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

What Was Tested

This registered phase 1 trial tested PT-141 (Bremelanotide).

It had two arms (groups): Group 1: BMT plus placebo (placebo comparator) and Group 2: BMT plus Zofran (active comparator).

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

The registry lists 228 actual participants took part.

It was open to women only aged from 18 years up to 55 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Willing and able to provide written informed consent prior to participating in the study. Able to communicate clearly with the Principle Investigator (PI) and staff; able to read English, complete questionnaires, and understand study procedures.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: postmenopausal female, designated by having amenorrhea for ≥12 months; has any of the following:.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the PT-141 (Bremelanotide) group and the comparison group should start out alike.

The PT-141 (Bremelanotide) group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received PT-141 (Bremelanotide).

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2019-06-17 with completion listed for 2019-07-19.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Incidence of treatment-emergent nausea following BMT with or without concomitant use of Zofran (time frame: 2 Days).

It also tracked 3 secondary outcomes, for example Severity of nausea using a Visual Analog Scale, Time to onset of nausea and Duration of nausea.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of PT-141 (Bremelanotide) in 228 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the PT-141 (Bremelanotide) compound page, all human trials.