Study record · Melanotan II
Evaluation of melanotan-II in a pilot Phase I clinical study
Increased pigmentation was documented in two participants; spontaneous penile erections occurred intermittently after dosing.
Key result
Increased pigmentation was documented in two participants; spontaneous penile erections occurred intermittently after dosing.
Study details
Study designSingle-blind, alternating-day placebo-controlled dose-escalation study
PhasePhase I
PopulationHealthy male volunteers
Sample size3
RouteSubcutaneous
Regimen / exposureStarting 0.01 mg/kg with escalation up to 0.025-0.03 mg/kg on alternating treatment days
Duration2 weeks
ComparatorSaline
Primary endpoint / questionPigmentation, tolerability and unexpected physiological effects
Safety resultMild nausea was common; somnolence/fatigue occurred at 0.03 mg/kg in one participant.
Key limitationsExtremely small early study; not an efficacy trial for cosmetic tanning or sexual dysfunction and not a long-term safety dataset.
Registry / identifierPMID 8637402