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Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder
Plain-language guide to NCT01382719: phase 2 randomized trial of PT-141 (Bremelanotide), 612 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01382719
- Phase
- phase 2
- Status
- completed
- Start
- 2011-06
- Completion (planned or actual)
- 2012-09
- Participants
- 612 (actual)
- Design
- randomized, triple-blind, treatment
- Conditions studied
- Female Sexual Arousal Disorder; Hypoactive Sexual Desire Disorder
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2) is built around PT-141 (Bremelanotide).
It had four arms (groups): Placebo (placebo comparator), bremelanotide arm 1 (experimental), bremelanotide arm 2 (experimental) and bremelanotide arm 3 (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 612 actual participants took part.
It was open to women only aged from 21 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
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.
The PT-141 (Bremelanotide) group and the comparison group ran side by side rather than switching.
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, investigator and outcomes assessor.
It started in 2011-06 with completion listed for 2012-09.
It ran at 68 sites in United States (65) and Canada (3).
Its stated primary purpose is treatment.
What Was Measured
It also tracked 6 secondary outcomes, for example Change From Baseline to End-of-Study in Arousal Domain Score From Female Sexual Function Index, Satisfaction With Arousal as Measured by GAQ Question 1, Desire Domain From Female Sexual Function Index, Satisfaction With Desire as Measured by GAQ Question 2, Quality of Relationship With Partner as Measured by GAQ Question 4 and FSDS-DAO Total Score.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of PT-141 (Bremelanotide) in 612 people.
With 612 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.