You have read that Vyleesi, the FDA-approved bremelanotide autoinjector for low sexual desire, “works” for premenopausal women. Then a research site sells PT-141, the same molecule, and you wonder a simpler thing: in the big trials, did the women who tried it actually want to keep using it?
The answer depends on who read the data. A survey run with the drug’s developers found that women on bremelanotide described more desire and arousal. A 2021 reanalysis by an outside psychologist found that women on the drug were far more likely to quit because of side effects, and less likely than women on placebo to finish and sign up for more.
What the exit survey found
The two RECONNECT phase 3 trials (NCT02333071 and NCT02338960) ran for 24 weeks. Before moving into an open-label extension, women were invited to an exit survey while still blinded. Koochaki and colleagues, writing in the Journal of Women’s Health in 2021, reported that 242 women completed the survey and 80 also did phone interviews.
Women who had received bremelanotide described feeling more sexual desire, more physical arousal, and better quality of sexual activity with a partner. Women on placebo also reported benefits, but of a different kind: feeling good about seeking help and talking more with their partner. Authors on the paper worked for Palatin Technologies and AMAG Pharmaceuticals, the companies behind the drug, and for contract research firms.
What the reanalysis found
Glen Spielmans of Metropolitan State University went back to the trial protocols and the FDA application data and published his reading in the Journal of Sex Research. He found that about 73 percent of the outcomes listed in the protocols were not reported in the main published paper, while 15 secondary measures that were reported had not been listed in the protocols.
His pooled analysis matched the published efficacy results in direction. Two findings stood out. The odds of leaving the study because of an adverse event were about 12 times higher on bremelanotide, roughly one extra dropout for every six women treated. And when he counted women who both finished the trial and chose to continue in the open-label phase, placebo came out ahead, with an odds ratio of 0.30 for bremelanotide. His conclusion was that the drug’s modest benefits, measured on outcomes of uncertain validity, make it “generally not useful.”
Reading both papers together
These papers measure different things. The exit survey captures how women who stayed to the end described their experience. The reanalysis counts who left and who chose to keep going. A treatment can feel meaningful to some users while also driving many others away, especially when nausea, flushing, and headache are common, as the Vyleesi label describes.
Neither paper tested research-grade PT-141. The trials used a regulated product with manufacturing controls and prescriber screening, including blood pressure checks. A vial sold “for research use” carries none of that evidence or oversight.
If low desire is causing you distress, the more useful question for a clinician is not “does it work” but “how likely am I to tolerate it, and what else could help first?” Ask about side effect rates, blood pressure, and alternatives such as addressing medications, relationship strain, or depression. Expect real but modest effects, and know that many trial volunteers decided it was not worth continuing. Not medical advice.
Sources
- Spielmans GI. Re-analyzing phase III bremelanotide trials for “hypoactive sexual desire disorder” in women. J Sex Res, 2021 (PubMed)
- Koochaki P et al. The patient experience of premenopausal women treated with bremelanotide for HSDD: RECONNECT exit study results. J Womens Health, 2021 (PubMed)
- DailyMed: Vyleesi (bremelanotide) prescribing information
Related reading
- Nausea and blood pressure tradeoffs with Vyleesi
- Why a PT-141 listing does not carry the Vyleesi evidence
- PT-141 studies in men after Viagra failed
By The Everyday Brief. AI-assisted drafting with automated source and editorial checks. Sources fetched 2026-10-22 PT. Not medical advice.