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?

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.

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+