Search for Vyleesi reviews and you will find scattered first-person accounts that cannot be checked for who wrote them, what dose they took, or whether they took it at all. There is a better record of what women experienced on it: the phase 3 trials asked them, in surveys and in interviews, and also measured desire, distress and side effects on fixed scales.
This page reads that record the way a review would, starting with what users said, then setting it against the numbers, the dropout rate and the strongest published criticism.
Who it is approved for
Vyleesi is bremelanotide, a melanocortin receptor agonist, injected as needed at least 45 minutes before anticipated sexual activity, and its label restricts it to premenopausal women with acquired, generalized hypoactive sexual desire disorder [1].
The label rules out low desire caused by another medical or psychiatric condition, by relationship problems or by a drug, and states that Vyleesi is not indicated for postmenopausal women, for men, or to enhance sexual performance. The trials behind the approval are set out in bremelanotide’s FDA approval and trials.
What women in the trials said
When the 24-week double-blind phase ended, and before anyone learned which treatment they had received, 242 participants completed an exit survey and 80 of them also gave a telephone interview [2].
Women who had received bremelanotide described increased feelings of sexual desire, physical arousal, and a better overall quality of sexual activity with their partner, while women who had received placebo described benefits of a different kind.
Those placebo benefits were the experience of seeking treatment at all and improved communication with a partner, and they did not include the physical responses the bremelanotide group reported. The published abstract gives these as themes rather than percentages, so no share of women can be attached to them here.
What the scales measured
The label’s two primary measures were a desire score running from 1.2 to 6 and a single distress question scored from 0 to 4, compared at the end of 24 weeks [1].
| Measure | Study 1: Vyleesi | Study 1: placebo | Study 2: Vyleesi | Study 2: placebo |
|---|---|---|---|---|
| Desire score (range 1.2 to 6) | +0.5 | +0.2 | +0.6 | +0.2 |
| Distress over low desire (range 0 to 4) | −0.7 | −0.4 | −0.7 | −0.4 |
| Satisfying sexual events | 0.0 | −0.1 | 0.0 | 0.0 |
Both primary differences were statistically significant, and the published phase 3 report put the integrated gains over placebo at 0.35 points on desire and 0.33 points on distress [3].
The number of satisfying sexual events, a secondary measure, did not differ between the groups in either trial, which is worth holding beside the interview accounts: women reported feeling more desire, but on average they did not record more satisfying encounters.
How many kept using it
A review from someone who stopped after one dose reads differently from one written after a year, and the trials record both kinds of user.
40%
Stopped the 24-week phase early on Vyleesi in Study 1, against 13% on placebo
Vyleesi label
18%
Stopped because of side effects on Vyleesi, against 2% on placebo
Vyleesi label
272
Completed the 52-week extension, of 684 who entered it
Simon 2019
In Study 2 the early-stopping figures were 39% on Vyleesi and 25% on placebo [1]. Nausea alone accounted for 8% of Vyleesi users leaving the trials, and headache, vomiting and flushing for smaller shares.
Of the 856 women eligible after the core phase, 684 chose to continue into the open-label extension and 272 completed it [4]. Those who stayed kept their gains on both measures, which says more about the women who found it worth continuing than about everyone who started.
Use was modest in practice: the median was 10 injections across the 24-week phase, and most women injected two to three times a month [1].
What the critics found
An independent analysis of the RECONNECT trials argued that the desire and distress measures have little validity evidence for women with this diagnosis, and that no validity evidence exists for the responder definitions later published from them [5].
The same authors reported that 8 of 11 efficacy outcomes registered for the trials had not been published, and on those they estimated effect sizes ranging from nil to small, concluding that the benefits were statistically modest.
That critique and the exit interviews are not strictly in conflict: some women described a difference they valued, while the averages and the dropout rate show that the effect was neither large nor universal.
Reading it the way a review would
Put together, the structured record looks like a drug that a subset of women describe as helping with desire and arousal, that a large share stop because of nausea, and whose average effect on the trials’ own scales is small.
How the dose and timing work is covered in PT-141 dosage and how long PT-141 lasts, and the separate question of use in men in PT-141 for men.
To compare prescribers, see the PT-141 prescriber rankings.