(235) Use of Bremelanotide (Vyleesi) in Men with Sexual Dysfunctions
Authors: Goldstein S , Goldstein I 
Published: February 2024

Abstract

Introduction
Bremelanotide (Vyleesi) is an FDA approved medication for the safe and efficacious treatment of hypoactive sexual desire disorder in premenopausal women, however phase 3 trials revealed it improved arousal and orgasm as well. As a centrally acting drug it was expected to be effective to treat sexual dysfunctions in men and has been prescribed off label routinely in our practice.

Objective
The primary aim of this study was to evaluate the use of bremelanotide in men with various sexual dysfunctions, the reasons why the medication was prescribed, improvements in sexual function and overall satisfaction, and side effects experienced.

Methods
This one-group study design involved men from a single clinic with various sexual dysfunctions prescribed bremelanotide beginning May 1, 2021. After signing consent participants answered the Quality of Life (QOL) Dimension of Sexual Quality of Life Questionnaire, the Patient Global Impression of Improvement (PGI-I) and the General Assessment Questions (GAQ) online. After confirming they had used the medication at least twice, participants completed a structured interview over the telephone with a single interviewer. Descriptive statistics were used to characterize the study cohort. Adverse events were collected.

Results
To date a total of 21 men signed consent and 19 completed the online questionnaires. 80% of these men were more satisfied with their lovemaking and duration of lovemaking; 93% reported vaginal insertion was easier and 71% said it was easier to orgasm. With regard to feelings about initiating lovemaking, 86% were more at ease and 79% anticipated it would be more pleasurable and more carefree. 69% believed orgasm was more pleasurable and 73% said that lovemaking was more pleasurable while 79% reported that the partner’s overall experience was more pleasurable. Using the PGI-I, 53% of participants felt that sexual function after using bremelanotide was a little better, much better, or very much better. Additional questions online revealed similar results. Twelve men completed the one-on-one interview: 69% of participants were prescribed bremelanotide for erectile dysfunction. 64% had at least other one sexual health issue, including anxiety about sex (54%), low sexual desire (45%), not enjoying sex (36%), orgasm difficulties (18%), and ejaculation difficulties and sensation loss (9% each). A total of 91% experienced improvements in sexual function, all with improved erectile function. 100% of those with complaints of low sexual desire and/or complaints of anxiety around sex reported improvement; 64% had decreased anxiety around sex; 55% had more enjoyment with sex; and orgasm improved for 36% of participants. Men reported longer erection and ability for additional erection for 18-24 hours after bremelanotide injection, better connection between genitals and brain, improved sensitivity, and increased confidence. Side effects included flushing (36%), nausea (36%), headache (27%), bothersome spontaneous erections without sexual stimulation for about 24 hours after injection (27%), and incontinence, cramping and abdominal burning (9% each). All adverse events were transient.

Conclusions
While bremelanotide is approved for hypoactive sexual desire disorder in premenopausal women, it has been prescribed and used successfully for men with erectile dysfunction and other concomitant sexual health issues.

Disclosure
Yes, this is sponsored by industry/sponsor: Palatin Technologies.
Clarification: Industry funding only - investigator initiated and executed study.
Any of the authors act as a consultant, employee or shareholder of an industry for: Palatin Technologies.