Wessells · Urology 2000 · double-blind placebo-controlled crossover trial · n=10

Effect of an alpha-melanocyte stimulating hormone analog on penile erection and sexual desire in men with organic erectile dysfunction.

Cited 137 times in the scientific literature.

Level 2 - randomized trial

Randomized, double-blind, placebo-controlled crossover clinical trial

PubMed 11018622 · doi:10.1016/s0090-4295(00)00680-4 · record verified 2026-08-27

What was done

Ten men with organic erectile dysfunction participated in a double-blind, placebo-controlled crossover study. Participants received subcutaneous injections of Melanotan II (0.025 mg/kg) twice and vehicle (placebo) twice. Erections were assessed over a 6-hour period using real-time RigiScan monitoring and a visual analog scale. Sexual desire and side effects were evaluated via questionnaires.

What was found

Melanotan II elicited subjectively reported erections in 12 of 19 injections compared to 1 of 21 placebo injections. Among responders, the mean rigidity score was 6.9 out of 10. The mean duration of tip rigidity greater than 80% was 45.3 minutes for Melanotan II versus 1.9 minutes for placebo (P = 0.047). Sexual desire was significantly higher after Melanotan II administration than after placebo. Adverse effects were more frequent with Melanotan II, including stretching/yawning and nausea, with 4 of 19 Melanotan II injections resulting in severe nausea.

Why it matters

This study demonstrates that central melanocortin receptor stimulation with Melanotan II can induce erections and enhance sexual desire in men with organic causes of erectile dysfunction, not just psychogenic cases.

Limits

The study evaluated a very small sample size (n = 10 men), and only acute responses over a single 6-hour period per dose were monitored. Severe nausea occurred in 21% of active treatment administrations, posing tolerability concerns, and long-term efficacy and safety were not examined.

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