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Human evidence record ยท 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.

Quick read
Human evidence record

What this study tells us

Participants were assigned to comparison groups by chance, usually with placebo and/or blinding to reduce bias. This is a strong design for testing cause and effect, but the population, duration and endpoints still limit what can be concluded.

Who was studied?

Men with erectile dysfunction who had not responded to sildenafil

How many?

n=342

What happened?

Positive clinical results occurred in 33.5% with bremelanotide versus 8.5% placebo; intercourse satisfaction was greater.

What stops us overclaiming?

Older intranasal formulation; current U.S. approval is subcutaneous and specifically not indicated for men.

Need help with terms such as randomized, placebo, endpoint or sample size? Open the glossary โ†’

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