Bremelanotide for Treatment of Female Hypoactive Sexual Desire

Hypoactive sexual desire disorder (HSDD) is a persistent deficiency or absence of sexual fantasies and desire resulting in significant distress or interpersonal difficulty. Women with this disorder may display a lack of motivation for sexual activity, reduced responsiveness to erotic cues, a loss of interest during sexual activity, and avoidance of situations that could lead to sexual activity. The pathophysiology of HSDD is thought to be centered around inhibitory and excitatory hormones, neurotransmitters, and specific brain anatomy. Due to the multifactorial nature of HSDD, treatment can be complex and must attempt to target the biological and psychosocial aspects of the disorder. Bremelanotide is a melanocortin receptor agonist and has been recently approved by the FDA to treat HSDD. Bremelanotide is administered intranasally or as a subcutaneous injection. The recommended dosage of bremelanotide is 1.75 mg injected subcutaneously in the abdomen or thigh at least 45 min before sexual activity. Studies showed improvements in desire, arousal, and orgasm scores when 1.75 mg of bremelanotide was administered before sexual activity compared to a placebo. Bremelanotide is a promising way to treat HSDD.

Women and Men’s Perspectives on the Factors Related to Women’s Dyadic Sexual Desire, and on the Treatment of Hypoactive Sexual Desire Disorder

Sexuality is a basic human need, which is expressed in the context of intimate personal relations. However, in studies of women’s sexuality, men’s attitudes are often overlooked. Health care providers can benefit from the examination of how both women and men perceive women’s sexual desire and what are the most acceptable avenues for treatment for women’s hypoactive sexual desire disorder (HSDD). This research aimed to explore differences between women and men on the factors affecting women’s sexual desire and the appropriate avenues for treatment. Data were collected using an online questionnaire from 233 heterosexual adults who had a dyadic, steady intimate relationship over most of the previous year. A theory-based questionnaire of 28 items was developed to explore the factors associated with women’s sexual desire. One quarter (7/28) of the items affecting women’s sexual desire were ranked significantly differently between women and men. Among women, interpersonal issues and physical attraction, and among men, physical attraction and daily hassles were the significant predictors of women’s sexual desire. Women more than men endorsed psychological help such as a sex therapist or psychologist as a more appropriate treatment for HSDD, while both men and women viewed the internet as a reasonable way to gain treatment information. Both women and men viewed gynecologists as a more acceptable source of treatment than a family doctor. Religious authorities were the least likely source of treatment advice for both women and men. The results support a multi-dimensional model of women’s sexual desire and suggest that psychological interventions to treat HSDD may be preferred by women more than men.

Bremelanotide and flibanserin for low sexual desire in women: the fallacy of regulatory precedent

The US Food and Drug Administration (FDA) has approved two drugs for ‘hypoactive sexual desire disorder’ in women, flibanserin (Addyi) in 2015 and bremelanotide (Vyleesi) in 2019. In this paper we examine the outcome measures and clinical trial data upon which regulatory approval was based. In clinical trials, flibanserin led to an average of only one additional enjoyable sexual experience every two months, bremelanotide to none. Trials for both drugs feature shifts in primary outcomes and a contested indication. A politicised industry-sponsored advocacy campaign and conflicted patient and expert testimony likely influenced flibanserin’s approval at its third attempt. Bremelanotide, with even weaker efficacy, capitalised on the regulatory precedent set by the approval of flibanserin. Reconsideration of regulatory decisions to approve these drugs is in order, as well as a broader examination of how future regulatory decisions can better address conflicts of interest and clinically meaningful benefit.

Unconsummated Marriage (“Honeymoon Impotence”): 25 years’ Experience with 871 Couples, in Kermanshah, Iran.

Background: Unconsummated marriage (UCM) is a condition in which the first coitus in a marriage has not occurred in “due time” and thus the bride remains a virgin. UCM, which occurs early in married life, can sometimes last for years and have significant negative effects on a couple’s sexual satisfaction. Here we report our experience with 871 couples in Kermanshah, Iran.Methods: Electronic medical records of couples with UCM, seen by Zargooshi from 1996 to 2021, were reviewed. Some patients whose data were reported in our previous articles at 2000 and 2008, were not included here. For transparency, we voluntarily sent the full identifying data of our patients to the Journal during the first submission of the manuscript.Results: Associated conditions include erectile dysfunction (49.8%), premature ejaculation (14.6%), male hypoactive sexual desire disorder (7.2%), and vaginismus (12.5%). Intracavernosal injection (ICI) was used as the treatment of choice. The consummation rate was 95.1%. We used ICI in presence of vaginismus, too. It may appear “ungentle” to approach the vaginismus this way. However, the couples preferred this expeditious treatment over a time-consuming, and ineffective alternative.Conclusions: In most cases, UCM is due to psychogenic ED, for which ICI (not psychological interventions) is the best treatment because the typical couples who present with UCM are noncompliant with time-consuming treatments. Therefore, the most effective treatment was intracavernosal injection and then the administration of type 5 phosphodiesterase drugs and the most ineffective treatment was psychological counseling.

The Role of Testosterone in Menopause Management: A Review of Literature

Background: Despite the lack of approved testosterone formulations for women in most countries, testosterone therapy is still being offered to women worldwide. Aging and loss of ovarian or adrenal function, among others, can lower testosterone levels in women. However, international guidelines currently do not routinely recommend androgen replacement therapy due to lack of long-term safety data. Evidence on its benefits and risks still remains uncertain. Objectives: The aim of this literature review is to present current studies and guidelines that examined the effects of testosterone therapy for postmenopausal women, including its role on cognition and mood; breast and endometrial cancer risks; musculoskeletal, cardiovascular, and genitourinary health; and sexual function. Methodology: A review of literature was done using PubMed, EMBASE, Science Direct, OVID, and Google scholar, with the following key words: androgen, testosterone, menopause, and hypoactive sexual desire dysfunction. We identified reviews, clinical trials, and guidelines. The population was limited to postmenopausal women. Results: There is no evidence from current published literature to support the use of testosterone therapy for female well-being, mood and cognition, bone and cardiovascular health. Intravaginal testosterone appears to be a promising alternative for the treatment of genitourinary symptoms of menopause (GSM) but efficacy and safety are yet to be confirmed. Well-designed, randomized, and placebo-controlled trials are needed to establish long-term safety, efficacy, and appropriate dosing and route of testosterone therapy in postmenopausal women. The only evidence-based indication for testosterone therapy in women is for the treatment of postmenopausal hypoactive sexual desire disorder (HSDD). Should a trial of testosterone therapy be given for HSDD, the transdermal route is the preferred method of delivery. Baseline total testosterone concentration should be determined before starting treatment, and repeated after 3–6 months. Serum testosterone levels should be monitored at regular intervals to avoid supraphysiologic dosing. Conclusion: Currently, there is no robust evidence to support the use of exogenous testosterone to improve female well-being, musculoskeletal health, mood and cognition, as well as bone and cardiovascular health among postmenopausal women. The only evidence-based indication for testosterone therapy in women is the treatment of postmenopausal hypoactive sexual desire disorder, but only after all other causes of sexual dysfunction have been ruled out. To date, testosterone therapy has no US Food and Drug Administration (US FDA) approval due to the lack of long-term efficacy and safety data.

There is insufficient evidence to recommend bremelanotide for hypoactive sexual desire disorder

An informed consent discussion for a patient with Hypoactive Sexual Desire Disorder.