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A Phase 4, Open-Label Study of a Single Dose of Vyleesi® (Bremelanotide Injection) in Healthy, Premenopausal Lactating Female Subjects to Measure the Concentration of Bremelanotide in Breast Milk

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Trial Profile

A Phase 4, Open-Label Study of a Single Dose of Vyleesi® (Bremelanotide Injection) in Healthy, Premenopausal Lactating Female Subjects to Measure the Concentration of Bremelanotide in Breast Milk

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 19 Jan 2026

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At a glance

  • Drugs Bremelanotide (Primary)
  • Indications Diabetic nephropathies; Female sexual dysfunction; Obesity
  • Focus Pharmacokinetics
  • Sponsors Cosette Pharmaceuticals

Most Recent Events

  • 13 Jan 2026 Status changed from recruiting to completed.
  • 14 Jul 2025 Planned End Date changed from 1 Oct 2025 to 1 Dec 2025.
  • 14 Jul 2025 Planned primary completion date changed from 1 Jul 2025 to 1 Sep 2025.

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