← Human Trials & Peer-Reviewed Studies
1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder
Plain-language guide to NCT02333071: phase 3 randomized trial of PT-141 (Bremelanotide), 723 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02333071
- Phase
- phase 3
- Status
- completed
- Start
- 2014-12
- Completion (planned or actual)
- 2016-07
- Participants
- 723 (actual)
- Design
- randomized, triple-blind, treatment
- Conditions studied
- Hypoactive Sexual Desire Disorder
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 3 trial tested PT-141 (Bremelanotide).
It had two arms (groups): Bremelanotide (BMT/BMT) (experimental) and Placebo (PBO/BMT) (placebo comparator).
The registry classes the interventions as drug and other.
Who Took Part
Enrollment: 723 actual participants took part.
It was open to women only aged from 18 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
The set-up was randomized, parallel-group and triple-blind.
The participants were allocated by chance, so the PT-141 (Bremelanotide) group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Blinding on both sides kept the participants and researchers unaware of who received PT-141 (Bremelanotide).
Those kept unaware of assignments: participant, investigator and outcomes assessor.
It started in 2014-12 with completion listed for 2016-07.
It ran at 91 sites in United States (87) and Canada (4).
Its stated primary purpose is treatment.
What Was Measured
It also tracked 13 secondary outcomes, for example Change From Baseline to End of Study in the Total Score for FSDS-DAO (Item 13) Throughout the Entirety of the Double-blind Phase.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of PT-141 (Bremelanotide) in 723 people.
With 723 participants it is a large trial for this field.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the PT-141 (Bremelanotide) compound page, all human trials.
Our Notes on the Compound
PT-141 (Bremelanotide): A melanocortin (MC4R) agonist that acts on arousal centers in the brain.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.