What the studies show
RECONNECT studies, 24 weeks: FSFI desire-domain change +0.5 to +0.6 vs +0.2 on placebo. Statistically significant, clinically modest.
Several well-run randomised trials in people, pointing the same way. You can plan around this. It still says nothing about whether the effect is worth the side effects for you.
- 1VYLEESI (bremelanotide injection) US prescribing information — RECONNECT phase 3 studies (NCT02333071, NCT02338960).FDA label, initial US approval 20191,267 premenopausal women across two 24-week trials; efficacy and adverse-event figures on this page come from the label.
In context
PT-141, sold as Vyleesi, is a melanocortin-receptor agonist approved in the United States in 2019 for premenopausal women with hypoactive sexual desire disorder. Two phase 3 trials in 1,267 women found statistically significant but small improvements in desire and distress scores against placebo. Nausea affected 40% of participants and 18% stopped because of side effects. Use in men, and for erectile function, is unapproved and far less studied.
PT-141 is approved (rx, us). Legal status differs by country — see the regulation section or the jurisdiction pages.
Questions
Is PT-141 proven to help with sexual desire?
What studies are behind the grade?
Is PT-141 approved for this?
Other outcomes for PT-141
- ASexual distress (same population)2 phase 3 RCTs
- CErectile function / use in menEarlier phase 2 work
- ANauseaadversePhase 3
- AFlushing and headacheadversePhase 3
Reviewed 2 September 2026. Grades count human evidence only; see how LYO grades. Not medical advice. Correct this page →