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

The primary objectives of this clinical trial performed with Vyleesi (Bremelanotide Injection) are: * to evaluate if Bremelanotide (BMT) is secreted in breast milk of lactating women treated with a single dose of BMT 1.75 mg SC. * to measure the concentration and characterize the pharmacokinetics of BMT secreted in breast milk of lactating women treated with a single dose of BMT 1.75 mg SC. This open-label, pharmacokinetic (PK) study will be performed in 10 healthy lactating female subjects between 10 days and 6 months post-partum (inclusive). The maximum duration of subject participation in the study will be approximately 29 days, consisting of 3-week Screening period, a 1 day treatment period, and up to a 7 day follow-up period.

NCT Number	NCT06867835
Lead Sponsor	Cosette Pharmaceuticals, Inc.
Conditions	Lactating Mother
Enrollment	10 participants
Start Date	2025-07-11
Primary Completion	2025-11-15 (estimated)
Study Completion	2025-11-15 (estimated)
Updated on ClinicalTrials.gov	2026-01-13