Trial · Interventional
CompletedPhase 4Registry dataSingle Dose of Vyleesi in Lactating Female Subjects to Measure the Concentration of Bremelanotide in Breast Milk
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 10 participants (actual)
- Sponsor
- Cosette Pharmaceuticals, Inc. · Industry
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
United States
- Start
- 11 Jul 2025
- Primary completion
- 15 Nov 2025
- Completion
- 15 Nov 2025
- First posted
- 10 Mar 2025
- Last update posted
- 13 Jan 2026
- Conditions
- Lactating Mother
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 4
Single Dose of Vyleesi in Lactating Female Subjects to Measure the Concentration of Bremelanotide in Breast Milk
NCT0686783511 Jul 2025 to 15 Nov 2025
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Vyleesi (Bremelanotide Injection)Drug
Arms1
Experimental
Vyleesi
One dose of BMT 1.75 mg SC on Day 1
Primary outcomes5
Outcomes the sponsor listed as primary.
Levels of Bremelanotide (BMT) in Breast Milk Over 24h After Administration of Vyleesi
Time frame · 24 hours
Registry description
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
Time frame · 24 hours
Maximum observed concentration (Cmax) of BMT in breast milk
Time frame · 24 hours
Time to reach Cmax of BMT in breast milk (Tmax)
Time frame · 24 hours
Terminal half-life of BMT in breast milk (t1/2)
Time frame · 24 hours
Secondary outcomes(5)
Levels of Bremelanotide (BMT) in Plasma Over 24h After Administration of Vyleesi
Time frame · 24 hours
Area under the curve from time 0 to end of dosing interval (AUCtau) for BMT in Plasma
Time frame · 24 hours
Maximum observed concentration (Cmax) of BMT in Plasma
Time frame · 24 hours
Time to reach Cmax of BMT in Plasma (Tmax)
Time frame · 24 hours
Milk:plasma ratio (M/P) of BMT Levels
Time frame · 24 hours
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 18 Years up to 55 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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