175 results match your criteria bioidentical product


Compounded bioidentical hormone therapy: new recommendations from the 2020 National Academies of Sciences, Engineering, and Medicine.

Menopause 2021 Mar 11;28(5):576-578. Epub 2021 Mar 11.

University of California, San Diego, CA.

Abstract: Bioidentical hormones have the exact same chemical and molecular structure as hormones that are produced in the human body. Bioidentical hormones are available as FDA-approved hormone formulations. Nonapproved custom-compounded preparations are marketed as bioidentical, but content is uncertain. Read More

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Menopausal Hormone Therapy and Cardiovascular Disease: The Role of Formulation, Dose, and Route of Delivery.

J Clin Endocrinol Metab 2021 Apr;106(5):1245-1254

Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.

Context: This mini-review provides an overview of menopausal hormone therapy (HT) and cardiovascular disease (CVD) risk, with a focus on the role of hormone formulation, dose, and route of delivery.

Methods: This summary is based on authors' knowledge in the field of menopausal HT and supplemented by a PubMed search using the terms "menopause hormone therapy," "transdermal," "estradiol," "conjugated estrogens," "bioidentical," "cardiovascular disease," "lipoproteins," "glucose," "progestogens," "low dose."

Results: Available evidence indicates that oral unopposed estrogens have a favorable effect on lipoprotein levels, glycemia, insulin, and CVD risk; however, the addition of progestogens blunts the lipid-related effects. Read More

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Gender Bias in the Treatment of Menopausal Women: I am Hot as Hell and Not Going to Take It Anymore, Part 2.

Authors:
Angela DeRosa

Int J Pharm Compd 2021 Jan-Feb;25(1):14-17

Hormonal Health Institute, Scottsdale, Arizona.

This represents part two of a two-part article on the topic of gender bias within hormone replacement therapy and the well-orchestrated attempt by the pharmaceutical industry to eliminate bioidentical hormones, as well as to downplay the important role of compounding pharmacies in fulfilling the needs of women in this longstanding gender gap. Part one of this two-part article was published in the November/December 2020 issue of the International Journal of Pharmaceutical Compounding. That article discussed two of the four most prevalent reasons for this bias, Protecting the Bottom Line and Lack of Patent Protection. Read More

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January 2021

Bioidentical hormones.

Climacteric 2021 Feb 6;24(1):38-45. Epub 2021 Jan 6.

Departments of Obstetrics and Gynecology.

After the results of the Women's Health Initiative trials were published, patient and clinician interest in potential alternatives to conventional hormone therapy (HT) has grown. A commonly used alternative therapy involves custom-compounded steroid hormone preparations, formulated by compounding pharmacies. Many postmenopausal women consider the hormones as natural or bioidentical, in contrast to hormones used in conventional HT, which they consider synthetic. Read More

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February 2021

Bioidentical Oral 17β-Estradiol and Progesterone for the Treatment of Moderate to Severe Vasomotor Symptoms of Menopause.

Ann Pharmacother 2020 Dec 21:1060028020982611. Epub 2020 Dec 21.

Campbell University College of Pharmacy and Health Sciences, Buies Creek, NC, USA.

Objective: To review the efficacy, safety, and available literature regarding the novel combination bioidentical product Bijuva, or 17β-estradiol/progesterone (17β-E/P), for the treatment of moderate to severe menopausal symptoms in cisgender females with an intact uterus.

Data Sources: Literature searches of both PubMed (1966 to October 2020) and Google Scholar were conducted using search terms including , and .

Study Selection And Data Extraction: All articles with studies conducted in cisgender human females and in the English language were considered for review; 18 publications were included. Read More

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December 2020

Compounded Bioidentical Hormone Therapy: The National Academies Weigh In.

JAMA Intern Med 2021 Mar;181(3):370-371

Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

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Postmenopausal Hormone Therapy-Local and Systemic: A Pharmacologic Perspective.

J Clin Pharmacol 2020 12;60 Suppl 2:S74-S85

OB-GYN and Women's Health Institute, Center for Specialized Women's Health, Cleveland Clinic Foundation, Cleveland, Ohio, USA.

Every woman, if she lives long enough, will transition into menopause, and as the US population ages, women will be spending more time in a postmenopausal state than before. For postmenopausal women, the decision to initiate menopausal hormone therapy should be individualized. A thorough evaluation of the patient's cardiovascular, venous thromboembolic, cancer, and fracture risk should be considered along with the woman's quality of life. Read More

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December 2020

Gender Bias in the Treatment of Menopausal Women: I am Hot as Hell and Not Going to Take It Anymore, Part 1.

Authors:
Angela DeRosa

Int J Pharm Compd 2020 Nov-Dec;24(6):466-470

Hormonal Health Institute, Scottsdale, Arizona.

Gender bias within hormone replacement therapy has been prevalent for decades, and the circumstances surrounding this bias continue to worsen. A billion-dollar industry has been built on dozens of testosterone replacement therapies and medications to treat andropause and erectile dysfunction for men; women have been less fortunate. This article discusses this bias and the well-orchestrated attempt by the pharmaceutical industry to eliminate bioidentical hormones, as well as to downplay the important role of compounding pharmacies in fulfilling the needs of women in this longstanding gender gap. Read More

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November 2020

Compounding for women's health: a compounder's perspective - need, regulations, and future.

Authors:
D Boomsma G Lahoud

Climacteric 2021 Feb 2;24(1):32-37. Epub 2020 Nov 2.

Custom Prescriptions of Lancaster LLC, Lancaster, PA, USA.

Compounding medicine involves various health-care professionals working together to produce medications that treat patient conditions including menopause and other women's health-related illnesses. These medications are compounded under the standards and guidelines mandated by individual state pharmacy boards, the US Food and Drug Administration, and other professional organizations. Contrary to commercial medications, the personalized medicine aspect of compounding medications ensures that the patient's allergies, doses, and drug delivery preferences are addressed during formulation. Read More

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February 2021

Compounded bioidentical menopausal hormone therapy - a physician perspective.

Authors:
C A Stuenkel

Climacteric 2021 Feb 19;24(1):11-18. Epub 2020 Oct 19.

University of California, San Diego, School of Medicine, La Jolla, CA, USA.

One of the defining moments of the 80-year evolution of menopausal hormone therapy (MHT) was the 2002 reveal of the initial results of the combined hormone therapy arm of the Women's Health Initiative (WHI) clinical trial. The exodus from regulatory approved MHT was prompt and profound and accompanied by a rapid acceleration of the compounding pharmacy 'bioidentical' hormone therapy industry. Compounders had recruited prescribers and promoted compounded bioidentical hormone therapy (cBHT) well before the WHI, yet the startling results provided a catalyst that enabled a leap in production of compounded hormones that were variably regulated, basically unstudied, and inconsistently labeled. Read More

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February 2021

Drugs for menopausal symptoms.

Authors:

Med Lett Drugs Ther 2020 08;62(1604):124-128

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Uterine bleeding with hormone therapies in menopausal women: a systematic review.

Climacteric 2020 12 7;23(6):550-558. Epub 2020 Sep 7.

TherapeuticsMD, Boca Raton, FL, USA.

Uterine bleeding is a common reason why women discontinue menopausal hormone therapy (HT). This systematic review compared bleeding profiles reported in studies for continuous-combined HT approved in North America and Europe for moderate to severe vasomotor symptoms in postmenopausal women with a uterus. Non-head-to-head studies showed that uterine bleeding varies by formulation and administration route, with oral having a better bleeding profile than transdermal formulations. Read More

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December 2020

Breast effects of oral, combined 17β-estradiol, and progesterone capsules in menopausal women: a randomized controlled trial.

Menopause 2020 12;27(12):1388-1395

TherapeuticsMD, Boca Raton, FL.

Objective: To evaluate the effect of a single-capsule, bioidentical 17β-estradiol (E2) and progesterone (P4) hormone therapy on mammograms and breasts in postmenopausal women after 1 year of use.

Methods: In the 12-month, phase 3, randomized, double-blind, placebo-controlled, multicenter REPLENISH trial, postmenopausal women (40-65 y) with moderate to severe vasomotor symptoms and a uterus were randomized to four active daily dose groups of E2/P4 (TX-001HR) or a placebo group. Mammograms were performed and read locally at screening (or ≤6 months before first dose) and at study end using BI-RADS classification. Read More

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December 2020

The effect of bioidentical nanostructured progesterone in the in vitro culture of preantral follicles and oocyte maturation.

Cell Tissue Res 2020 Dec 21;382(3):657-664. Epub 2020 Jul 21.

Postgraduate Biotechnology, Potiguar University/Laureate International Universities, Av. Senador Salgado Filho, 1610, Lagoa Nova, Natal, Rio Grande do Norte, 59056-000, Brazil.

This study evaluated the effects of bioidentical nanostructured progesterone alone or in association with human chorionic gonadotropin (hCG) on the in vitro survival and development of preantral follicles (experiment 1) and oocyte maturation (experiment 2). Bioidentical hormones have a molecular structure identical with that of endogenous hormones; nanostructured substances refer to those reduced to a nanoscale. In experiment 1, fragments of goat ovarian tissue were cultured for 7 days in α-MEM alone or supplemented with nanoprogesterone (MEM + P4) or P4 and hCG (MEM + P4 + hCG). Read More

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December 2020

Transdermal delivery of bioidentical estrogen in menopausal hormone therapy: a clinical review.

Expert Opin Drug Deliv 2020 04 9;17(4):543-549. Epub 2019 Dec 9.

Division of Women's Health Internal Medicine, Mayo Clinic, Scottsdale, AZ, USA.

: The history of menopausal hormone therapy (HT) use has evolved over the years based on the influence of many factors, including availability and safety related to formulation and route of estrogen products. Given unexpected findings from the Women's Health Initiative (WHI) in the early 2000's that used oral conjugated equine estrogen, the desire for and research supporting transdermal estradiol products grew. Transdermal estrogen is now a popular and commonly used formulation for treating menopausal symptoms. Read More

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Hormone Therapy and Effects on Sporadic Alzheimer's Disease in Postmenopausal Women: Importance of Nomenclature.

J Alzheimers Dis 2020 ;73(1):23-37

Austin Health, Heidelberg Repatriation Hospital, Victoria, Australia.

Numerous observational studies have suggested that hormone therapy (HT) might protect postmenopausal women against cognitive decline and Alzheimer's disease (AD). However, because of the significant disparity between results, especially those between observational and randomized controlled trials (RCT), this postulate remains unproven. A significant contributing factor to these inconsistencies is the loose use of the generic definitions of estrogens and progestogens with most studies not delineating the clear differences between non-endogenous and endogenously identical (bioidentical) hormones, their molecular binding affinities and actions, and resultant metabolites. Read More

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The dangers of compounded bioidentical hormone replacement therapy.

Br J Gen Pract 2019 11 31;69(688):540-541. Epub 2019 Oct 31.

Professor of Gynaecology, King's College London; Consultant Gynaecologist, Guy's and St Thomas' NHS Foundation Trust, London, UK.

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November 2019

The role of bioidentical hormone replacement therapy in anti-aging medicine: a review of the literature.

Int J Dermatol 2019 Oct 11. Epub 2019 Oct 11.

Moy-Fincher-Chipps Facial Plastics & Dermatology, Beverly Hills, CA, USA.

The changes in skin and overall appearance that occur with increasing age can be partly attributed to declining hormone levels. While hormonal deficiencies are most commonly associated with postmenopausal females, males are also subject to age-related testosterone decline and may benefit from replacement of deficient hormones. However, great disparities exist between the recommendations of scientific societies and actual use of hormone supplements in aging patients. Read More

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October 2019

Determination of estradiol and progesterone content in capsules and creams from compounding pharmacies.

Menopause 2019 09;26(9):966-971

TherapeuticsMD, Boca Raton, FL.

Objectives: To analytically characterize the doses of estradiol and progesterone found in compounded combined forms of oral capsule and transdermal cream formulations, and determine the consistency of the hormone formulations within a batch.

Methods: Prescriptions for combined estradiol/progesterone capsules (0.5 and 100 mg, respectively) and creams (0. Read More

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September 2019

Colorectal cancer screening.

Authors:

Med Lett Drugs Ther 2019 Jul;61(1575):97-99

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A combined, bioidentical, oral, 17β-estradiol and progesterone capsule for the treatment of moderate to severe vasomotor symptoms due to menopause.

Expert Rev Clin Pharmacol 2019 Aug 22;12(8):729-739. Epub 2019 Jul 22.

b TherapeuticsMD , Boca Raton , FL , USA.

: Many women seek treatment to alleviate menopausal vasomotor symptoms (VMS). Numerous women use combination compounded hormone therapy (CHT) to achieve the benefits of estrogen/progesterone for endometrial protection. TX-001HR is a combination of bioidentical 17β-estradiol (E2) and progesterone (P4) in a single capsule designed for continuous daily use to treat moderate to severe VMS. Read More

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BMS - Consensus statement: Bioidentical HRT.

Authors:
Nick Panay

Post Reprod Health 2019 Jun;25(2):61-63

Chelsea and Westminster Hospital, 369 Fulham Rd, Chelsea, London SW10 9NH, UK.

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Comparative Stability Studies of Different Infliximab and Biosimilar CT-P13 Clinical Solutions by Combined Use of Physicochemical Analytical Techniques and Enzyme-Linked Immunosorbent Assay (ELISA).

BioDrugs 2019 Apr;33(2):193-205

Department of Analytical Chemistry, Sciences Faculty/Biomedical Research Institute ibs.Granada, University of Granada, Fuentenueva Avenue s/n, 18071, Granada, Spain.

Background: There are two products in which infliximab is the active pharmaceutical ingredient. These are Remicade (INF; reference product) and Remsima™/Inflectra™ (CT-P13; infliximab biosimilar). Remsima™/Inflectra™ are bioidentical products. Read More

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Bioidentical hormone therapy in menopause: relevance in dermatology.

Dermatol Online J 2019 Jan 15;25(1). Epub 2019 Jan 15.

Department of Dermatology & Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, Florida.

Hormone replacement therapy has been shown to be effective in alleviating menopausal symptoms. However, its use is controversial owing to potential health risks, such as thromboembolism and cancer. Bioidentical hormone therapy has recently become popular as an alternative to conventional hormone replacement therapy. Read More

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January 2019

Increased Incidence of Endometrial Cancer Following the Women's Health Initiative: An Assessment of Risk Factors.

J Womens Health (Larchmt) 2019 02 28;28(2):237-243. Epub 2018 Nov 28.

4 Department of Obstetrics and Gynecology, New York University School of Medicine , New York, New York.

Background: The Surveillance, Epidemiology, and End Result (SEER) database shows a variable increase in endometrial cancer incidence over time. The objective of this review was to examine published endometrial cancer rates and potential etiologies.

Methods: Endometrial cancer incidence was obtained from the SEER Program database from 1975 through 2014, and a test for trend in incidence was calculated. Read More

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February 2019