RCTNCT00425256Phase 2 · 2006 · Palatin Technologies, Inc Sexual Arousal Disorder
result Completed; results not posted
RCTNCT01382719Phase 2 · 2011 · n=612 · Palatin Technologies, Inc Female Sexual Arousal Disorder
tested The Primary Efficacy Endpoint is Change From Baseline to End of Study in the Number of Satisfying Sexual Events (SSE)
result +0.4 SSEs (The Primary Efficacy Endpoint is Change From Basel…)
RCTNCT02333071Phase 3 · 2014 · n=723 · Palatin Technologies, Inc Hypoactive Sexual Desire Disorder
tested Efficacy of a Fixed Dose of Bremelanotide as Measured by FSFI (Question Q1 and Q2), 28-day Recall.
result +0.3 score on a scale (Efficacy of a Fixed Dose of Bremelanotide as Measu…)
RCTNCT02338960Phase 3 · 2015 · n=714 · Palatin Technologies, Inc Hypoactive Sexual Desire Disorder
tested Efficacy of a Fixed Dose of Bremelanotide as Measured by FSFI (Question Q1 and Q2), 28-day Recall.
result +0.4 score on a scale (Efficacy of a Fixed Dose of Bremelanotide as Measu…)
RCTNCT03973047Phase 1 · 2019 · n=228 · AMAG Pharmaceuticals, Inc. Nausea
tested Incidence of treatment-emergent nausea following BMT with or without concomitant use of Zofran.
result Completed; results not posted
RCTNCT04179734Phase 4 · 2019 · n=40 · Imperial College Healthcare NHS Trust Hypoactive Sexual Desire Disorder
tested Changes in Blood Oxygen Level Dependent (BOLD) Signal Change on Functional MRI
result +2.3 BOLD signal change (Changes in Blood Oxygen Level Dependent (BOLD) Sig…)
RCTNCT04943068Phase 3 · 2021 · n=193 · Kwang Dong Pharmaceutical co., ltd. Hypoactive Sexual Desire Disorder
tested Change from baseline to End of Study in the desire domain from the FSFI
result Completed; results not posted
RCTNCT06565611Phase 2 · 2024 · n=108 · Palatin Technologies, Inc Obesity
tested Percent change in body weight between treatment arms
result In progress (active-not-recruiting)
Treatment studies
tested erectile response assessed by RigiScan
result Statistically significant erectile response vs placebo at doses >7 mg; first erection onset ~30 min; C(max) and AUC dose-dependent; t½ 1.85–2.09 h.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested Indication: female sexual arousal disorder
result Article retracted; results and methods unverifiable. Study was a double-blind, placebo-controlled, fixed-dose RCT evaluating safety and efficacy of bremelanotide.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested International Index of Erectile Function, intercourse satisfaction domain, weekly coitus episodes
result 33.5% positive clinical response with bremelanotide vs 8.5% placebo (p=0.03); greater intercourse satisfaction (p=0.03); more drug-related AEs (p=0.01).
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested satisfying sexual events/month; FSFI total score; FSDS-DAO total score
result 1.25/1.75 mg pooled vs placebo: +0.7 vs +0.2 SSE/month (p=0.0180); +3.6 vs +1.9 FSFI (p=0.0017); -11.1 vs -6.8 FSDS-DAO (p=0.0014)
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested ambulatory blood pressure and heart rate over 0–4h post-dose
result SBP rose 2.4–3.2 mmHg vs placebo at 1.25–1.75 mg (p<0.076–0.006); HR fell 4.6–4.7 bpm at 1.75 mg (p<0.001); peak BP increases <15 min.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested 7 PRO endpoints including FSFI-desire domain, FSDS-DAO total score, items 13 & 14, and number of satisfying sexual events
result All 7 PRO endpoints at 1.75 mg achieved statistically significant responder rates vs placebo (P≤.03) in the overall modified ITT population.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested Change from baseline in FSFI-desire domain score and FSDS-DAO item 13 (distress)
result Desire improved vs placebo (Study 301: +0.30, p<.001; Study 302: +0.42, p<.001; integrated: +0.35, p<.001); distress reduced (integrated: -0.33, p<.001).
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested efficacy on HSDD measures, adverse event-induced discontinuation, participant preference for continuation
result Modest HSDD benefits on post-hoc measures; AE-induced discontinuation OR=11.98 (NNH:6); participants preferred placebo OR=0.30 (NNH:4); 72.72% of protocol outcomes unreported.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested body weight and caloric intake reduction
result Study A: -1.3 kg vs placebo (p<.0001), ~400 kcal/day reduction (p<.01). Study B: -1.7 vs -0.9 kg placebo (p<.001), 398-469 kcal/day reduction (p<.0001).
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested FSFI desire domain score and FSDS-DAO Item 13 distress score, change from baseline at 24 weeks
result Statistically significant improvements in sexual desire and reduced distress vs placebo across all age, weight, BMI subgroups and all baseline bioavailable testosterone quartiles, with few exceptions.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested FSFI, FSFI-D, FSDS-DAO, FSDS-DAO #13, and 8 previously unpublished clinicaltrials.gov-specified outcomes
result Effect sizes ranged from nil to small; statistically modest benefits limited to outcomes with questionable validity; 8/11 pre-specified outcomes previously unpublished.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
OpenNCT05709444Phase 2 · 2022 · n=16 · Palatin Technologies, Inc Kidney Disease
tested To demonstrate the efficacy of 0.5 mg subcutaneous BMT (given twice a day), used in combination with a subject's maximum tolerated dose of RAAS inhibition therapy, reduces urinary protein by 50% from baseline UP/Cr levels.
result Completed; results not posted
Non-randomised; effect size cannot be separated from placebo.
OpenNCT06867835Phase 4 · 2025 · n=10 · Cosette Pharmaceuticals, Inc. Lactating Mother
tested Levels of Bremelanotide (BMT) in Breast Milk Over 24h After Administration of Vyleesi
result Completed; results not posted
Non-randomised; effect size cannot be separated from placebo.
Treatment studies
tested erectile activity
result Rapid dose-dependent increase in erectile activity in normal men and ED patients; animal data show penile erections and hypothalamic c-Fos activation.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested Erectile response measured by RigiScan
result Statistically significant erectile response at doses >1.0 mg in healthy men; both 4 mg and 6 mg PT-141 produced statistically significant responses in Viagra-inadequate ED patients vs placebo.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested Erectile response measured by RigiScan during 6-hour postdose period following visual sexual stimulation
result Co-administration of PT-141 7.5 mg intranasal + sildenafil 25 mg produced significantly greater erectile response than sildenafil alone; safe and well-tolerated.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested Vaginal pulse amplitude during erotic video; subjective sexual desire, genital arousal feelings, and satisfaction with arousal within 24 hours post-treatment
result More women reported moderate/high desire after bremelanotide vs placebo (P=0.0114); trend for positive genital arousal (P=0.0833); more satisfied with arousal post-intercourse (P=0.0256); vaginal vasocongestion NS.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested Female Sexual Function Index-desire domain score and Female Sexual Distress Scale-Desire/Arousal/Orgasm item 13
result FSFI-desire score change 1.25–1.30 (bremelanotide arm) vs 0.70–0.77 (prior placebo arm); FSDS item 13 change -1.4 to -1.7 vs -0.9 over 52 weeks.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested Sexual desire and distress related to lack of desire
result Significant improvement in desire and significant decrease in distress related to lack of desire; nausea 39.9%, facial flushing 20.4%, headache 11%; clinical benefit may be modest.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested Patient-reported sexual desire, physical arousal, quality of sexual activities, and quality of life via exit surveys and telephone interviews
result Bremelanotide recipients reported increased sexual desire, physical arousal, and improved sexual activity quality; placebo recipients reported benefits without physiological responses.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested safety profile: adverse events, blood pressure, focal hyperpigmentation, drug-drug interactions
result Nausea 40.0% vs 1.3%, flushing 20.3% vs 1.3%, headache 11.3% vs 1.9% (bremelanotide vs placebo, N=1247 double-blind phase 3); AEs mostly mild-to-moderate; no deaths.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Preclinical / mechanistic research
tested rat · Selective facilitation of sexual solicitation in the female rat by a melanocortin receptor agonist.
result Preclinical publication captured from PubMed/Europe PMC; effect details require paper-level extraction.