Lactating MotherPhase 4NCT06867835
Single Dose of Vyleesi in Lactating Female Subjects to Measure the Concentration of Bremelanotide in Breast Milk
A Phase 4 study testing Vyleesi (Bremelanotide Injection) in people with Lactating Mother, run by Cosette Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Lactating Mother
- What is being tested?
- Vyleesi (Bremelanotide Injection)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2025to 15 Nov 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
First Excellence Research Group LLC
Doral, Florida, 33178
About this study
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
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.
- Conditions
- Lactating Mother
- Being tested
- Vyleesi (Bremelanotide Injection)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vyleesi (Bremelanotide Injection)Drug
Single dose of BMT 1.75 mg SC on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Vyleesi | Experimental | One dose of BMT 1.75 mg SC on Day 1 Receives: Drug: Vyleesi (Bremelanotide Injection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of Bremelanotide (BMT) in Breast Milk Over 24h After Administration of Vyleesi
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).
Measured: 24 hours
Area under the curve from time 0 to end of dosing interval (AUCtau) for BMT in Breast Milk
Measured: 24 hours
Maximum observed concentration (Cmax) of BMT in breast milk
Measured: 24 hours
Time to reach Cmax of BMT in breast milk (Tmax)
Measured: 24 hours
Terminal half-life of BMT in breast milk (t1/2)
Measured: 24 hours
Secondary outcomes (5)
Levels of Bremelanotide (BMT) in Plasma Over 24h After Administration of Vyleesi
Measured: 24 hours
Area under the curve from time 0 to end of dosing interval (AUCtau) for BMT in Plasma
Measured: 24 hours
Maximum observed concentration (Cmax) of BMT in Plasma
Measured: 24 hours
Time to reach Cmax of BMT in Plasma (Tmax)
Measured: 24 hours
Milk:plasma ratio (M/P) of BMT Levels
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start11 Jul 2025
- Primary completion15 Nov 2025
- Study completion15 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lactating MotherStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cosette Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867835
- Sponsor's protocol ID
- PMR 3635-3
- Status last verified
- Jan 2026
- First submitted
- 19 Feb 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06867835
- Acronym / sponsor ID
- PMR 3635-3
- Conditions
- Lactating Mother
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cosette Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Jul 2025 (actual)
- Primary completion
- 15 Nov 2025 (actual)
- Study completion
- 15 Nov 2025 (actual)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vyleesi | Experimental | Drug: Vyleesi (Bremelanotide Injection)One dose of BMT 1.75 mg SC on Day 1 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vyleesi (Bremelanotide Injection)Single dose of BMT 1.75 mg SC on Day 1 | Drug | Vyleesi |
Primary outcome
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
5 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
Related trials for Lactating Mother
RecruitingPhase 2/3
Milk Volume Outcomes Following Oral Nicotinamide Riboside Supplementation in Mothers of Extremely Preterm Infants
Preterm Birth, Inadequate Milk Production
Active, not recruitingPhase 4
Concentration of Ofatumumab in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis
Multiple Sclerosis
RecruitingObservational study
Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
Lactating Women on Select DOI, Breastfed Infants of Mothers on Select DOI
Recruiting
Pumping to Up Maternal Milk Production for Preterms
Breastfeeding, Breastmilk Expression
RecruitingObservational study
Protective Effect of Lactation Against Gestational Diabetes Mellitus in Subsequent Pregnancies: A Prospective Observational Cohort Study
Gestational Diabetes Mellitus (GDM), Lactating Mother
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vyleesi (Bremelanotide Injection) in people with Lactating Mother, run by Cosette Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of Bremelanotide (BMT) in Breast Milk Over 24h After Administration of Vyleesi (time frame: 24 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.