Publications by authors named "Amber N McLendon"

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.

Data Synthesis: In 1 phase 3 clinical study, 17β-E/P was proven to be effective at reducing the frequency and severity of vasomotor symptoms (VMS) at 12 weeks compared with placebo, and no cases of endometrial hyperplasia were observed over the 52-week safety study period. Menopausal women with an intact uterus were included in the study population.

Relevance To Patient Care And Practice: Concerns over content and safety of compounded bioidentical hormones have been raised by several professional societies. As women experience VMS of menopause, a desire for a Food and Drug Administration-regulated bioidentical combination product for the treatment of moderate to severe menopausal symptoms may be desirable. Given as a once-daily oral capsule at the dose of 1 mg estradiol/100 mg progesterone, 17β-E/P is approved for the treatment of VMS associated with menopause.

Conclusions: 17β-E/P is a novel bioidentical product that is the first of its kind in the treatment of moderate to severe menopausal symptoms.

Vulvovaginal atrophy (VVA) and dyspareunia are common problems experienced by postmenopausal women, although few seek treatment. Symptom-based therapies include nonhormonal vaginal lubricants, vaginal moisturizers, low-dose vaginal estrogen, and systemic estrogen. The 2013 United States Food and Drug Administration approval of ospemifene, an estrogen agonist/antagonist for the treatment of moderate-to-severe dyspareunia associated with VVA, increased options available to women. Several studies have evaluated the effects of ospemifene on VVA and dyspareunia and indicate an improvement in subjective findings. Objective findings such as a decrease in pH and recovery of a premenopausal vaginal maturation index have been reported. Beneficial effects have also been demonstrated in bone. Evaluations of breast health support the safety of ospemifene, although data are limited to 1 year. Short-term risks appear to be limited and include the development of hot flushes. Until additional comparative studies of ospemifene and estrogens have been performed, ospemifene should be recommended for women with symptoms of VVA and dyspareunia who are unable to tolerate or unwilling to take local or systemic estrogens. In this review, current evidence for the safety and efficacy of ospemifene in the treatment of moderate-to-severe VVA and dyspareunia are evaluated.

The purpose of this review is to describe the available evidence for osteoporosis treatments in young and premenopausal women. A review of articles evaluating the treatment or prevention of osteoporosis in young (age less than 50 years) or premenopausal women was conducted. Several trials evaluating the treatment of anorexia nervosa and use of hormone therapy in those women, the use of bisphosphonates in women undergoing chemotherapy for breast cancer and the use of bisphosphonates, teriparatide and vitamin D in women with glucocorticoid-induced osteoporosis are described. Limited data were found to support the treatment of osteoporosis in women with idiopathic osteoporosis or cystic fibrosis, or after kidney transplant. The evidence for treatment of osteoporosis in premenopausal women is not nearly as robust as that for postmenopausal osteoporosis. Although fracture risk in the premenopausal population is low, women with secondary osteoporosis may benefit from treatment with various agents, depending upon the condition.

Objectives: To evaluate the prevalence, associated factors, and opinions regarding nonmedical use of prescription stimulants (NMUPS) in Doctor of Pharmacy (PharmD) students.

Methods: An electronic survey was distributed to professional year 1 through 4 for students at 2 schools of pharmacy (public and private) in North Carolina. The survey was available for 3 weeks. Descriptive statistics (proportion of responders plus 95% confidence intervals [CIs]) were used to describe the primary objective.

Results: Of the 1043 surveys distributed, 407 were completed giving a 39% response rate. The results indicated that 9% (95% CI: 6.44-11.93) of PharmD students acknowledge NMUPS at least once during their pharmacy education. Additionally, 3% (95% CI: 1.90-5.45) acknowledge NMUPS at least once during the current pharmacy school year (past 5 months). Nonmedical prescription stimulant users were 9 times more likely to participate in NMUPS prior to pharmacy school (P < .0001) and 4.5 times more likely to use other illicit substances (P = .0076).

Conclusion: The study identified the PharmD student population as high risk of abuse of prescription drug stimulants, which requires further research and attention. Additionally, there was a clear upward trend in the prevalence of NMUPS, and this misuse was associated with other detrimental behaviors.

Over 50% of women are believed to be affected by female sexual dysfunction (FSD). When particularly distressful, FSD is known as hypoactive sexual desire disorder (HSDD). In contrast to male sexual dysfunction that has been extensively researched, there is less evidence addressing the treatment of HSDD in women, particularly with regard to the use of androgen therapy. A variety of testosterone products, including oral, injectable, and transdermal preparations, has been prescribed for the treatment of HSDD in premenopausal women, as well as in those with naturally occurring or surgically induced menopause. Although studies have shown some benefit with testosterone supplementation in women with HSDD, conflicting evidence and debate regarding the clinical efficacy of testosterone remain. Because of concern over potential adverse events, additional studies with longer follow-up periods are necessary before use of testosterone in women with HSDD becomes widespread. Initiation of testosterone therapy must be considered on an individual basis after a thorough discussion with the patient about risks and benefits.