Research archive · Outcomes
PT-141 Results in the Studies
The actual numbers — desire scores, adverse-event rates, and the early male erectile data — pulled from the published record.
The short version
This page gathers the PT-141 results as the studies reported them — plain numbers, each cited. The headline outcomes come from the two large female trials. A 1.75 mg as-needed injection improved a validated desire score (an integrated FSFI-desire change of +0.35, P<.001) and lowered desire-related distress (an integrated FSDS distress item of -0.33, P<.001) versus placebo over 24 weeks [3].
Those gains are statistically real but modest, and independent re-analyses have argued they are small in everyday terms [3]. In men, the early studies showed real erectile activity [1][8] but the program never reached approval [7]. Below, the female trial numbers, the long-term safety figures, and the early male data — each with the source ruled beneath.
The female trial numbers (PT-141 reviews of the evidence)
Most serious PT-141 reviews of the evidence center on RECONNECT — two identical Phase 3 trials enrolling 1,267 premenopausal women with acquired, generalized low sexual desire and distress [3]. Both trials met their two main goals: the 1.75 mg as-needed injection beat placebo on the desire score (+0.35, P<.001) and on the desire-distress measure (-0.33, P<.001) across 24 weeks [3].
The most common side effects in the trials were nausea, flushing, and headache [3]. A 52-week open-label extension of 684 women confirmed the desire gains held with no new safety signals; over that longer window, drug-related nausea reached about 40.4%, flushing about 20.6%, and headache about 12.0% [4]. The fair read: a real, repeatable, but moderate benefit, with nausea as the main tolerability cost.
The early male results
In men, the published results predate the female approval. Animal and early human work showed that PT-141 produced rapid, dose-dependent erectile activity in men with erectile dysfunction [1]. A nasal-spray study in healthy men and men with mild-to-moderate erectile dysfunction reported dose-dependent blood levels, a peak at about half an hour, and a statistically significant erectile response above a 7 mg dose, with first erections at roughly 30 minutes [8].
A combination study paired a low intranasal dose with a PDE-5 inhibitor and reported an enhanced erectile response, testing the central-plus-peripheral idea [10]. One older trial reported that intranasal 10 mg helped 33.5% of men who had not responded to a standard pill, versus 8.5% on placebo — but a 2023 Expression of Concern was issued for that paper, so its result is disputed and should not be taken at face value [12]. The injection route was also studied in men before development shifted away from male erectile dysfunction [9].
How to read these results honestly
Two honest framings keep these results in proportion. First, statistical significance is not the same as a large effect. The female desire and distress changes were real and reproducible across two trials, yet small in absolute terms, and critics question how much they change daily life [3]. The benefit is genuine and modest at the same time.
Second, 'studied' is not 'approved.' The male erectile data is real [1][8], but PT-141 was never approved for men and the disputed salvage study should carry an asterisk [7][12]. The approval is narrow and specific: premenopausal women with HSDD [7]. This site reports the numbers and the caveats together, never one without the other. The full safety picture is on PT-141 effects.