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PT-141 for Women: Studies and Label Warnings

Studies of PT-141 that enrolled only women, what they measured, and what is still unproven.

Medical review pendingMelanocortin agonistUpdated
Strongest evidence
Human RCT
Studies enrolling only women
7
in our evidence file (PubMed search, 2 Oct 2026)
FDA status
FDA approved for HSDD (Vyleesi)

Studies that enrolled only women

Each row is a study whose participants were described as women only. Results from one sex are not evidence for the other. Studies of animals and cells are not included.

PT-141 studies that enrolled only women
StudyDesignPopulationDoseFirst outcome
Journal of women's health 2022, PMID 35230162Human RCTRECONNECT phase 3 integrated analysis, premenopausal women with HSDD1.75 mgDesire and distress across subgroups: Benefit on desire and distress was seen across age, weight and BMI subgroups.
Journal of women's health 2021, PMID 33538638Human RCTRECONNECT exit survey participants (premenopausal women with HSDD)Not statedPatient-reported experience: Exit surveys and interviews: bremelanotide users described more desire, arousal and better sexual activity quality.
Obstetrics and gynecology 2019, PMID 31599840Human RCTPremenopausal women with hypoactive sexual desire disorder (RECONNECT 301 and 302)1.75 mgSexual desire (FSFI-desire domain): Desire domain score rose more than placebo: 0.30 (study 301), 0.42 (study 302), 0.35 integrated, all P<.001.
The journal of sexual medicine 2019, PMID 31277966Human RCTPremenopausal women with HSDD and mixed HSDD/FSAD (phase 2b dose-ranging, responder analyses)1.75 mgResponder rates: At 1.75 mg, responder rates beat placebo on all 7 endpoints (P ≤ .03).
Journal of hypertension 2017, PMID 27977473Human RCTPremenopausal women with female sexual dysfunction, normotension or controlled hypertension0.75, 1.25 and 1.75 mgNot stated
Women's health 2016, PMID 27181790Human RCTPremenopausal women with female sexual dysfunction (phase 2b)0.75, 1.25 or 1.75 mgSatisfying sexual events: +0.7 versus +0.2 satisfying sexual events per month (p = 0.0180).
The journal of sexual medicine 2006, PMID 16839319Human RCTPremenopausal women with female sexual arousal disorder (single-dose crossover)20 mgSexual desire: More women reported moderate or high desire after bremelanotide than placebo (P = 0.0114).

Peptides studied in women, compared

How strong is it?

Strongest evidence:Human RCT evidence, 4 of 4

A human randomized trial outweighs any number of animal studies. Animal and cell results show a mechanism worth testing, not that it works in people.

The condition the women's studies address

MedlinePlus lists pregnancy, menopause and conditions of the female organs among women's unique health issues, and the trials below enrolled premenopausal women only.[12]

A subgroup analysis of the phase 3 trials defines the target condition as persistent diminished desire for sexual activity accompanied by distress.[1]

Trials that enrolled only women

The two phase 3 RECONNECT trials randomized 1,267 premenopausal women with the disorder.[3]

In a prespecified analysis of 1202 women, improvements in desire and distress held across age, weight and BMI subgroups and all baseline bioavailable testosterone quartiles, with few exceptions.[1]

A phase 2b dose-finding trial of 327 women compared pooled 1.25 and 1.75 mg doses with placebo for satisfying sexual events and found a statistically significant difference.[6]

A responder analysis found that at 1.75 mg the responder rates reached statistical significance against placebo on all 7 endpoints.[4]

Label warnings specific to women

The label tells women who could become pregnant to use effective contraception and to stop if pregnancy is suspected.[13]

On breastfeeding, the label says there is no information on its presence in human milk or its effects on infants or milk production.[13]

Animal studies led the label to say use in pregnant women may be associated with fetal harm.[13]

Other peptides people research for women

Kisspeptin-10HGHhCGSemaglutide
All peptides for women, compared

Common questions

Has PT-141 been studied in women?

7 studies we summarise enrolled only women. Results from one sex are not evidence for the other.

Is PT-141 approved for women?

PT-141 is FDA approved for HSDD (Vyleesi). The label sets who it is approved for; use outside it is off-label.

Is PT-141 safe in pregnancy?

The label advises stopping if pregnancy is suspected, and says animal studies suggest the potential for fetal harm.[13]

Does PT-141 work for postmenopausal women?

The approved product is not indicated for postmenopausal women, and the trials cited here enrolled premenopausal women.[13]

More on PT-141

DosageDoses used in published studies, with the source for each.CalculatorVial, water and dose to syringe units.Side effectsWhat labels and studies report, and what is unknown.BenefitsClaimed benefits next to what published studies measured.How it worksTarget, mechanism and how long it acts, from the label or studies.Nasal sprayStudies that gave PT-141 as nasal spray, and what is approved.

Sources

  1. 1Prespecified and Integrated Subgroup Analyses from the RECONNECT Phase 3 Studies of Bremelanotide.Journal of women's health (2002) · 2022PMID 35230162Accessed 2 Oct 2026
  2. 2The Patient Experience of Premenopausal Women Treated with Bremelanotide for Hypoactive Sexual Desire Disorder: RECONNECT Exit Study Results.Journal of women's health (2002) · 2021PMID 33538638Accessed 2 Oct 2026
  3. 3Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials.Obstetrics and gynecology · 2019PMID 31599840Accessed 2 Oct 2026
  4. 4Responder Analyses from a Phase 2b Dose-Ranging Study of Bremelanotide.The journal of sexual medicine · 2019PMID 31277966Accessed 2 Oct 2026
  5. 5Usefulness of ambulatory blood pressure monitoring to assess the melanocortin receptor agonist bremelanotide.Journal of hypertension · 2017PMID 27977473Accessed 2 Oct 2026
  6. 6Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial.Women's health (London, England) · 2016PMID 27181790Accessed 2 Oct 2026
  7. 7An effect on the subjective sexual response in premenopausal women with sexual arousal disorder by bremelanotide (PT-141), a melanocortin receptor agonist.The journal of sexual medicine · 2006PMID 16839319Accessed 2 Oct 2026
  8. 8PubMed search: bremelanotide[tiab] OR "PT-141"[tiab] OR PT141[tiab] (114 results)PubMed · 2026pubmed.ncbi.nlm.nih.govAccessed 2 Oct 2026
  9. 9PubMed search: (bremelanotide[tiab] OR "PT-141"[tiab]) AND randomized controlled trial[pt] (14 results)PubMed · 2026pubmed.ncbi.nlm.nih.govAccessed 2 Oct 2026
  10. 10PubMed search: (bremelanotide[tiab] OR "PT-141"[tiab]) AND (half-life[tiab] OR pharmacokinetic*[tiab]) (7 results)PubMed · 2026pubmed.ncbi.nlm.nih.govAccessed 2 Oct 2026
  11. 11PubMed search: (bremelanotide[tiab] OR "PT-141"[tiab] OR PT141[tiab]) AND (erectile[tiab] OR men[tiab]) (20 results)PubMed · 2026pubmed.ncbi.nlm.nih.govAccessed 2 Oct 2026
  12. 12Official web pageOfficial web page · web page
  13. 13VYLEESI prescribing information (FDA label)FDA label, DailyMed · current labeldailymed.nlm.nih.govAccessed 2 Oct 2026

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