# PT-141 Results in the Studies | Melanocortin Peptide Archive

> PT-141 results from the published studies: the numbers from the RECONNECT trials, the early male erectile-activity data, and the long-term safety figures — all cited.

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](/effects).

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