drugset
drugset / Trial / NCT03973047

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

NCT03973047 ↗

Phase 1 Completed 228 enrolled AMAG Pharmaceuticals, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2019-06-17
Primary completion
2019-07-19
Completion
2019-07-20

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bremelanotide Peptide 1.75 mg Subcutaneous
Comparator Ondansetron Other / unclassified 8 mg Oral

Indications

No indication recorded.