Salvage of sildenafil failures with bremelanotide: a randomized, double-blind, placebo controlled study

Summary

Randomized, double-blind, placebo-controlled trial of intranasal bremelanotide (PT-141) in 342 married men aged 28–59 with erectile dysfunction (ED) who had not responded to sildenafil. Men used a 10 mg bremelanotide nasal spray or matching placebo 45 minutes to 2 hours before sexual stimulation, for at least 16 doses/attempts at home. In January 2023 The Journal of Urology published an expression of concern about this article (PMID 36626345). PubMed does not state the reason, so the results below should be read with caution.

Key Findings

• 172 men were randomized to bremelanotide and 170 to placebo
• Positive clinical results were reported in 51 (33.5%) men on bremelanotide vs 13 (8.5%) on placebo (p = 0.03)
• The bremelanotide group reported significantly greater intercourse satisfaction than the placebo group (p = 0.03)
• Drug-related adverse effects were more frequent with bremelanotide (p = 0.01)
• The authors conclude bremelanotide could be an alternative ED treatment, but say studies of other doses and regimens are needed before final conclusions

Methodology

Randomized, double-blind, placebo-controlled parallel-group trial by researchers at the Urology and Nephrology Research Center, Shaheed Beheshti University of Medical Sciences, Tehran, Iran. Participants completed a medical and sexual history and the self-administered International Index of Erectile Function (IIEF) at baseline. Efficacy was assessed every 4 attempts and at the end of the study using IIEF responses, the intercourse satisfaction domain, mean weekly coitus episodes and adverse drug effects.

Limitations

• The journal has published an expression of concern about this article (2023)
• The reported percentages (33.5%, 8.5%) do not match the randomized group sizes (172, 170), and the abstract does not state the denominator used
• Only one dose and route (10 mg intranasal) was tested
• Limited to men who had not responded to sildenafil, not a general ED population
• The abstract does not report treatment duration in weeks or longer-term safety

Relevance to Content

A randomized placebo-controlled trial of PT-141 specifically in men with ED, including men who had not responded to sildenafil. Useful context for male-use content, but the journal’s expression of concern means it should not be presented as settled evidence.

See Also

• Parent compound: PT-141