Study record · Bremelanotide
RECONNECT Phase III trials of bremelanotide for HSDD
Bremelanotide significantly improved validated desire and distress endpoints versus placebo.
Key result
Bremelanotide significantly improved validated desire and distress endpoints versus placebo.
Study details
Study designTwo randomized double-blind placebo-controlled trials
PhasePhase III
PopulationPremenopausal women with acquired, generalized HSDD
Sample size1267
RouteSubcutaneous
Regimen / exposure1.75 mg as needed before anticipated sexual activity
Duration24 weeks
ComparatorPlacebo
Primary endpoint / questionSexual desire and distress
Safety resultNausea, flushing and headache were common; blood-pressure effects and hyperpigmentation are important label risks.
Key limitationsIndication-specific population; results do not establish general libido/performance enhancement in other populations.
Registry / identifierPMID 31599840