Current partner codePEPTIDESDE
NCT06867835·Phase 4·INTERVENTIONAL

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

Status

Completed

Phase

Phase 4

Enrollment

10

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Vyleesi (Bremelanotide Injection)

Single dose of BMT 1.75 mg SC on Day 1

Timeline

From registration to results.

  1. First posted

    Mar 10, 2025

  2. Study start

    Jul 11, 2025

  3. Primary completion

    Nov 15, 2025

  4. Study completion

    Nov 15, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Jan 13, 2026

Outcomes

What the study measures.

Primary outcomes

Levels of Bremelanotide (BMT) in Breast Milk Over 24h After Administration of Vyleesi

Time frame · 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

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

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
55 Years
Sex
FEMALE
Healthy volunteers
No

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

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

First Excellence Research Group LLC

Doral, Florida, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Bremelanotide / PT-141.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.