Breastfeeding moms: new study checks drug levels in milk
NCT ID NCT06867835
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed study tested 10 healthy breastfeeding women to see how much of the drug Vyleesi (bremelanotide) passes into breast milk after a single injection. Participants pumped and stored milk before dosing and stopped breastfeeding for the study. Researchers measured drug levels in milk and blood over 24 hours. The goal is to understand if the drug could reach the baby through milk.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Vyleesi (bremelanotide injection)
- What this could lead to
- If results show little drug passes into milk, it may help guide safe use of Vyleesi in breastfeeding mothers.
- What could go wrong
- This is a very small study (10 women) that only looks at a single dose. It cannot determine long-term safety for infants.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
10 people
The number who actually took part.
- Started
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Jul 2025
- Finished
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Nov 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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First Excellence Research Group LLC
Doral, Florida, 33178, United States
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