Vyleesi for Lactating Mothers

Overseen By CRA

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: Cosette Pharmaceuticals, Inc.

Disqualifiers: Poor breastfeeding, Mastitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Vyleesi, an injection, is present in the breast milk of women who have recently given birth. Researchers seek to measure the medication's concentration in the milk after a single dose. The study seeks healthy breastfeeding mothers between 10 days and 6 months post-birth who are willing to pump and store their milk temporarily. Participants must be prepared to stop direct breastfeeding during the study and ensure their baby can feed from a bottle. As a Phase 4 trial, Vyleesi is already FDA-approved and proven effective, and this research helps to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for Vyleesi?

Research has shown that Vyleesi, also known as bremelanotide, is already approved by the FDA for certain conditions, indicating its safety for most people. However, limited information exists about its use during breastfeeding. Some sources suggest that breastfeeding mothers, particularly those with newborns or premature babies, should exercise caution.

Specific studies on the effects of Vyleesi on breastfeeding women are lacking, so the risks to infants remain unclear. It is crucial to weigh the benefits of the treatment against any potential risks. Consulting a healthcare provider before joining a clinical trial is essential, especially for those who are breastfeeding. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Vyleesi is unique because it offers a new avenue for enhancing sexual desire in lactating mothers, a group often underserved by current treatments. Unlike standard options that might not specifically address this population, Vyleesi is administered via a simple subcutaneous injection, making it easy to use. It works by activating melanocortin receptors, which is a different mechanism compared to traditional therapies that target hormones or neurotransmitters. Researchers are excited about Vyleesi because it could potentially provide quick and effective relief with just a single dose, making it a promising option for improving sexual health postpartum.

What is the effectiveness track record for Vyleesi?

Research shows that Vyleesi (Bremelanotide) is an approved treatment for low sexual desire in premenopausal women. Studies have found that it effectively boosts sexual desire and reduces the distress caused by low desire. In trials, women using Vyleesi reported noticeable improvements in their sexual desire compared to those who did not use it. Vyleesi activates certain parts of the brain related to sexual desire. This trial focuses on how Vyleesi passes into breast milk, while its effectiveness for its approved use has already been proven. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for healthy lactating women who are 10 days to 6 months postpartum, not pregnant, and do not plan to become pregnant soon. Participants must have been exclusively breastfeeding and agree to pump milk in advance and stop breastfeeding during the study. They should also be able to bottle-feed their infant and use reliable contraception if sexually active.

Inclusion Criteria

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

Lactating, between 10 days and 6 months postpartum (inclusive)

Exclusively breastfeeds their infant prior to participation in the study

Exclusion Criteria

Has used any investigational compound and/or an experimental medical device within 28 days before Screening

Breastfeeding is not well established in the mother-infant pair (e.g., poor latching of the infant or low milk supply)

Has taken BMT within 24 hours of participation in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3 weeks

Treatment

Participants receive a single dose of Vyleesi (Bremelanotide Injection) 1.75 mg SC

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 7 days

What Are the Treatments Tested in This Trial?

Interventions

• Vyleesi

Trial Overview

The trial tests how a single dose of Vyleesi (Bremelanotide Injection) affects breast milk. Specifically, it looks at whether Bremelanotide is secreted into the milk and measures its concentration over time in 10 participants.

How Is the Trial Designed?

Group I: Vyleesi Experimental Treatment 1 Intervention

One dose of BMT 1.75 mg SC on Day 1

Who Is Running the Clinical Trial?

Cosette Pharmaceuticals, Inc.

Lead Sponsor

Trials

1

Recruited

10+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06867835?tab=history&a=1

Record History | ver. 1: 2025-03-05 | NCT06867835

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 ...

2.

guidelinecentral.com

guidelinecentral.com/clinical-trial/?id=NCT06867835

Single Dose of Vyleesi in Lactating Female Subjects to ...

Outcome Measures​​ The levels/concentrations of bremelanotide (BMT) will be measured in breast milk samples collected at different timepoints up to 24h from ...

3.

withpower.com

withpower.com/trial/phase-4-lactating-mother-3-2025-289ec

Vyleesi for Lactating Mothers

This trial is for healthy lactating women who are 10 days to 6 months postpartum, not pregnant, and do not plan to become pregnant soon.

4.

ctv.veeva.com

ctv.veeva.com/study/single-dose-of-vyleesi-in-lactating-female-subjects-to-measure-the-concentration-of-bremelanotide-in

Single Dose of Vyleesi in Lactating Female Subjects to ...

The primary objectives of this clinical trial performed with Vyleesi (Bremelanotide Injection) are: to evaluate if Bremelanotide (BMT) is ...

5.

drugs.com

drugs.com/pregnancy/bremelanotide.html

Bremelanotide (Vyleesi) Use During Pregnancy

-There are no data on the effects of this drug on the breastfed infant or its effects on milk production. -The developmental and health benefits ...

6.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2019/210557s000lbl.pdf

Vyleesi (bremelanotide) - accessdata.fda.gov

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to ...

7.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK544629/

Bremelanotide - Drugs and Lactation Database (LactMed®)

Summary of Use during Lactation. No information is available on the clinical use of bremelanotide during breastfeeding.

8.

drugs.com

drugs.com/breastfeeding/bremelanotide.html

Bremelanotide (Vyleesi) use while Breastfeeding

Bremelanotide should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.

9.

mayoclinic.org

mayoclinic.org/drugs-supplements/bremelanotide-subcutaneous-route/description/drg-20466805

Bremelanotide (subcutaneous route) - Side effects & dosage

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits ...