Study record · Bremelanotide
Bremelanotide in men with erectile dysfunction unresponsive to sildenafil
Positive clinical results occurred in 33.5% with bremelanotide versus 8.5% placebo; intercourse satisfaction was greater.
Key result
Positive clinical results occurred in 33.5% with bremelanotide versus 8.5% placebo; intercourse satisfaction was greater.
Study details
Study designRandomized, double-blind, placebo-controlled study
PopulationMen with erectile dysfunction who had not responded to sildenafil
Sample size342
RouteIntranasal
Regimen / exposure10 mg intranasal bremelanotide before sexual stimulation
DurationAt least 16 home-use attempts
ComparatorPlacebo
Primary endpoint / questionClinical erectile response and intercourse satisfaction
Safety resultDrug-related adverse effects occurred more frequently with bremelanotide.
Key limitationsOlder intranasal formulation; current U.S. approval is subcutaneous and specifically not indicated for men.
Registry / identifierPMID 18206919