Human evidence record · Bremelanotide

RECONNECT Phase III trials of bremelanotide for HSDD

Bremelanotide significantly improved validated desire and distress endpoints versus placebo.

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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?

Premenopausal women with acquired, generalized HSDD

How many?

n=1267

What happened?

Bremelanotide significantly improved validated desire and distress endpoints versus placebo.

What stops us overclaiming?

Indication-specific population; results do not establish general libido/performance enhancement in other populations.

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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

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