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PT-141

Bremelanotide, Vyleesi

Quick Stats
Studies 74
Trials 10
Completed PHASE1 INTERVENTIONAL NCT03973047

Study to Evaluate Rate of Nausea in Healthy Premenopausal Female Subjects Treated With Single Dose of Bremelanotide Alone or With Zofran

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This is a Phase 1, randomized study to evaluate the rate of nausea in healthy premenopausal study participants following a single dose of BMT with or without a single 8 mg po dose of Zofran given 30 minutes before BMT dosing.

Detailed Description

This is a Phase 1, randomized study to evaluate the rate of nausea in healthy premenopausal study participants following a single dose of BMT with or without a single 8 mg po dose of Zofran given 30 minutes before BMT dosing. The study consists of a 21-day screening period for subject eligibility followed by a 1-day double-blind period in which all subjects receive a single open-label dose of 1.75 mg SC BMT after receiving a single blinded dose of Zofran (ondansetron) 8 mg or placebo. Approximately 228 subjects will be enrolled at up to two study sites in the United States. Safety and tolerability of BMT administration will be summarized and assessed.

Interventions

Name: Bremelanotide
Type: DRUG
Description: Sterile aqueous solution for injection, provided as an autoinjector pen
Name: Zofran
Type: DRUG
Description: 8 mg tablet (over-encapsulation in a capsule)
Name: Placebo
Type: DRUG
Description: capsule

Primary Outcomes

Measure: Incidence of treatment-emergent nausea following BMT with or without concomitant use of Zofran.
TimeFrame: 2 Days
Description: Incidence of treatment-emergent nausea following a single dose of BMT 1.75 mg SC with or without concomitant use of Zofran.

Trial Information

NCT ID

NCT03973047

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE1

Sponsor

AMAG Pharmaceuticals, Inc.

Last Updated

December 15, 2025