RECONNECT Study 1: Bremelanotide in Premenopausal Women With HSDD
One of two identically designed pivotal Phase 3 trials for bremelanotide (sold in research form as PT-141), which led to its 2019 FDA approval as Vyleesi for hypoactive sexual desire disorder (HSDD) in premenopausal women. The companion trial, RECONNECT Study 2 (NCT02338960), enrolled a further 714 participants under the same protocol.
Randomized, double-blind, placebo-controlled, multicenter, Phase 3
723 premenopausal women with HSDD
Bremelanotide 1.75mg subcutaneous, self-administered as needed via autoinjector, for 24 weeks, vs. placebo
What the registry says
Status: Completed, June 2017. Results module confirms a completed Phase 3 trial of 723 participants with posted results.
What published research found
Kingsberg et al., Obstetrics & Gynecology, 2019: both RECONNECT trials met co-primary endpoints of improved sexual desire and reduced distress — but a clinically meaningful response was seen in roughly 25–30% of treated participants versus placebo, not the majority. Nausea was the most common side effect, in around 40% of the treatment group.
What This Trial Tells Us
- Real, controlled, peer-reviewed, Phase 3 evidence supporting an FDA-approved use for bremelanotide in a specific population and indication.
- The effect size was real but modest — a clinically meaningful response in roughly a quarter to a third of treated participants above placebo, not a near-universal effect.
What It Does NOT Tell Us
- Nothing about men, or about any use outside premenopausal women with clinically diagnosed HSDD — a different population to anyone using it outside this exact context.
- The modest responder rate means this is not evidence of a strong or universal effect — most participants did not show a clinically meaningful response.
- No UK/MHRA approval exists for this compound — worth checking local regulatory status rather than assuming US approval transfers directly.