Human evidence record · Melanotan II

Melanotan II in men with organic erectile dysfunction

Subjective erections occurred after 12/19 active injections versus 1/21 placebo doses; desire was higher after Melanotan II.

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Human evidence record

What this study tells us

This study compared groups, which is more informative than an uncontrolled report. The amount of confidence still depends on how the groups were formed, how outcomes were measured and how well bias was controlled.

Who was studied?

Men with organic erectile dysfunction

How many?

n=10

What happened?

Subjective erections occurred after 12/19 active injections versus 1/21 placebo doses; desire was higher after Melanotan II.

What stops us overclaiming?

Small acute study; no long-term efficacy/safety and not an approved ED therapy.

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Key result

Subjective erections occurred after 12/19 active injections versus 1/21 placebo doses; desire was higher after Melanotan II.

Study details

Study designDouble-blind, placebo-controlled crossover study

PopulationMen with organic erectile dysfunction

Sample size10

RouteSubcutaneous

Regimen / exposure0.025 mg/kg Melanotan II; each participant received active and placebo exposures

DurationAcute 6-hour monitoring

ComparatorVehicle placebo

Primary endpoint / questionErectile response, rigidity, sexual desire and adverse effects

Safety resultNausea and stretching/yawning were more frequent; 4/19 active injections were associated with severe nausea.

Key limitationsSmall acute study; no long-term efficacy/safety and not an approved ED therapy.

Registry / identifierPMID 11018622

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