A Phase 3, Bridging, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (With or Without Decreased Arousal)

What Was Tested

In this phase 3 trial, researchers set out to test PT-141 (Bremelanotide).

It had two arms (groups): Bremelanotide (experimental) and Placebo (placebo comparator).

Bremelanotide (BMT) subcutaneously (SC) via auto-injector for 8-weeks double-Blind period.

Placebo subcutaneously (SC) via auto-injector for 4-weeks single-Blind period and for 8-weeks double-Blind period.

The registry classes the interventions as drug.

Who Took Part

The registry lists 193 actual participants took part.

It was open to women only aged from 19 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Has met diagnostic criteria for HSDD for at least 6 months. Is willing and able to understand and comply with all study requirements. Has a normal pelvic examination at screening.

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: not currently under treatment for the sexual dysfunction and willing to forego other treatments through the course of the clinical trial.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Because people in this PT-141 (Bremelanotide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on PT-141 (Bremelanotide), so expectations could not easily colour the readings.

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

It started in 2021-05-10 with completion listed for 2023-05-16.

It ran at 1 site in South Korea.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change from baseline to End of Study in the desire domain from the FSFI (time frame: Baseline up to End of Study(8weeks)).

It also tracked 14 secondary outcomes, for example Change from baseline to End of Study in FSDS-DAO (Item 13), Change from Baseline to End of Study in Mean Desire Score (Q3) From FSEP-R, Change from Baseline to End of Study in Mean Satisfaction With Desire Score (Q4) From FSEP-R, Change from Baseline to End of Study in the FSDS-DAO Total Score, Change from Baseline to End of study in the total FSFI score based on the 19 questions and Change in mean Level of Sexual Arousal from FSEP-R Q6.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of PT-141 (Bremelanotide) in 193 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.