Bremelanotide for HSDD — two randomized phase 3 trials
Obstetrics & Gynecology / PubMed
TL;DR
Across two phase 3 trials involving 1,267 women, as-needed bremelanotide improved sexual desire and reduced distress related to low desire compared with placebo.
Two phase 3 · randomized · double-blind · placebo-controlled trials
What was studied
The question.
The efficacy and safety of bremelanotide for acquired generalized hypoactive sexual desire disorder in premenopausal women.
How it was conducted
The study design.
Participants were randomized 1:1 to 1.75 mg subcutaneous bremelanotide as needed or placebo for 24 weeks. The coprimary outcomes measured sexual desire and distress related to low sexual desire.
What it found
Did it actually work?
- Bremelanotide significantly improved sexual-desire scores in both trials.
- It significantly reduced distress associated with low sexual desire.
- Nausea, flushing and headache were more common with bremelanotide.
Why it matters
How to read this result.
These are the pivotal human trials supporting the clinical evidence base for PT-141/bremelanotide and its later approved prescription use.
Keep in mind
What the study does not prove.
- The indication and trial population were specific to premenopausal women with HSDD.
- The results should not be generalized to male sexual performance or broad libido enhancement.
Original source
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