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NCT01382719 · ClinicalTrials.gov registry record · Phase 2
Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder
A Phase 2 study, sponsored by Palatin Technologies.
- Completed
- Registry status
- Phase 2
- Development phase
- 612
- Enrollment target
NCT01382719: Completed Phase 2 study, sponsored by Palatin Technologies.
NCT01382719 is a Phase 2 study that has completed, run by Palatin Technologies. The registered enrollment target is 612 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (360% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01382719, a Phase 2 study, has completed, sponsored by Palatin Technologies.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 612 participants
- Enrollment target
Study Summary
This trial is designed to evaluate the efficacy and safety of 3 fixed dose levels of bremelanotide, administered subcutaneously on an as-needed basis under conditions of home use, for the treatment of female sexual arousal disorder (FSAD), hypoactive sexual desire disorder (HSDD), or mixed FSAD/HSDD in premenopausal women.
Primary Outcome
The primary efficacy endpoint is change from baseline to end of study in the number of satisfying sexual events (SSEs), computed as the number of events during the last 4 weeks of treatment with FSEP-R Q10 = "Yes" minus the number of baseline events with FSEP-R Q10 = "Yes." Efficacy analyses were done with the MITT population which consisted of all randomized subjects who took at least 1 dose of double-blind treatment after the 2 in-clinic doses of double-blind medication and who had at least 1
Interventions
- DRUG bremelanotide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 612 participants |
| Start Date | 2011-06 |
| Est. Completion | 2012-09 |
| Phase | Phase 2 |
What the finished NCT01382719 record still lists
NCT01382719 is an interventional study that assigns participants to a tested intervention. The registered 612 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (360% higher).
The record links to 0 conditions, and to 1 intervention - of which bremelanotide is the first listed.
NCT01382719 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01382719 about?
NCT01382719 is a clinical study titled "Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder". This trial is designed to evaluate the efficacy and safety of 3 fixed dose levels of bremelanotide, administered subcutaneously on an as-needed basis under conditions of home use, for the treatment of female sexual arousal disorder (FSAD), hypoactive sexual desire disorder (HSDD), or mixed FSAD/HSDD...
What is the current status of trial NCT01382719?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 612 participants. The study started on 2011-06. Estimated completion is 2012-09.
What interventions are being tested in trial NCT01382719?
The interventions under investigation include: bremelanotide (DRUG).
Who is sponsoring clinical trial NCT01382719?
This trial is sponsored by Palatin Technologies, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01382719's enrollment target sits among peer trials
612 53rd of 2000 higher than 1,948 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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