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pt-141 melanocortin agonist rct n=327 2026-04-03 PubMed

Bremelanotide Safely Boosts Sexual Desire and Function in Premenopausal Women

Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial.

Background

Many premenopausal women experience Female Sexual Dysfunctions (FSD), characterized by low sexual desire, arousal difficulties, or inability to achieve orgasm, significantly impacting their quality of life. Despite its prevalence, effective and on-demand pharmacological treatments for FSD, particularly those related to desire and arousal, have been limited. This study aimed to evaluate the efficacy and safety of bremelanotide (BMT) as a novel treatment for FSD in this population.

Results

Efficacy data from 327 participants demonstrated significant improvements in sexual function and reduced distress with bremelanotide. For the pooled 1.25 mg and 1.75 mg bremelanotide groups compared to placebo, the mean change from baseline to study end showed a substantial increase in satisfying sexual events. Patients treated with bremelanotide experienced an average increase of +0.7 satisfying sexual events per month, significantly higher than the +0.2 increase observed in the placebo group (p=0.0180). Furthermore, the bremelanotide groups showed a mean increase of +3.6 in the Female Sexual Function Index (FSFI) total score, compared to +1.9 for placebo (p=0.0017), indicating improved overall sexual function. Sexual distress was also significantly reduced, with a mean decrease of -11.1 in the Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) total score for bremelanotide, versus -6.8 for placebo (p=0.0014). The most common adverse events reported were nausea, flushing, and headache, consistent with previous studies, and generally well-tolerated.

Why It Matters

This study provides strong evidence that bremelanotide is a safe, effective, and well-tolerated treatment for female sexual dysfunctions in premenopausal women. The significant improvements in satisfying sexual events, overall sexual function, and reduction in sexual distress highlight its potential as a valuable therapeutic option. Given its self-administered, on-demand subcutaneous delivery, bremelanotide offers a convenient and accessible treatment modality that could significantly improve the lives of women struggling with FSD. These positive dose-finding results paved the way for larger Phase III clinical trials and ultimately, regulatory approval, offering a new hope for a condition with limited pharmacological interventions.


pt-141 melanocortin agonist dose mentioned protocol relevant safety data present
Source: pubmed:27181790 · Ingested 2026-04-03 · Digest: gemini-2.5-flash