COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-07-11
Study Completion:2025-11-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06867835

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Locations (Sites)

First Excellence Research Group LLC
Doral, Florida, 33178
United States

Collaborators and Investigators

Sponsor: Cosette Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-11
Study Completion Date2025-11-15

Study Record Updates

Study Start Date2025-07-11
Study Completion Date2025-11-15

Terms related to this study

Additional Relevant MeSH Terms

  • Lactating Mother