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Trial · Interventional

CompletedPhase 4Registry data

Single 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
20252026
  1. Ph 4

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

    NCT06867835

    11 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.

  1. 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).

  2. Area under the curve from time 0 to end of dosing interval (AUCtau) for BMT in Breast Milk

    Time frame · 24 hours

  3. Maximum observed concentration (Cmax) of BMT in breast milk

    Time frame · 24 hours

  4. Time to reach Cmax of BMT in breast milk (Tmax)

    Time frame · 24 hours

  5. Terminal half-life of BMT in breast milk (t1/2)

    Time frame · 24 hours

Secondary outcomes(5)
  1. Levels of Bremelanotide (BMT) in Plasma Over 24h After Administration of Vyleesi

    Time frame · 24 hours

  2. Area under the curve from time 0 to end of dosing interval (AUCtau) for BMT in Plasma

    Time frame · 24 hours

  3. Maximum observed concentration (Cmax) of BMT in Plasma

    Time frame · 24 hours

  4. Time to reach Cmax of BMT in Plasma (Tmax)

    Time frame · 24 hours

  5. 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
Inclusion Criteria (Main Criteria): * Female subjects ≥18 to 55 years of age (inclusive) and premenopausal * Lactating, between 10 days and 6 months postpartum (inclusive). * Exclusively breastfeeds their infant prior to participation in the study * Is willing to pump and store breastmilk for feeding her infant for a minimum of 48 hours in advance of study initiation and discontinue breastfeeding their infant for the duration of their study participation (beginning from time of dosing with BMT) and a minimum of 24 hours following the Safety Follow-Up visit (i.e., a minimum of 48 hours following dosing with BMT). * Ensure at the time of screening that the breastfed infant can feed from a bottle during maternal participation in the study * The subject is not pregnant, and does not intend to become pregnant before, during, or within 1 complete menstrual cycle or 2 months after administration of study drug * Subjects of childbearing potential who are sexually active with a nonsterilized male partner must have stable, continuous use of an acceptable method of contraception throughout the duration of the study, and for at least 60 days after the dose of study drug Exclusion Criteria (Main Criteria): * Breastfeeding is not well established in the mother-infant pair (e.g., poor latching of the infant or low milk supply). * Any condition that interferes with the successful collection of milk from one or both breasts including but not limited to lactation mastitis (typically presents as a tender, hot, swollen area of the breast that may or may not involve an infection), milk blister that may present as a blocked nipple pore, breast abscess, etc. * Has used any investigational compound and/or an experimental medical device within 28 days before Screening. * Has taken BMT within 24 hours of participation in the study

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