# PT-141 study findings: what the phase 3 trials measured and found Updated 2026-10-16. The main human evidence for PT-141 comes from two matching phase 3 trials, NCT02333071 and NCT02338960, called RECONNECT. They randomised 1,267 premenopausal women with hypoactive sexual desire disorder to bremelanotide or placebo. Across both trials, desire scores rose 0.35 points more than placebo and distress scores fell 0.33 points more (P < 0.001). More women left the bremelanotide group early. | | | | --- | --- | | Trial names | RECONNECT Study 1 and Study 2 (Kingsberg et al., Obstetrics & Gynecology, 2019) | | Registry numbers | [NCT02333071](https://clinicaltrials.gov/study/NCT02333071) and [NCT02338960](https://clinicaltrials.gov/study/NCT02338960) | | Design | Phase 3, randomised, double-blind, placebo-controlled, 24 weeks (FDA label, 2019) | | Participants | 1,267 premenopausal women with acquired, generalised hypoactive sexual desire disorder randomised; 1,247 in the safety group (Kingsberg et al., 2019) | | Co-primary endpoints | Female Sexual Function Index desire domain; Female Sexual Distress Scale item 13 (Kingsberg et al., 2019) | | Integrated difference from placebo, desire score | +0.35 points, P < 0.001 (Kingsberg et al., 2019) | | Integrated difference from placebo, distress item | −0.33 points, P < 0.001 (Kingsberg et al., 2019) | | Funding | Palatin Technologies, Inc., and AMAG Pharmaceuticals, Inc. (Kingsberg et al., 2019) | | Drugs@FDA label | [FDA label for NDA 210557, 2019](https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210557s000lbl.pdf) | A number from a trial only means something once you know what it counts. A 10-point drop in blood pressure and a 10-point drop on a questionnaire are very different things. The PT-141 trials counted answers on short questionnaires. This page walks through them one step at a time, and it belongs to [the PT-141 hub](/learn/pt-141). The limits come early, because they decide how far the results reach. [What PT-141 is](/learn/pt-141/what-is-pt-141) and [how it works](/learn/pt-141/how-pt-141-works) cover the molecule and the receptors. ## What did the PT-141 phase 3 trials test? The two RECONNECT trials compared bremelanotide with placebo, a dummy treatment, for 24 weeks. They enrolled premenopausal women with acquired, generalised hypoactive sexual desire disorder (HSDD) that had lasted at least six months. Women were randomised 1:1, like a coin toss, and neither the women nor the researchers knew who received which treatment. Of the 1,267 women randomised, 1,247 were in the safety group and 1,202 in the modified intent-to-treat efficacy group. Most were white (85.6%), 96.6% came from US sites, and the average age was 39 years. Modified intent-to-treat means the analysis counted women who were randomised, took the study treatment at least once and had at least one follow-up visit during the double-blind period. The women had had HSDD for about four years on average. The registry records are [NCT02333071](https://clinicaltrials.gov/study/NCT02333071) and [NCT02338960](https://clinicaltrials.gov/study/NCT02338960). ## What did the PT-141 trials measure? The PT-141 trials measured two questionnaire scores. These were co-primary endpoints, meaning both had to be met. The first was the desire part of the Female Sexual Function Index (FSFI). It uses two questions on how often and how strongly a woman feels desire or interest, scored from 1.2 to 6. The second was item 13 of the Female Sexual Distress Scale–Desire/Arousal/Orgasm (FSDS-DAO). It asks how often a woman felt bothered by low sexual desire, scored from 0 to 4. The trials also counted satisfying sexual events as a secondary endpoint, a less central outcome. The number of satisfying sexual events did not differ significantly between the groups. The desire questions ask about the past four weeks. The distress item asks about the past 30 days. A questionnaire point and an event count are separate outcomes. ## What did the PT-141 trials find? Both PT-141 trials found a statistically significant difference from placebo on both scores. Statistically significant means the gap was unlikely to come from chance alone. Across the two studies combined, the desire score rose 0.35 points more than placebo and the distress item fell 0.33 points more, both with P < 0.001. In Study 1 the average desire score change was 0.5 against 0.2 for placebo. In Study 2 it was 0.6 against 0.2. These are points on short scales. A group average does not predict how any one person responds. The table below sets the label's figures side by side. The FDA label also defines a meaningful change for each score by tying it to other measures. For the desire score, that is a rise of at least 1.2 points. For the distress item, it is a fall of at least 1 point. The average changes in the bremelanotide groups were 0.5 to 0.6 points and −0.7 points. Those are averages across all women. So they do not show how many women crossed those lines. ## What do the PT-141 trial results not show? The PT-141 trial results do not show effects in men, in postmenopausal women, beyond 24 weeks of controlled follow-up, or in groups very different from the women enrolled. More women stopped the 24-week period early on bremelanotide than on placebo. In Study 1 the figures were 40% against 13%. In Study 2 they were 39% against 25%. Stopping because of side effects was 18% on bremelanotide and 2% on placebo. That gap matters, because the women who stayed may differ from those who left. The paper names the companies Palatin and AMAG as funding sources. Because so many more women left the bremelanotide groups, the FDA label includes an exploratory analysis. It counts only women who completed the 24 weeks and met a threshold. An exploratory analysis was not the main test in the trial plan. In that analysis, women who left early are counted as not having improved. The enrolled group also shaped the evidence. Most women were white, and nearly all came from US sites. A result in that group is not a result for everyone. [The side-effects page](/learn/pt-141/pt-141-side-effects) shows how side effects fed into who stayed. ## Are there other studies of PT-141? Yes. A search of ClinicalTrials.gov, the US trial registry, on 16 October 2026 for bremelanotide as an intervention returned ten registered studies. Eight enrol women only. They include two earlier phase 2 trials, a phase 3 bridging trial sponsored by Kwang Dong Pharmaceutical (NCT04943068) and a phase 1 nausea study (NCT03973047). Two enrol adults of any sex: a diabetic kidney disease study (NCT05709444) and an obesity study that pairs bremelanotide with tirzepatide (NCT06565611). The registry posts results for four of the ten: the two RECONNECT trials, NCT01382719 and NCT04179734. The other six show no results. A registry entry records that a study was planned or run. It does not show what the study found. Dhillon and Keam summarise the development programme up to the 2019 approval in a review in *Drugs*. The label also reports a 52-week open-label extension in which 684 women received bremelanotide with no placebo group. Without a placebo group, that design cannot separate the treatment from other influences. ## Comparison Co-primary endpoint results from the FDA label for the two RECONNECT trials, modified intent-to-treat groups. Higher desire scores and lower distress scores are the direction the label calls improvement. These are score changes from baseline, not counts of events. | Measure | Study 1 (NCT02333071) | Study 2 (NCT02338960) | | --- | --- | --- | | Desire score, mean change: bremelanotide vs placebo | 0.5 vs 0.2 (P = 0.0002) | 0.6 vs 0.2 (P < 0.0001) | | Distress item, mean change: bremelanotide vs placebo | −0.7 vs −0.4 (P < 0.0001) | −0.7 vs −0.4 (P = 0.0053) | | Left the 24-week period early: bremelanotide vs placebo | 40% vs 13% | 39% vs 25% | ## Frequently asked questions ### How big was the PT-141 effect in the trials? Across both trials, the difference from placebo was +0.35 points on the desire score and −0.33 points on the distress item, with P < 0.001 for both. These are questionnaire points. The separate count of satisfying sexual events did not differ significantly between groups. ### Were men studied in the PT-141 phase 3 trials? No. Both phase 3 trials enrolled premenopausal women only, and the FDA label states that the approved product is not indicated in men. ### Who paid for the PT-141 trials? The 2019 trial paper by Kingsberg and colleagues names Palatin Technologies, Inc., and AMAG Pharmaceuticals, Inc., as funders of the RECONNECT trials. ### Is there a long-term controlled trial of PT-141? Not in the sources opened for this page. The controlled period lasted 24 weeks, and the 52-week extension had no placebo group. ## Citations - Kingsberg SA, Clayton AH, Portman D, et al.. Obstetrics & Gynecology. 2019;134(5):899-908. DOI: 10.1097/AOG.0000000000003500 - Dhillon S, Keam SJ. Drugs. 2019;79:1599-1606. DOI: 10.1007/s40265-019-01187-w --- Canonical page: https://www.formlaboratories.com/learn/pt-141/pt-141-study-findings Form Laboratories - Perth-based research-use-only peptide supplier, shipping Australia-wide. - Site guide for agents: https://www.formlaboratories.com/llms.txt - Sitemap: https://www.formlaboratories.com/sitemap.xml - Full catalogue: https://www.formlaboratories.com/shop - Contact: hello@formlaboratories.com All materials are supplied for laboratory research use only - not for human or veterinary use, and nothing on this site is medical advice.