Safety and Efficacy of a Testosterone Patch for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women
Glenn D. BraunsteinDale A. SundwallMolly KatzJan L. ShifrenJohn E. BusterJames A. SimonGloria A. BachmanOscar AguirreJohna LucasCynthia RodenbergAkshay BuchNelson B. Watts
456
Citation
22
Reference
10
Related Paper
Citation Trend
Abstract:
Oophorectomy reduces serum testosterone levels. We studied the efficacy and safety of transdermal testosterone in treating hypoactive sexual desire disorder in surgically menopausal women.A 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter trial was conducted in women (aged 24-70 years) who developed distressful low sexual desire after bilateral salpingo-oophorectomy and hysterectomy and who were receiving oral estrogen therapy. Women were randomized to receive placebo (n = 119) or testosterone patches in dosages of 150 microg/d (n = 107), 300 microg/d (n = 110), or 450 microg/d (n = 111) twice weekly for 24 weeks. Sexual desire and frequency of satisfying sexual activity were primary efficacy outcome measures.Of the 447 women randomized, 318 (71%) completed the trial. Compared with placebo, women receiving the 300-microg/d testosterone patch had significantly greater increases from baseline in sexual desire (67% vs 48%; P = .05) and in frequency of satisfying sexual activity (79% vs 43%; P = .049). The 150-microg/d group showed no evidence of a treatment effect. The 450-microg/d group also was not statistically different from the 300-microg/d or placebo groups. Marginally significant linear dose-response trends were observed for total satisfying sexual activity and sexual desire at 24 weeks (P = .06 and .06, respectively). Adverse events occurred with similar frequency in both groups; no serious safety concerns were observed.The 300-microg/d testosterone patch increased sexual desire and frequency of satisfying sexual activity and was well tolerated in women who developed hypoactive sexual desire disorder after surgical menopause.Keywords:
Transdermal patch
Dose
Bremelanotide has been available off-label through compounding pharmacies for many years for men and women seeking to improve libido. In 2019, the FDA approved use of bremelanotide (Vyleesi) for premenopausal women with hypoactive sexual desire disorder (HSDD), the second medication approved for this purpose.
Compounding
Cite
Citations (0)
The sex therapy literature has concentrated on disorders of the excitement and orgasm phases of the sexual response. However, disorders of sexual desire have been virtually neglected, although low-libido disorders are highly prevalent, may be extremely distressful to patients and their partners, and influence the course and prognosis of therapy. This paper focuses on this important aspect of human sexuality. Some clinical features of hypoactive sexual desire are described, and some hypotheses about etiology and prognosis are presented.
Orgasm
Sex therapy
Etiology
Cite
Citations (358)
In recent decades, women are increasingly contact the doctors with problems of hypoactive sexual desire disorders (HSDD). Female libido is considered as one of the important indicators of quality of life, sexual health. Therapy of HSDD is difficult due to insufficient knowledge by doctors of both complex, multiple pathogenetic mechanisms of libido reduction and modern therapeutic approaches. In this article, the female sexual desire is considered from the point of view of the biopsychosocial approach, recognized as the leading one when working with sexual dysfunctions. According to biopsychosocial approach, HSDD is a consequence of combined disorders at various levels of human functioning (somatic, personal-psychological and individual-social). Modern conceptual models of sexual desire are presented, on the basis of which therapeutic approaches to HSDD are developed. The most effective from the evidence point of view directions of therapy of HSDD in women – elimination of biomedical factors that violate libido, psychotherapeutic measures (sexual awareness, cognitive behavioral therapy, sexual therapy) are discussed. Evidence-based studies confirming the high effectiveness of an integrative approach to the therapy of HSDD, combining sexual awareness, CBT, sexual therapy and pharmacotherapy, are presented. A new Russian drug – a peptide created specifically for the treatment of HSDD in women is presented. The drug has passed all stages of clinical trials and can be used both in the treatment of idiopathic HSDD and as part of combine therapy (in combination with psychotherapy and sextherapy).
Biopsychosocial model
Cite
Citations (1)
hirsutism
Cite
Citations (23)
Female sexual dysfunction
Premenstrual dysphoric disorder
Cite
Citations (1)
Cite
Citations (0)
Low sexual desire is a prevalent symptom, but not one frequently volunteered by women. When accompanied by distress, loss of libido is known as hypoactive sexual desire disorder, which can have a significant impact on a woman's wellbeing. The etiology of hypoactive sexual desire disorder is multifactorial and its management requires a combination of psychosocial and pharmacological interventions. This article outlines the assessment of patients presenting with the symptom of low sexual desire and discusses the evidence for pharmacological management.
Etiology
Cite
Citations (14)
Cite
Citations (0)
Cite
Citations (4)
Female sexual dysfunction is a common, multifactorial medical condition, which can have a major impact on self-esteem, quality of life, mood and relationships. Hormonal imbalances may contribute to sexual dysfunction, in particular sexual arousal disorder. Androgens for the treatment of decreased libido, especially in postmenopausal women, have gained increased popularity despite preliminary and controversial results. The absence of precise definitions of androgen deficiency, unknown 'normal' ranges for androgens, and nuances in the sensitivity of the various assays have made research on androgens and libido in women difficult to interpret. This review presents the role of estrogen and androgens in sexual function and their potential roles as therapeutic agents for female sexual dysfunction.
Cite
Citations (28)