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

Phase 4

Not yet recruiting

• Conditions: Lactating Mother
• Interventions: Drug: Vyleesi (Bremelanotide Injection)

• Registration Number: NCT06867835
• Lead Sponsor: Cosette Pharmaceuticals, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-19
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-05
• Last Update Submitted: 2025-03-05
• Study First Posted: 2025-03-10
• Last Update Posted: 2025-03-10
• Study Start: 2025-04
• Primary Completion: 2025-07
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vyleesi	Vyleesi (Bremelanotide Injection)	One dose of BMT 1.75 mg SC on Day 1

Primary Outcome Measures

Name	Time	Method
Levels of Bremelanotide (BMT) in Breast Milk Over 24h After Administration of Vyleesi	24 hours	The levels/concentrations of bremelanotide (BMT) will be measured in breast milk samples collected at different timepoints up to 24h from lactating women who receive a single dose of Vyleesi (BMT 1.75 mg SC).
Area under the curve from time 0 to end of dosing interval (AUCtau) for BMT in Breast Milk	24 hours
Time to reach Cmax of BMT in breast milk (Tmax)	24 hours
Maximum observed concentration (Cmax) of BMT in breast milk	24 hours
Terminal half-life of BMT in breast milk (t1/2)	24 hours

Secondary Outcome Measures

Name	Time	Method
Levels of Bremelanotide (BMT) in Plasma Over 24h After Administration of Vyleesi	24 hours
Area under the curve from time 0 to end of dosing interval (AUCtau) for BMT in Plasma	24 hours
Maximum observed concentration (Cmax) of BMT in Plasma	24 hours
Time to reach Cmax of BMT in Plasma (Tmax)	24 hours
Milk:plasma ratio (M/P) of BMT Levels	24 hours