutions, Falls Church, VA Astellas Pharma, Northbrook, IL.

Objective: To determine prevalence and health-related quality of life (HRQOL) of moderate-to-severe vasomotor symptoms (VMS) in postmenopausal women in Europe, the US, and Japan, and among subgroups of women not taking hormone therapy (HT).

Methods: Screening surveys were sent to a random sample of women aged 40 to 65 years; full questionnaires followed to those who completed them and met inclusion criteria. Women with successfully treated VMS, breast cancer, or on HT for medical conditions were excluded. The Menopause-Specific QOL (MENQOL) and Work Productivity and Activity Impairment (WPAI) questionnaires were included in the questionnaire.

Results: Of 25,161 women completing the screening survey, 11,771 were postmenopausal and 3,460 met inclusion criteria and completed the full questionnaire. Prevalence of moderate-to-severe VMS was 40%, 34%, and 16% in Europe, the US, and Japan, respectively. A large proportion were HT averse, albeit eligible (Europe 56%, US 54%, Japan 79%). In total, 12%, 9%, and 8% in Europe, the US, and Japan, respectively, were HT-contraindicated. A high proportion were HT-cautious (Europe 70%, US 69%, Japan 52%). Most common menopausal symptoms reported in the MENQOL were feeling tired or worn out (Europe/US 74%, Japan 75%), aching in muscles and joints (Europe 69%, US 68%, Japan 61%), difficulty sleeping (Europe 69%, US 66%, Japan 60%), and hot flashes (Europe 67%, US 68%, Japan 62%). Overall, the most bothersome symptom was weight gain. As measured by the WPAI, hot flashes and night sweats had a greater impact on daily activities than on working activities.

Conclusions: A high proportion of women experienced moderate-to-severe VMS, with associated symptoms impacting QOL.
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http://dx.doi.org/10.1097/GME.0000000000001793DOI Listing
May 2021

A core outcome set for genitourinary symptoms associated with menopause: the COMMA (Core Outcomes in Menopause) global initiative.

Menopause 2021 May 10. Epub 2021 May 10.

Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Australia Women's Health Research Program, School of Public Health and Preventive Medicine, Monash University. Melbourne, Australia School of Nursing, Indiana University, Indianapolis, IN Department of Obstetrics and Gynaecology, University of Chicago, Chicago, IL Red Hot Mamas North America, Inc., New York, NY Department of Obstetrics and Gynecology, New York University School of Medicine, New York, NY Department of Obstetrics and Gynaecology, University Hospitals Dorset NHS Trust, Poole, Dorset, UK Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK Centre for Women's Health, Institute of Population Health Sciences, Queen Mary University London, UK Department of Obstetrics and Gynaecology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand Department of Obstetrics and Gynaecology, Fortis Escort Hospital, Jaipur, India Department of Gynaecology and Obstetrics, University of Muenster, Muenster, Germany Adelaide Medical School, Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, Australia Department of Reproductive and Maternal Medicine, School of Medicine, University of Glasgow, Glasgow, UK Departments of Psychiatry, Psychology and Obstetrics and Gynecology, University of Illinois at Chicago, Chicago IL Vincent Center for Reproductive Biology, Massachusetts General Hospital, Boston, MA Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, Research Center for Reproductive Medicine, Gynecological Endocrinology and Menopause, IRCCS San Matteo Foundation, University of Pavia, Pavia, Italy Department of Urology, UIC College of Medicine, Chicago IL Queen Charlotte's and Chelsea and Westminster Hospitals, Imperial College London, London, UK Auckland District Health Board, Auckland, New Zealand Department of Obstetrics and Gynecology, Midlife Women's Health Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA Department of Obstetrics and Gynecology, George Washington University, Washington, DC Department of Obstetrics and Gynecology, University Clinic Inselspital Bern, Bern, Switzerland Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, Clayton, Victoria, Australia Department of Obstetrics and Gynaecology, University of Toronto, Toronto, Canada.

Objective: Genitourinary symptoms, such as vaginal dryness and pain with sex, are commonly experienced by postmenopausal women. Comparing treatments for these genitourinary symptoms are restricted by the use of different outcome measures in clinical trials and the omission of outcomes, which may be relevant to women. The aim of this project was to develop a Core Outcome Set (COS) to be reported in clinical trials of treatments for genitourinary symptoms associated with menopause.

Methods: We performed a systematic review of randomized controlled trials of treatments for genitourinary symptoms associated with menopause and extracted their outcomes. This list was refined and entered into a two-round modified Delphi survey, which was open to clinicians, researchers, and postmenopausal women from November 2019 to March 2020. Outcomes were scored on a nine-point scale from "not important" to "critically important." The final COS was determined following two international consensus meetings.

Results: A total of 26 unique outcomes were included in the Delphi process, which was completed by 227 participants of whom 58% were postmenopausal women, 34% clinicians, and 8% researchers. Predefined thresholds were applied to the Delphi scores to categorize outcomes by importance, which informed the e consensus meetings, attended by 43 participants from 21 countries. The final COS includes eight outcomes: (1) pain with sex, (2) vulvovaginal dryness, (3) vulvovaginal discomfort or irritation, (4) discomfort or pain when urinating, (5) change in most bothersome symptom, (6) distress, bother or interference of genitourinary symptoms, (7) satisfaction with treatment, (8) side effects of treatment.

Conclusion: These eight core outcomes reflect the joint priorities of postmenopausal women, clinicians, and researchers internationally. Standardized collection and reporting of these outcomes in clinical trials will facilitate the comparison of different treatments for genitourinary symptoms, advance clinical practice, and ultimately improve outcomes for symptomatic women.

Video Summary:http://links.lww.com/MENO/A765.
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http://dx.doi.org/10.1097/GME.0000000000001788DOI Listing
May 2021

Clinical features of migraine with onset prior to or during start of combined hormonal contraception: a prospective cohort study.

Acta Neurol Belg 2021 Apr 29. Epub 2021 Apr 29.

Department of Neurology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.

Many studies have described the features of menstrually related migraines but there is a lack of knowledge regarding the features of migraine in combined hormonal contraceptive users (CHC). Hormone-withdrawal migraines in the pill-free period could differ from those in the natural cycle. Gynaecologic comorbidities, like dysmenorrhea and endometriosis, but also depression or a family history might modify the course of migraine. A better understanding of migraine features linked to special hormonal situations could improve treatment. For this prospective cohort study, we conducted telephone interviews with women using a CHC and reporting withdrawal migraine to collect information on migraine frequency, intensity, triggers, symptoms, pain medication, gynaecologic history and comorbidities (n = 48). A subset of women agreed to also document their migraines in prospective diaries. The mean number of migraine days per cycle was 4.2 (± 2.7). Around 50% of these migraines occurred during the hormone-free interval. Migraine frequency was significantly higher in women who suffered from migraine before CHC start (5.0 ± 3.1) (n = 22) in comparison to those with migraine onset after CHC start (3.5 ± 2.1) (n = 26). Menstrually related attacks were described as more painful (57.5%), especially in women with migraine onset before CHC use (72%) (p < 0.02). Comorbidities were rare, except dysmenorrhea. The majority of migraine attacks in CHC users occur during the hormone-free interval. Similar as in the natural cycle, hormone-withdrawal migraines in CHC users are very intense and the response to acute medication is less good, especially in those women, who developed migraine before CHC use.
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http://dx.doi.org/10.1007/s13760-021-01677-3DOI Listing
April 2021

A core outcome set for vasomotor symptoms associated with menopause: the COMMA (Core Outcomes in Menopause) global initiative.

Menopause 2021 Apr 26. Epub 2021 Apr 26.

Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Australia Obstetrics and Gynaecology, Eastern Virginia Medical School, Norfolk, VA Women's Health Research Program, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia School of Nursing, Indiana University, Indianapolis, IN Department of Obstetrics and Gynaecology, University of Chicago, Chicago, IL Red Hot Mamas North America, Inc, Town of Ridgefield, CT Obstetrics and Gynecology, New York University School of Medicine, New York, NY Department of Obstetrics and Gynaecology, University Hospitals Dorset NHS Trust, Poole, Dorset, UK Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK Centre for Women's Health, Institute of Population Health Sciences, Queen Mary University London, London, UK Department of Obstetrics and Gynaecology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand Connors Center for Women's Health and Gender Biology and the Department of Psychiatry, Brigham and Women's Hospital, Harvard Medical School, Boston, MA Department of Obstetrics and Gynaecology, Fortis Escort Hospital, Jaipur, India Department of Gynaecology and Obstetrics, University of Muenster, Muenster, Germany Adelaide Medical School, Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, Australia Amsterdam Reproduction and Development, Center for Reproductive Medicine, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, The Netherlands Department of Reproductive and Maternal medicine, School of Medicine, University of Glasgow, Glasgow, UK University of Illinois at Chicago, Departments of Psychiatry, Psychology and Obstetrics and Gynecology, Chicago, IL Research Center for Reproductive Medicine, Gynecological Endocrinology and Menopause, IRCCS San Matteo Foundation, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy Queen Charlotte's and Chelsea and Chelsea and Westminster Hospitals, Imperial College London, London, UK Auckland District Health Board, Auckland, New Zealand Midlife Women's Health Center, Department of Obstetrics and Gynecology, Massachusetts General Hospital, Harvard Medical School, Boston, MA Department of Obstetrics and Gynecology, George Washington University, Washington, DC Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, Clayton, Victoria, Australia Department of Obstetrics and Gynaecology, University of Toronto, Toronto, Canada.

Objective: Vasomotor symptoms (VMS) (hot flashes and night sweats) affect most women over the menopause transition. Comparing the safety and effectiveness of treatments for vasomotor symptoms is limited by the use of inconsistent outcome measures, and uncertainty as to which outcomes are most important to symptomatic women. To address this, we have developed a Core Outcome Set (COS) for use in clinical trials of treatments for VMS.

Methods: We systematically reviewed the primary outcomes measured in randomized controlled trials of treatments for VMS. These were refined and entered into a two-round modified Delphi survey completed by clinicians, researchers, and postmenopausal women between November 2019 and March 2020. Outcomes were scored on a nine-point scale from "not important" to "critically important." Two international consensus meetings were held to finalize the COS.

Results: Based on the systematic review, 13 separate outcomes were included in the Delphi process. This was completed by 227 participants of whom 58% were postmenopausal women, 34% clinicians, and 8% researchers. Predefined thresholds were applied to categorize importance scores obtained during Round 2 of the Delphi survey. These informed discussions at the consensus meetings which were attended by 56 participants from 28 countries. The final COS includes six outcomes: 1) frequency of VMS, 2) severity of VMS, 3) distress, bother or interference caused by VMS, 4) impact on sleep, 5) satisfaction with treatment, and 6) side-effects of treatment.

Conclusion: Implementation of this COS will: better enable research studies to accurately reflect the joint priorities of postmenopausal women, clinicians and researchers, standardize outcome reporting, and facilitate combining and comparing results from different studies, and ultimately improve outcomes for women with bothersome VMS.

Video Summary:http://links.lww.com/MENO/A763.
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http://dx.doi.org/10.1097/GME.0000000000001787DOI Listing
April 2021

The Gynogram: A Multicentric Validation of a New Psychometric Tool to Assess Coital Pain Associated With VVA and Its Impact on Sexual Quality of Life in Menopausal Women.

J Sex Med 2021 05 23;18(5):955-965. Epub 2021 Apr 23.

Chair of Endocrinology and Medical Sexology (ENDOSEX), Department of Systems Medicine, Tor Vergata University of Rome, Rome, Italy. Electronic address:

Background: Vulvo-Vaginal Atrophy (VVA) affects about fifty percent of postmenopausal women, contributing more vulnerable sexual and psycho-relational equilibrium. To date, no psychometric instruments have been designed to assess the impact of coital pain associated with VVA on sexual quality of life.

Aim: To validate a new psychometric tool, the Gynogram, able to investigate coital pain and to quantify its impact on sexual well-being in menopause.

Methods: 214 sexually active postmenopausal women were enrolled in the study during clinical consultations in gynecological outpatient clinics in Italy. After gynecological examination and evaluation of the presence of VVA, the study sample was divided in a clinical group (103 women with certified diagnosis of VVA) and in a control group (111 women without certified diagnosis of VVA) according to the Vaginal Health Index (VHI) cut-off. Factor, Reliability and Receiving Operating Characteristics (ROC) analysis were performed in order to validate our newly created Gynogram.

Outcomes: A structured questionnaire, named Gynogram, to assess coital pain and its impact, and the Female Sexual Function Index (FSFI).

Results: The factor analysis performed on the original form (80 items) reduced the Gynogram to 24 items. Reliability analysis conducted with Cronbach's Alpha coefficients showed high values in all the components (ranging from .813 to .972), both in the long and in the short form. The sensitivity analysis demonstrated that the Gynogram, with a cut-off ≤93, is able to recognize a clinically significant coital pain. With respect to the FSFI, statistically significant differences were found for all the domains. In addition, statistically significant differences were found for all the twelve factors of the Gynogram, showing that VVA profoundly affects the sexual quality of life of women in post-menopause.

Clinical Translation: The utility of this tool consists in the possibility to improve prognosis, compliance/adherence and treatment outcomes.

Strengths And Limitations: The Gynogram is able to evaluate and to quantify the impact of coital pain associated with VVA. Moreover, it can also recognize the areas of biopsychosocial functioning being more affected by this clinical condition. The main limit of the study is the impossibility to evaluate both mental health and partner's general and sexual health.

Conclusions: The Gynogram is a new and validated psychometric tool able to detect the impact of symptomatic VVA on sexual quality of life among post-menopausal women, with a specific focus on the different areas of sexual functioning. Nappi RE, Graziottin A, Mollaioli A, et al. The Gynogram: A Multicentric Validation of a New Psychometric Tool to Assess Coital Pain Associated With VVA and Its Impact on Sexual Quality of Life in Menopausal Women. J Sex Med 2021;18:955-965.
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http://dx.doi.org/10.1016/j.jsxm.2021.02.011DOI Listing
May 2021

Efficacy and safety of a new vaginal gel for the treatment of symptoms associated with vulvovaginal atrophy in postmenopausal women: A double-blind randomized placebo-controlled study.

Maturitas 2021 May 4;147:34-40. Epub 2021 Mar 4.

Research Center for Reproductive Medicine, Gynecological Endocrinology and Menopause, Obstetrics and Gynecology Unit, IRCCS S. Matteo Foundation, Department of Clinical, Surgical, Diagnostic and Paediatric Sciences, University of Pavia, Viale Camillo Golgi, 19, 27100 Pavia, Italy. Electronic address:

Objective: The aim of the present randomized placebo-controlled single-center study was to assess the efficacy and safety of a new vaginal gel (Meclon Idra - Alfasigma) in the treatment of vulvovaginal atrophy (VVA). The gel is composed of sea buckthorn (Hippophaë rhamnoides) oil, aloe vera, 18β-glycyrrhetic acid, hyaluronic acid and glycogen. The study assessed whether the gel can reduce VVA symptoms (vaginal dryness, itching, burning sensation) and improve sexual function in postmenopausal women over 12 weeks.

Study Design: Postmenopausal women (n° = 60) reporting VVA symptoms were recruited and randomized in a 1:1 ratio to the gel or placebo. Active vaginal gel or placebo was applied for 14 days and then twice a week for 90 consecutive days.

Main Outcome Measure: The Vaginal Health Index (VHI), including vaginal pH, was used to assess changes in objective signs, whereas the self-reported Female Sexual Function Index (FSFI) was used to investigate sexual function.

Results: Meclon Idra was effective in reducing vaginal pain, dyspareunia and vaginal pH, with the VHI showing significant improvement at day 90 (P < .0001), and in reducing each VVA symptom (vaginal dryness, vaginal itching, burning sensation) at weeks 2 and 4, and the end of the study (P < .0001). The analysis of FSFI scores showed, after the end of treatment, an improvement of sexual function in the active-treatment group, with a statistically significant increase (P < 0.001) in all domains scores and total score (P < 0.001).

Conclusions: The present single-center randomized clinical trial demonstrated the efficacy, tolerability and safety of 12-week treatment with a new vaginal gel in postmenopausal women with symptoms associated with VVA. Based on this trial, the gel seems to be a valid choice as a single, local agent for relieving VVA symptoms and improving sexual function, and to have good compliance. This trial is registered prospectively with the Clinical Trials Registry - India, number CTRI/2019/05/01911.
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http://dx.doi.org/10.1016/j.maturitas.2021.03.002DOI Listing
May 2021

International Society for the Study of Women's Sexual Health Clinical Practice Guideline for the Use of Systemic Testosterone for Hypoactive Sexual Desire Disorder in Women.

J Sex Med 2021 05 1;18(5):849-867. Epub 2021 Apr 1.

Andrology, Women's Endocrinology & Gender Incongruence Unit, Department of "Excellence" Experimental and Clinical Biomedical Sciences "Mario Serio"-Careggi Hospital-University of Florence, Florence, Italy; Consorzio Interuniversitario I.N.B.B., Rome, Italy.

Background: The Global Consensus Position Statement on the Use of Testosterone Therapy for Women (Global Position Statement) recommended testosterone therapy for postmenopausal women with hypoactive sexual desire disorder (HSDD).

Aim: To provide a clinical practice guideline for the use of testosterone including identification of patients, laboratory testing, dosing, post-treatment monitoring, and follow-up care in women with HSDD.

Methods: The International Society for the Study of Women's Sexual Health appointed a multidisciplinary panel of experts who performed a literature review of original research, meta-analyses, review papers, and consensus guidelines regarding testosterone use in women. Consensus was reached using a modified Delphi method.

Outcomes: A clinically useful guideline following a biopsychosocial assessment and treatment approach for the safe and efficacious use of testosterone in women with HSDD was developed including measurement, indications, formulations, prescribing, dosing, monitoring, and follow-up.

Results: Although the Global Position Statement endorses testosterone therapy for only postmenopausal women, limited data also support the use in late reproductive age premenopausal women, consistent with the International Society for the Study of Women's Sexual Health Process of Care for the Management of HSDD. Systemic transdermal testosterone is recommended for women with HSDD not primarily related to modifiable factors or comorbidities such as relationship or mental health problems. Current available research supports a moderate therapeutic benefit. Safety data show no serious adverse events with physiologic testosterone use, but long-term safety has not been established. Before initiation of therapy, clinicians should provide an informed consent. Shared decision-making involves a comprehensive discussion of off-label use, as well as benefits and risks. A total testosterone level should not be used to diagnose HSDD, but as a baseline for monitoring. Government-approved transdermal male formulations can be used cautiously with dosing appropriate for women. Patients should be assessed for signs of androgen excess and total testosterone levels monitored to maintain concentrations in the physiologic premenopausal range. Compounded products cannot be recommended because of the lack of efficacy and safety data.

Clinical Implications: This clinical practice guideline provides standards for safely prescribing testosterone to women with HSDD, including identification of appropriate patients, dosing, and monitoring.

Strengths & Limitations: This evidence-based guideline builds on a recently published comprehensive meta-analysis and the Global Position Statement endorsed by numerous societies. The limitation is that testosterone therapy is not approved for women by most regulatory agencies, thereby making prescribing and proper dosing challenging.

Conclusion: Despite substantial evidence regarding safety, efficacy, and clinical use, access to testosterone therapy for the treatment of HSDD in women remains a significant unmet need. Parish SJ, Simon JA, Davis SR, et al. International Society for the Study of Women's Sexual Health Clinical Practice Guideline for the Use of Systemic Testosterone for Hypoactive Sexual Desire Disorder in Women. J Sex Med 2021;18:849-867.
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http://dx.doi.org/10.1016/j.jsxm.2020.10.009DOI Listing
May 2021

International Society for the Study of Women's Sexual Health Clinical Practice Guideline for the Use of Systemic Testosterone for Hypoactive Sexual Desire Disorder in Women.

J Womens Health (Larchmt) 2021 04 1;30(4):474-491. Epub 2021 Apr 1.

Andrology, Women's Endocrinology & Gender Incongruence Unit, Department of "Excellence" Experimental and Clinical Biomedical Sciences "Mario Serio"-Careggi Hospital-University of Florence, Florence, Italy.

The Global Consensus Position Statement on the Use of Testosterone Therapy for Women (Global Position Statement) recommended testosterone therapy for postmenopausal women with hypoactive sexual desire disorder (HSDD). To provide a clinical practice guideline for the use of testosterone including identification of patients, laboratory testing, dosing, post-treatment monitoring, and follow-up care in women with HSDD. The International Society for the Study of Women's Sexual Health appointed a multidisciplinary panel of experts who performed a literature review of original research, meta-analyses, review papers, and consensus guidelines regarding testosterone use in women. Consensus was reached using a modified Delphi method. A clinically useful guideline following a biopsychosocial assessment and treatment approach for the safe and efficacious use of testosterone in women with HSDD was developed including measurement, indications, formulations, prescribing, dosing, monitoring, and follow-up. Although the Global Position Statement endorses testosterone therapy for only postmenopausal women, limited data also support the use in late reproductive age premenopausal women, consistent with the International Society for the Study of Women's Sexual Health Process of Care for the Management of HSDD. Systemic transdermal testosterone is recommended for women with HSDD not primarily related to modifiable factors or comorbidities such as relationship or mental health problems. Current available research supports a moderate therapeutic benefit. Safety data show no serious adverse events with physiologic testosterone use, but long-term safety has not been established. Before initiation of therapy, clinicians should provide an informed consent. Shared decision-making involves a comprehensive discussion of off-label use, as well as benefits and risks. A total testosterone level should not be used to diagnose HSDD, but as a baseline for monitoring. Government-approved transdermal male formulations can be used cautiously with dosing appropriate for women. Patients should be assessed for signs of androgen excess and total testosterone levels monitored to maintain concentrations in the physiologic premenopausal range. Compounded products cannot be recommended because of the lack of efficacy and safety data. This clinical practice guideline provides standards for safely prescribing testosterone to women with HSDD, including identification of appropriate patients, dosing, and monitoring. This evidence-based guideline builds on a recently published comprehensive meta-analysis and the Global Position Statement endorsed by numerous societies. The limitation is that testosterone therapy is not approved for women by most regulatory agencies, thereby making prescribing and proper dosing challenging. Despite substantial evidence regarding safety, efficacy, and clinical use, access to testosterone therapy for the treatment of HSDD in women remains a significant unmet need.
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http://dx.doi.org/10.1089/jwh.2021.29037DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8064950PMC
April 2021

International Society for the Study of Women's Sexual Health Clinical Practice Guideline for the Use of Systemic Testosterone for Hypoactive Sexual Desire Disorder in Women.

Climacteric 2021 Apr 1:1-18. Epub 2021 Apr 1.

Andrology, Women's Endocrinology & Gender Incongruence Unit, Department of "Excellence" Experimental and Clinical Biomedical Sciences "Mario Serio", Careggi Hospital-University of Florence, Florence, Italy.

Aim: To provide a clinical practice guideline for the use of testosterone including identification of patients, laboratory testing, dosing, post-treatment monitoring, and follow-up care in women with hypoactive sexual desire disorder (HSDD).

Methods: The International Society for the Study of Women's Sexual Health appointed a multidisciplinary panel of experts who performed a literature review of original research, meta-analyses, review papers, and consensus guidelines regarding testosterone use in women. Consensus was reached using a modified Delphi method.

Outcomes: A clinically useful guideline following a biopsychosocial assessment and treatment approach for the safe and efficacious use of testosterone in women with HSDD was developed including measurement, indications, formulations, prescribing, dosing, monitoring, and follow-up.

Results: Although the Global Position Statement endorses testosterone therapy for only postmenopausal women, limited data also support the use in late reproductive age premenopausal women, consistent with the International Society for the Study of Women's Sexual Health Process of Care for the Management of HSDD. Systemic transdermal testosterone is recommended for women with HSDD not primarily related to modifiable factors or comorbidities such as relationship or mental health problems. Current available research supports a moderate therapeutic benefit. Safety data show no serious adverse events with physiologic testosterone use, but long-term safety has not been established. Before initiation of therapy, clinicians should provide an informed consent. Shared decision-making involves a comprehensive discussion of off-label use, as well as benefits and risks. A total testosterone level should not be used to diagnose HSDD, but as a baseline for monitoring. Government-approved transdermal male formulations can be used cautiously with dosing appropriate for women. Patients should be assessed for signs of androgen excess and total testosterone levels monitored to maintain concentrations in the physiologic premenopausal range. Compounded products cannot be recommended because of the lack of efficacy and safety data.

Clinical Implications: This clinical practice guideline provides standards for safely prescribing testosterone to women with HSDD, including identification of appropriate patients, dosing, and monitoring.

Strengths And Limitations: This evidence-based guideline builds on a recently published comprehensive meta-analysis and the Global Position Statement endorsed by numerous societies. The limitation is that testosterone therapy is not approved for women by most regulatory agencies, thereby making prescribing and proper dosing challenging.

Conclusion: Despite substantial evidence regarding safety, efficacy, and clinical use, access to testosterone therapy for the treatment of HSDD in women remains a significant unmet need.
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http://dx.doi.org/10.1080/13697137.2021.1891773DOI Listing
April 2021

Microablative Fractional CO Laser for Vulvovaginal Atrophy in Women With a History of Breast Cancer: A Pilot Study at 4-week Follow-up.

Clin Breast Cancer 2021 Feb 23. Epub 2021 Feb 23.

School of Medicine, Vita-Salute San Raffaele University, Milan, Italy; Division of Gynecology and Obstetrics, Urogynecology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.

Background: Breast cancer (BC) is the most common female cancer worldwide. Menopausal symptoms are a well-known side effect in women with BC and have a significant negative impact on quality of life (QoL) and sexuality. Nowadays, hormonal replacement therapy and local estrogens are the most common prescriptions to treat vulvovaginal (VVA) symptoms. However, in women with a history of BC, proper therapy for such conditions remains an often inadequately addressed clinical problem. A treatment with microablative fractional CO laser (MLT) can produce a remodeling of the vaginal connective tissue without causing damage to the surrounding tissue. The aim of this pilot study is to assess the efficacy and safety of MLT for treating VVA symptoms in women with a history of BC at 20-week follow-up since the first laser treatment.

Patients And Methods: Women with BC and VVA symptoms were enrolled in the study and treated with 5 laser applications (one every 4 weeks). The rate of satisfied patients at 20 weeks of follow-up was evaluated with a 5-point Likert scale. Changes of the Vaginal Health Index (VHI) after treatment was compared with baseline. Effects of the laser treatment on VVA symptoms was measured using a 10-cm visual analog scale (VAS). Changes in overall QoL were assessed with a generic QoL questionnaire: the Short Form 12 (SF-12) that we analyzed considering its physical (PCS12) and mental (MCS12) domains. Sexual function was evaluated by the Female Sexual Function Index (FSFI).

Results: In this prospective cohort study, we enrolled 40 women with a history of BC and who currently were or (Group 2) who had been (Group 1) on treatment with endocrine therapy for their condition. Six (15.0%) women were very satisfied, 25 (62.5%) were satisfied, 6 (15.0%) were uncertain, and 3 (7.5%) were dissatisfied with the MLT. VVA symptoms and VHI improved significantly at 20 weeks from baseline (P < .05) with no differences between the 2 groups (P > .05). In terms of QoL measured by the SF-12, the PCS12 and the MCS12 significantly improved at the 20-week follow-up. A significant improvement in total FSFI and in all domains was reported in both study groups (P < .05) with no differences between groups (P > .05).

Conclusion: MLT was safe and effective in treating VVA symptoms in women with a history of BC, irrespective of being previously or currently on endocrine therapies.
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http://dx.doi.org/10.1016/j.clbc.2021.01.006DOI Listing
February 2021

Prolactin as a neuroendocrine clue in sexual function of women across the reproductive life cycle: an expert point of view.

Gynecol Endocrinol 2021 Jun 11;37(6):490-496. Epub 2021 Mar 11.

Gynecological Endocrinology Center, Department of Obstetrics and Gynecology, University of Modena and Reggio Emilia, Modena, Italy.

Prolactin is a proteic hormone best known for its role in enabling the production of milk by female mammals. Secreted by the pituitary gland in response to the stimuli of eating, estrogen treatment, mating, ovulation and nursing, prolactin is involved in over 300 separate processes in a range of vertebrates, including humans. The hormone is released in a pulsatile manner and plays an essential role in metabolism, as well as in the regulation of the immune system and pancreatic development. Nevertheless, prolactin exerts other relevant roles, as it acts at the central nervous system level to modulate behavior, arousal and sexuality. In this experts' opinion, we aim to give insights into the main activities of prolactin to advance the ability of medical doctors and specialists in obstetrics and gynecology to provide more emphasis in their clinical practices to the link between prolactin and sexuality.
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http://dx.doi.org/10.1080/09513590.2021.1897783DOI Listing
June 2021

Menopause transition: a golden age to prevent cardiovascular disease.

Lancet Diabetes Endocrinol 2021 03 21;9(3):135-137. Epub 2021 Jan 21.

Division of Obstetrics and Gynecology, Department of Clinical and Experimental Medicine, University of Pisa, Pisa 56126, Italy.

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http://dx.doi.org/10.1016/S2213-8587(21)00018-8DOI Listing
March 2021

Vulvovaginal atrophy of menopause and its impact on sexual function in an Italian clinical cohort of post-menopausal women.

J Obstet Gynaecol 2021 Feb 12;41(2):290-297. Epub 2021 Jan 12.

University of Rome "Sapienza", Department of Gynaecological-Obstetric Sciences and Urological Sciences, Umberto I Hospital, Rome, Italy.

The aim of current study was to estimate the impact of vulvovaginal atrophy (VVA) on sexual function in a clinical population of Italian postmenopausal women. Women aged 45-75 years with at least one VVA symptom completed three questionnaires: Day-to-Day Impact of Vaginal Aging (DIVA), Female Sexual Function Index (FSFI) and Female Sexual Distress Scale revised (FSDS-R). A gynaecological examination was performed for VVA confirmation. Among the 1,066 evaluable patients, VVA was confirmed in around 90% of the sample. Sexual function impairment was significantly higher in patients with confirmed VVA as observed by significant differences in the sexual function component of the DIVA questionnaire ( = .014), the FSDS-R ( < .0005), and the FSFI ( < .0005), as well as for all the FSFI subdomains: desire ( < .0005), arousal ( < .0005), lubrication ( < .0005), orgasm ( < .0005), satisfaction ( < .0005) and pain ( < .0005). Significant impairment of sexual function was demonstrated in Italian postmenopausal women who were clinically confirmed with signs of VVA through gynaecological examination.IMPACT STATEMENT At least half of postmenopausal women report VVA associated symptoms with significant impact on sexual function and ultimately on sexual activity. As compared with patients without confirmed VVA, the negative impact on sexual function was significantly higher in patients with confirmed VVA. This difference was observed for the sexual function component (DIVA-C) of the DIVA questionnaire, for the overall FSDS-R result, and for the overall FSFI score, as well as for all the FSFI subdomains (desire, arousal, lubrication, orgasm, satisfaction and pain). An impairment of sexual function is significantly associated with VVA diagnosis in Italian post-menopausal women, especially when diagnosis was objectively confirmed by clinical signs of VVA visible in the gynaecological examination. In addition, this study demonstrates that inquiring about VVA using a structured questionnaire may increase the diagnosis of VVA related changes in sexual function.
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http://dx.doi.org/10.1080/01443615.2020.1832973DOI Listing
February 2021

Myeloperoxidase and lactoferrin expression in semen fluid: Novel markers of male infertility risk?

Immunobiology 2020 09 5;225(5):151999. Epub 2020 Aug 5.

Center for Reproductive Medicine - Obstetrics and Gynecology Unit, Woman and Child Health Department, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy; Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Italy.

Research Question: Infections and/or inflammation processes of male genital tract are highly prevalent and often associated with risk of infertility. These conditions represent a possible cause of leukocytospermia, which is still under debate. Leukocytes are key-factors to reactive oxygen species (ROS) production and the increase of ROS in semen fluid is associated with the worsening of semen parameters. At present, there are not appropriate andrological tests to identify asymptomatic inflammatory conditions when the amount of leukocytes is in the normal range.

Design: We studied the innate immunity profile of myeloperoxidase and lactoferrin (MPO/LAC) proteins expressed in the semen fluid of 39 men evaluated for couple infertility, in the absence of leukocytospermia.

Results: The presence of both MPO and LAC proteins was associated with a decrease of sperm concentration and of progressive/total motility, whereas the increase of MPO-/LAC + indicated a worse sperm morphology. It is worth to report the predictive potential of MPO+/LAC + pattern (above 4.36 %) as a biological marker to distinguish normozoospermic from pathological patients.

Conclusion: Our findings indicate MPO/LAC analysis as a potential diagnostic tool to identify asymptomatic conditions eventually related to male infertility, even when the number of leukocytes in semen fluid is below 1 million/mL.
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http://dx.doi.org/10.1016/j.imbio.2020.151999DOI Listing
September 2020

The European Vulvovaginal Epidemiological Survey (EVES). Impact of history of breast cancer on prevalence, symptoms, sexual function and quality of life related to vulvovaginal atrophy.

Gynecol Endocrinol 2021 Jan 28;37(1):78-82. Epub 2020 Aug 28.

Queen Charlotte's & Chelsea and Westminster Hospitals, Imperial College London, London, UK.

Objective: Women with history of breast cancer (HBC) frequently suffer from vulvovaginal atrophy (VVA). European Vulvovaginal Epidemiology Survey (EVES) sub-analysis assesses the impact of HBC on VVA, sexual life and quality of life (QoL) in postmenopausal women.

Materials And Methods: Women with at least one VVA symptom aged 45-75 years were included. EuroQol (EQ-5D-3L) and Day-to-Day Impact of Vaginal Aging (DIVA) questionnaires were filled to investigate QoL. VVA diagnosis was confirmed with objective gynecological examination. Comparison of postmenopausal women with and without HBC, and evaluation of treatment impact on VVA were performed.

Results: 1985 postmenopausal women without HBC and 175 with HBC were included. VVA was confirmed in 90.4% of women without HBC and 91.4% of women with HBC. There were no differences in VVA symptoms severity or vulvovaginal discomfort between groups. However, women with HBC who had completed treatment and had surgery 11-20 years previously versus those without HBC presented significantly worse Vaginal Health Index scores, as well as a higher prevalence of VVA objective diagnosis, although their overall symptom severity score was lower. Health status and QoL comparisons were similar.

Conclusions: Results support a similar burden in terms of VVA prevalence and symptoms, QoL and sexual function in postmenopausal women with and without HBC.
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http://dx.doi.org/10.1080/09513590.2020.1813273DOI Listing
January 2021

Fundamental Concepts and Novel Aspects of Polycystic Ovarian Syndrome: Expert Consensus Resolutions.

Front Endocrinol (Lausanne) 2020 11;11:516. Epub 2020 Aug 11.

Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.

Polycystic ovary syndrome (PCOS) is a very common endocrine and metabolic disorder with the involvement of both genetic and environmental factors. Although much has been clarified on its pathogenesis, diagnosis, clinical manifestations, and therapy, there are still areas of uncertainty. To address fundamental concepts, novel aspects and hypotheses, and future perspectives, including the possible additional benefits of treatment with nutraceuticals, an expert consensus panel formed by endocrinologists and gynecologists was established. After an independent review of the literature, the panel convened electronically on February 3, 2020, and six resolutions were created, debated, and agreed upon discussion, and finally approved in their final form in a consensus livestream meeting held on April 15. The summary of the resolutions are: (1) PCOS is a well-established medical condition that negatively affects reproduction, general health, sexual health, and quality of life; (2) the symptoms and signs of PCOS appear early in life especially in female newborns from PCOS carriers; (3) women with PCOS have significantly increased risk of pregnancy-related complications including gestational diabetes mellitus; (4) a male PCOS equivalent exists, and it may impact on metabolic health and probably on reproduction; (5) the evidence supports that medical therapy for PCOS is effective, rational, and evidence-based; (6) the evidence supports a major research initiative to explore possible benefits of nutraceutical therapy for PCOS. The proposed resolutions may be regarded as points of agreement based on the current scientific evidence available.
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http://dx.doi.org/10.3389/fendo.2020.00516DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7431619PMC
June 2021

"50 Shades of sex" under hormonal contraception.

Gynecol Endocrinol 2020 Sep 21;36(9):753-754. Epub 2020 Aug 21.

Research Center for Reproductive Medicine, Gynecological Endocrinology and Menopause, IRCCS San Matteo Foundation, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy.

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http://dx.doi.org/10.1080/09513590.2020.1811847DOI Listing
September 2020

Viewing symptoms associated with Vulvovaginal Atrophy (VVA)/Genitourinary syndrome of menopause (GSM) through the estro-androgenic lens - Cluster analysis of a web-based Italian survey among women over 40.

Maturitas 2020 Oct 25;140:72-79. Epub 2020 Jun 25.

Department of Obstetrics and Gynecology, University Hospital S. Anna, Pisa, Italy.

Objective: we aimed to explore the use of an estro-androgenic symptom questionnaire in women (EASQ-W), including items typically associated with menopausal hypoestrogenism and some others possibly related to androgen insufficiency that may be relevant to further characterize women reporting VVA/GSM at midlife.

Methods: web-based survey involving a representative sample of 1505 Italian women (age range: 40-65 years). The responders completed a structured, online questionnaire, reporting symptoms (yes/no option) and rating them (from 1 to 10), if present during the past 4 weeks. A factor analysis methodology (principal component analysis and K-MEANS clustering algorithm) was used to segment women. Statistically significant differences between groups were determined at the 95 % level of confidence.

Results: more than half of our study sample were aged 50-65 years (n = 901; 59.9 %) and 55 % were postmenopausal women (PMW). We obtained 8 principal domains of the EASQ-W with PMW reporting significantly more severe symptoms in the majority of domains related to well-being at mid-life. The K-MEANS clustering algorithm identified 4 clusters of women characterized by different symptoms: vasomotor (VMS; n = 341), sexual (SEX; n = 301), poorly symptomatic (LOWSYMPT; n = 766), sexual and anatomic, mainly at genital level (SEX + ANAT; n = 97), independently from the menopausal status. The cluster SEX + ANAT was the one reporting overall more symptoms in each of the other principal domains. Some symptoms (impression of being diminished in height, deterioration in work performance, more memory lapses/confusion than before, more wrinkles/signs of aging in the mirror, put on more tummy than usual) and the entire urological (UROL) cluster were significantly more reported by women in the cluster SEX + ANAT. Even when only severe symptoms were analysed, women in the SEX + ANAT cluster were the ones more symptomatic. The SEX only cluster identified younger women, with significantly less day and night hot flushes and sweats and less vaginal dryness and low lubrication associated with sexual pain as compared to SEX + ANAT.

Conclusion: our results provide insight into the constellation of symptoms associated with VVA/GSM by identifying women with distinct clusters of complaints that may require a tailored diagnostic and therapeutic approach across age and menopause.
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http://dx.doi.org/10.1016/j.maturitas.2020.06.018DOI Listing
October 2020

Obesity, Polycystic Ovary Syndrome, and Infertility: A New Avenue for GLP-1 Receptor Agonists.

J Clin Endocrinol Metab 2020 08;105(8)

Research Center for Reproductive Medicine, Gynecological Endocrinology and Menopause, IRCCS San Matteo Foundation, Pavia, Italy.

Context: Obesity is responsible for an increased risk of sub-fecundity and infertility. Obese women show poorer reproductive outcomes regardless of the mode of conception, and higher body mass index (BMI) is associated with poorer fertility prognosis. Polycystic ovary syndrome (PCOS) is one of the leading causes of infertility, and many women with PCOS are also overweight or obese.

Evidence Acquisition: The aim of the present narrative review is to describe the mechanisms responsible for the development of infertility and PCOS in women with obesity/overweight, with a focus on the emerging role of glucagon-like peptide-1 (GLP-1) receptor agonists (GLP-1 RAs) as a therapeutic option for obese women with PCOS.

Evidence Synthesis: Weight reduction represents the most significant factor affecting fertility and pregnancy outcomes. Current experimental and clinical evidence suggests the presence of an underlying pathophysiological link between obesity, GLP-1 kinetic alterations, and PCOS pathogenesis. Based on the positive results in patients affected by obesity, with or without diabetes, the administration of GLP-1 RA (mainly liraglutide) alone or in combination with metformin has been investigated in women with obesity and PCOS. Several studies demonstrated significant weight loss and testosterone reduction, with mixed results relative to improvements in insulin resistance parameters and menstrual patterns.

Conclusions: The weight loss effects of GLP-1 RA offer a unique opportunity to expand the treatment options available to PCOS patients.
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http://dx.doi.org/10.1210/clinem/dgaa285DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7457958PMC
August 2020

HPV Infection Affects Human Sperm Functionality by Inhibition of Aquaporin-8.

Cells 2020 05 17;9(5). Epub 2020 May 17.

Department of Molecular Medicine, Human Physiology Unit, University of Pavia, I-27100 Pavia, Italy.

Human sperm cells express different aquaporins (AQPs), AQP3, 7, 8, 11, which are localized both in the plasma membrane and in intracellular structures. Besides cell volume regulation and end stage of cytoplasm removal during sperm maturation, the role of AQPs extends also to reactive oxygen species (ROS) elimination. Moreover, oxidative stress has been shown to inhibit AQP-mediated HO permeability. A decrease in AQPs functionality is related to a decrease in sperm cells number and motility. Here we investigate the possible effect of human Papillomavirus (HPV) on both expression and function of AQPs in human sperm cells of patients undergoing infertility couple evaluation. Stopped-flow light-scattering experiments demonstrated that HPV infection heavily reduced water permeability of sperm cells in normospermic samples. Confocal immunofluorescence experiments showed a colocalization of HPV L1 protein with AQP8 (Pearson's correlation coefficient of 0.61), confirmed by co-immunoprecipitation experiments. No interaction of HPV with AQP3 and AQP7 was observed. A 3D model simulation of L1 protein and AQP8 interaction was also performed. Present findings may suggest that HPV infection directly inhibits AQP8 functionality and probably makes sperm cells more sensitive to oxidative stress.
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http://dx.doi.org/10.3390/cells9051241DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7291193PMC
May 2020

SARS-CoV-2, testosterone and frailty in males (PROTEGGIMI): A multidimensional research project.

Andrology 2021 01 22;9(1):19-22. Epub 2020 Jun 22.

Andrology, Female Endocrinology and Gender Incongruence Unit, Department of Experimental, Clinical and Biomedical Sciences "Mario Serio", University of Florence, Florence, Italy.

Preliminary published data depict a much greater prevalence of males with laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) referred for intensive care unit admission and severe sequelae in several countries. In this context, males seem to not only be more susceptible to the infection compared to female subjects, at least in Western countries, but their case fatality rate attributable to SARS-CoV-2 infection is also highest. Therefore, we may speculate that the different hormonal milieu could have a more profound pathophysiological role in association with SARS-CoV-2, with endogenous testosterone leaving men more prone to develop more serious complications related to the SARS-CoV-2 infection. Another option is that SARS-CoV-2 infection per se causes an acute stage of male hypogonadism, the depletion of androgenic action triggering serious or an even fatal course of the disease. Therefore, we strongly advocate the development of a prospective multidimensional andrological translational research project in men, which we called the PROTEGGIMI study. In this Opinion Article, we will not only highlight novel research activity in this area but also invite other researchers and learned scientific societies to join us in our efforts to understand an important and very newly discovered gap in knowledge, which may have serious implications for the lives of millions of men.
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http://dx.doi.org/10.1111/andr.12811DOI Listing
January 2021

Gender Differences at the Onset of Autoimmune Thyroid Diseases in Children and Adolescents.

Front Endocrinol (Lausanne) 2020 17;11:229. Epub 2020 Apr 17.

Pediatric and Adolescent Unit, Department of Internal Medicine and Therapeutics, University of Pavia, Pavia, Italy.

The incidence of autoimmune thyroid diseases (ATD) may vary with the beginning of reproductive function, although few reports differentiate the incidence before and during the onset of puberty, examining gender bias. We analyzed onset of ATD in a pediatric population to assess gender differences in onset age, disease subtype, pubertal status, autoimmune co-morbidity, family history and treatment, focusing on the interaction between gender and pubertal stage. We retrospectively recorded 382 children and adolescents with ATD. In each patient physical examination was considered. The presence of other associated autoimmune diseases (AAD) and familial predisposition was also recorded. Predominant prevalence was noted in females compared to males ( < 0.001), both in Hashimoto's diseases (HD or HT) and Graves' disease (GD) ( < 0.001). Mean age at diagnosis showed no significant difference between sexes ( > 0.05). A higher prevalence in pubertal subjects was noted compared to prepubertal ( < 0.001, particularly HT in early and GD in late pubertal stage), without sexes difference intra-(prepubertal vs. pubertal) and inter-puberty groups (prepubertal vs. early pubertal vs. late pubertal). Both in HT and in GD, the prevalence of autoimmune associated diseases (AAD) was higher in males compared to females ( = 0.04), with similar distribution according to the pubertal maturation. The familial predisposition was similarly distributed in both genders ( > 0.05) and into pubertal stages ( > 0.05). Females are more prone to develop ATD during puberty, earlier in HT than in GD. The effect of puberty is not different between genders, suggesting the role of additional factors other than hormones. The screening for detection of ATD is recommended in all patients with positive family history and other autoimmune diseases, mostly in males. Considerations of gender in pediatrics could be important to define pathogenic mechanisms of ATD and to help in early diagnosis and clinical management.
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http://dx.doi.org/10.3389/fendo.2020.00229DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7181383PMC
May 2021

Oestrogen-free oral contraception with a 4 mg drospirenone-only pill: new data and a review of the literature.

Eur J Contracept Reprod Health Care 2020 Jun 21;25(3):221-227. Epub 2020 Apr 21.

Clinic for Obstetrics and Gynecology, University Hospital Basel, Basel, Switzerland.

The contraceptive pill is an effective and safe method of preventing pregnancy. The progestins used for contraception either are components of a combined hormonal contraceptive (tablets, patches or vaginal rings) or are used alone in progestin-only formulations. Progestin-only contraceptives are available as daily oral preparations, subcutaneous or intramuscular injectables (every 1-3 months), subdermal implants (every 3-5 years) and intrauterine systems (every 3-5 years). Long-acting progestins are highly effective in typical use and have a very low risk profile and few contraindications. A new progestin-only, oestrogen-free contraceptive, drospirenone, in a dosage of 4 mg/day in a 24/4 regimen, has received regulatory approval in the USA and the EU. The molecule has antigonadotropic, antimineralocorticoid, antiestrogenic and antiandrogenic properties. The regimen was chosen to improve the bleeding profile; maintain plasma oestradiol levels at those of the early follicular phase, to avoid hypoestrogenism; and preserve efficacy even with a missed pill, as drospirenone has a half-life of 30-34 h. Clinical studies have shown good efficacy, very low cardiovascular side effects and a favourable bleeding pattern, as well as maintenance of ovulation inhibition after scheduled 24 h delays in pill intake.
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http://dx.doi.org/10.1080/13625187.2020.1743828DOI Listing
June 2020

Talking about genital problems with women aged over 70.

Authors:
Rossella E Nappi

Maturitas 2020 12 6;142:73-74. Epub 2020 Apr 6.

Research Center for Reproductive Medicine, Gynecological Endocrinology and Menopause, IRCCS San Matteo Foundation, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Piazzale Golgi 2, 27100, Pavia, Italy. Electronic address:

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http://dx.doi.org/10.1016/j.maturitas.2020.03.010DOI Listing
December 2020

Pooled analysis of bleeding profile, efficacy and safety of oral oestradiol valerate/dienogest in women aged 25 and under.

Eur J Contracept Reprod Health Care 2020 Apr 12;25(2):98-105. Epub 2020 Mar 12.

Bayer AG, Berlin, Germany.

To evaluate differences in key outcomes between younger and older women receiving the oral contraceptive oestradiol valerate/dienogest (E2V/DNG). We conducted a pooled analysis of primary data from 12 studies of E2V/DNG, stratified by age (≤25 [ = 1309] and >25 [ = 2132] years). Outcomes included safety, efficacy, bleeding profile and hormone-withdrawal-associated symptoms (HWAS). Bleeding and HWAS analyses are also presented for women aged ≤20 years ( = 362). Discontinuations were considered a proxy for patient satisfaction. Results were generally similar for younger and older women. The percentage of women aged ≤25 and >25 years experiencing intracyclic bleeding did not differ between groups (13.4% and 12.8% at cycle 12, respectively), with similar results in women aged ≤20 years (12.7%, cycle 12). Rates of withdrawal bleeding were very similar in women aged ≤25 and >25 years (78.5% and 78.9%, respectively, cycle 12). We also found a similar adjusted Pearl index in the two age groups (0.45 vs 0.57, respectively), similar rates of AEs and HWAS and no difference in discontinuations. Women aged ≤25 and >25 years have a similar experience with an E2V/DNV oral contraceptive, supporting this as an appropriate contraceptive option in younger and older women.
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http://dx.doi.org/10.1080/13625187.2020.1731734DOI Listing
April 2020

The European Vulvovaginal Epidemiological Survey (EVES): impact on sexual function of vulvovaginal atrophy of menopause.

Menopause 2020 04;27(4):423-429

Palacios Institute of Women's Health, Madrid, Spain.

Objective: To estimate the impact of vulvovaginal atrophy (VVA) on sexual function in a clinical population of postmenopausal women.

Methods: Women 45 to 75 years old and more than 12 months after the last menstruation, who attended menopausal/gynecological centers in Italy and Spain, were included. Women with at least one VVA symptom completed the following questionnaires: Day-to-Day Impact of Vaginal Aging (DIVA), Female Sexual Function Index (FSFI), and Female Sexual Distress Scale revised (FSDS-R). A physical gynecological examination was performed to confirm the VVA diagnosis. Data were analyzed by chi-square and Student's t tests.

Results: In all, 2,160 evaluable women were included in the study. VVA was confirmed in 90% of the included participants. The negative impact on sexual function was significantly higher in women with than in women without confirmed VVA, as evaluated with the sexual function component (DIVA-C) of the DIVA questionnaire (P = 0.013). Statistically significant differences (P < 0.0005) were also detected in the scores of overall FSDS-R, the overall FSFI, and of all the FSFI subdomains (desire, arousal, lubrication, orgasm, satisfaction, and pain).

Conclusion: For postmenopausal women with at least one VVA symptom, the presence of physician-confirmed VVA is associated with significant impaired sexual function, as shown by unadjusted analyses. Given the impact on quality of life and the prevalence of VVA, further research to improve and reduce VVA is warranted.
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http://dx.doi.org/10.1097/GME.0000000000001496DOI Listing
April 2020

Vulvovaginal atrophy (VVA) in breast cancer survivors (BCS) is still an unmet medical need: results of an Italian Delphi Panel.

Support Care Cancer 2020 Jun 22;28(6):2507-2512. Epub 2020 Jan 22.

UOSD Ostetricia e Ginecologia - Procreazione Medicalmente Assistita, IRCCS Fondazione Policlinico "S. Matteo", Università degli Studi di Pavia, Pavia, Italy.

Purpose: VVA is a common disease, with approximately 50% of all postmenopausal women having related symptoms. VVA has a significant impact on the personal and sexual lives and on many aspects of women's self-esteem and emotional well-being. It is particularly frequent and severe in patients treated for BC, where it originates significant economic and social costs. Given the lack of published evidence on this subject, a Delphi Panel was carried out to evaluate:The epidemiology of VVA and of its risk-factors/comorbidities in ItalyThe present standard of care and unmet medical needsThe comparison between recent US epidemiological data and the Italian situationThe health resources used in VVA BC The burden of illnessDespite the considerable negative impact on quality of life, a disparity between the high prevalence of this condition and the infrequent clinical diagnosis is documented in medical practice and in surveys. This inaccuracy is thought to be primarily a consequence of patients' unwillingness and/or reluctance to report symptoms in the clinical setting and of health-care professional's difficulty in approaching this sensitive topic during routine consultations.

Methods: A Delphi Panel methodology was used: a first round of written questionnaires, followed by a plenary meeting with a facilitator and by two additional rounds of telephone interviews.

Results: The prevalence of the condition in Italy can be estimated in 115,000 cases out of 380,000 BC survivors. The Panel confirmed that the epidemiological findings of a recent pharmacoeconomic analysis of a US claims database can be applied to Italian patient population. The Panel confirmed also an estimate of 4.25 additional cases/100/yr of UTI (urinary tract infection) in VVA BC patients (vs. a non-VVA-matched population), of 3.68 additional cases of vulvovaginitis, of 6.97 cases of climacteric symptoms, and of 3.64 cases of bone and joint disorders. As far as the resource use is concerned, in the VVA BC populations, 33.4 additional gynecological visits/100/year can be expected, along with 22.8 additional cancer screenings, 7.07 additional outpatient visits and 5.04 screenings for HPV.

Conclusions: Even in Italy, a diagnosis of VVA, especially in a BC population, is associated with a relevant increase in the burden of illness and social costs, compared to a control population matched for age without VVA. This is due essentially to an increase in comorbidities and resource utilization with the consequence that an adequate treatment could reduce the impact of the condition.
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http://dx.doi.org/10.1007/s00520-019-05272-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7181543PMC
June 2020

Hormonal Contraception and Female Sexuality: Position Statements from the European Society of Sexual Medicine (ESSM).

J Sex Med 2019 11 11;16(11):1681-1695. Epub 2019 Sep 11.

Andrology, Women's Endocrinology and Gender Incongruence Unit, Department of Experimental and Clinical Biomedical Sciences "Mario Serio," University of Florence, Florence, Italy. Electronic address:

Introduction: Hormonal contraception is available worldwide in many different forms. Fear of side effects and health concerns are among the main reasons for not using contraceptives or discontinuing their use. Although the safety and efficacy of contraceptives have been extensively examined, little is known about their impact on female sexual function, and the evidence on the topic is controversial.

Aim: To review the available evidence about the effects of hormonal contraceptives on female sexuality in order to provide a position statement and clinical practice recommendations on behalf of the European Society of Sexual Medicine.

Methods: A comprehensive review of the literature was performed.

Main Outcome Measure: Several aspects of female sexuality have been investigated, including desire, orgasmic function, lubrication and vulvovaginal symptoms, pelvic floor and urological symptoms, partner preference, and relationship and sexual satisfaction. For each topic, data were analyzed according to the different types of hormonal contraceptives (combined estrogen-progestin methods, progestin-only methods, and oral or non-oral options).

Results: Recommendations according to the Oxford Centre for Evidence-Based Medicine 2011 Levels of Evidence criteria and specific statements on this topic, summarizing the European Society of Sexual Medicine position, were developed.

Clinical Implications: There is not enough evidence to draw a clear algorithm for the management of hormonal contraception-induced sexual dysfunction, and further studies are warranted before conclusions can be drawn. A careful baseline psychological, sexual, and relational assessment is necessary for the health care provider to evaluate eventual effects of hormonal contraceptives at follow-up.

Strengths & Limitations: All studies have been evaluated by a panel of experts who have provided recommendations for clinical practice.

Conclusion: The effects of hormonal contraceptives on sexual function have not been well studied and remain controversial. Available evidence indicates that a minority of women experience a change in sexual functioning with regard to general sexual response, desire, lubrication, orgasm, and relationship satisfaction. The pathophysiological mechanisms leading to reported sexual difficulties such as reduced desire and vulvovaginal atrophy remain unclear. Insufficient evidence is available on the correlation between hormonal contraceptives and pelvic floor function and urological symptoms. Both S, Lew-Starowicz M, Luria M, et al. Hormonal Contraception and Female Sexuality: Position Statements from the European Society of Sexual Medicine (ESSM). J Sex Med 2019;16:1681-1695.
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http://dx.doi.org/10.1016/j.jsxm.2019.08.005DOI Listing
November 2019
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