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Bremelanotide dosage in clinical trials

What dose levels researchers actually tested, quoted from the trial registry and the published reports — so the numbers circulating online can be checked against their source.

Doses in published trials

Table 1. Dose arms of the principal published Bremelanotide trials, as reported in the cited paper.
TrialPopulationDose armsScheduleRef.
RECONNECT 301 and 302 (phase 3)Premenopausal women with HSDD; 1,267 randomized1.75 mgSC as needed, 24 weeks1
RECONNECT open-label extension684 women1.75 mgSC as needed, 52 weeks2
Phase 2b dose-rangingPremenopausal women with HSDD and/or FSAD1.75 mg (dose carried into phase 3)SC3
Phase 1 obesity crossover (Study B)Premenopausal women, BMI >302.5 mg / 2.0 mgSC once or twice daily, 4-day periods4
Figure 1. Dose levels named in ClinicalTrials.gov arm descriptions that mention Bremelanotide, counted once per study (5 interventional studies). Includes titration steps and single-dose pharmacology studies; a level appearing often is not evidence that it is effective or safe.

Arms as registered

Verbatim arm text from ClinicalTrials.gov. Only arms naming Bremelanotide and a dose are shown.

  1. NCT02338960 · Phase 3 · Completed · n=714

    2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder

    • Bremelanotide (BMT/BMT) — (Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks (OLE Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks
    • Placebo (PBO/BMT) — (Main Study) PBO administered SC on an as-desired basis for 24 weeks (OLE Study) subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks

  2. NCT02333071 · Phase 3 · Completed · n=723

    1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder

    • Bremelanotide (BMT/BMT) — (Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks (OLE Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks
    • Placebo (PBO/BMT) — (Main Study) PBO administered SC on an as-desired basis for 24 weeks (OLE Study) subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks

  3. NCT06867835 · Phase 4 · Completed · n=10

    Single Dose of Vyleesi in Lactating Female Subjects to Measure the Concentration of Bremelanotide in Breast Milk

    • Vyleesi — One dose of BMT 1.75 mg SC on Day 1

  4. NCT04179734 · Phase 4 · Completed · n=40

    Role of the Melanocortin-4 Receptor in Hypoactive Sexual Desire Disorder

    • Intervention — Bremelanotide 1.75 mg - prefilled subcutaneous autoinjector containing 1.75 mg Bremelanotide in a 0.3 mL solution volume.
    • Placebo — 1.75 mg equivalent - prefilled subcutaneous autoinjector containing Bremelanotide formulation without the active ingredient in a 0.3 mL solution volume.

  5. NCT01382719 · Phase 2 · Completed · n=612

    Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder

    • bremelanotide arm 1 — Low dose: Investigational product: Bremelanotide aqueous solution for subcutaneous (SC) injection, provided as pre-filled syringes containing 0.75 mg in 0.3 mL volume. Subjects will self-administer bremelanotide by SC injection into the anterior thigh or abdomen.
    • bremelanotide arm 2 — Middle dose: Investigational product: Bremelanotide aqueous solution for subcutaneous (SC) injection, provided as pre-filled syringes containing 1.25 mg in 0.3 mL volume. Subjects will self-administer bremelanotide by SC injection into the anterior thigh or abdomen.
    • bremelanotide arm 3 — High dose: Investigational product: Bremelanotide aqueous solution for subcutaneous (SC) injection, provided as pre-filled syringes containing 1.75 mg in 0.3 mL volume. Subjects will self-administer bremelanotide by SC injection into the anterior thigh or abdomen.

References

Every source below was retrieved from its official API or page and cached on the data-edition date. Numbers match the margin notes.

  1. 1 PubMed Kingsberg SA, Clayton AH, Portman D, et al. Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials. Obstet Gynecol 2019. PMID 31599840; doi:10.1097/AOG.0000000000003500.
  2. 2 PubMed Simon JA, Kingsberg SA, Portman D, et al. Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder. Obstet Gynecol 2019. PMID 31599847; doi:10.1097/AOG.0000000000003514.
  3. 3 PubMed Althof S, Derogatis LR, Greenberg S, et al. Responder Analyses from a Phase 2b Dose-Ranging Study of Bremelanotide. J Sex Med 2019. PMID 31277966; doi:10.1016/j.jsxm.2019.05.012.
  4. 4 PubMed Spana C, Jordan R, Fischkoff S. Effect of bremelanotide on body weight of obese women: Data from two phase 1 randomized controlled trials. Diabetes Obes Metab 2022. PMID 35170192; doi:10.1111/dom.14672.

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