Salvage of sildenafil failures with bremelanotide: a randomized, double-blind, placebo controlled study.
Safarinejad. Mohammad Reza MR; Hosseini. Seyyed Yousof SY
Key Findings
- 33.5% of men using 10 mg intranasal bremelanotide reported successful erections versus 8.5% on placebo (p = 0.03).
- Intercourse satisfaction scores were significantly higher in the bremelanotide group (p = 0.03).
- Drug‑related adverse effects were more common with bremelanotide (p = 0.01).
Practical Outcomes
- Bremelanotide can be tried as an alternative for men who don’t respond to sildenafil, using a 10 mg nasal spray taken 45 min–2 h before sex. Expect a modest chance of improvement (roughly 1 in 3) but be prepared for higher rates of side effects such as nasal irritation or headache. More research on dosing is needed, so start low, monitor response, and adjust cautiously.
Summary
A study gave men who didn't work with Viagra a nasal spray of bremelanotide (pt-141). About one‑third of the men saw improvement in erections, compared to less than 10% on placebo. The drug also boosted sexual satisfaction but caused more side effects.
Abstract
We evaluated the safety and efficacy of intranasal bremelanotide in men with erectile dysfunction who did not respond to sildenafil. A total of 342 married men (28 to 59 years old) with erectile dysfunction who did not respond to sildenafil were randomly assigned to receive 10 mg bremelanotide as an intranasal spray (group 1, 172) 45 minutes to 2 hours prior to sexual stimulation, or a similar regimen of placebo (group 2, 170). Patients were asked to use at least 16 doses/attempts at home. They underwent preliminary assessment, including medical and sexual history, and self-administered International Index of Erectile Function. The efficacy of 2 treatments was assessed every 4 attempts during treatment and at the end of study, using responses to International Index of Erectile Function, and evaluation of mean intercourse satisfaction domain, mean weekly coitus episodes and adverse drug effects. Positive clinical results were seen in 51 (33.5%) patients in the bremelanotide group compared with 13 (8.5%) patients in the placebo group (p = 0.03). Patients in the bremelanotide group reported significantly greater intercourse satisfaction than those in placebo group (p = 0.03). More drug related adverse effects occurred in the bremelanotide group (p = 0.01). Bremelanotide can be an alternative treatment for erectile dysfunction with a potentially broad patient base. Further studies with different dosages and treatment regimens are necessary to draw final conclusions on the efficacy of this drug in erectile dysfunction.
Study Information
pubmed
2008
2008-01-18T00:00:00.000Z
10.1016/j.juro.2007.10.063
54
18