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NCT01235754 · ClinicalTrials.gov registry record · Phase 3
Extension Study to Assess Persistence of Benefit of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)
A Phase 3 study, sponsored by BioSante Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 626
- Enrollment target
NCT01235754: Completed Phase 3 study, sponsored by BioSante Pharmaceuticals.
NCT01235754 is a Phase 3 study that has completed, run by BioSante Pharmaceuticals. The registered enrollment target is 626 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01235754, a Phase 3 study, has completed, sponsored by BioSante Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 626 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the persistence of benefit of LibiGel (testosterone gel) 300 mcg/day compared to placebo gel in a 12 week post-treatment period of Hypoactive Sexual Desire Disorder (HSDD) in surgically menopausal women.
Primary Outcome
This study is to assess the persistence of benefit following the withdrawal of testosterone gel (LibiGel) in the treatment of Hypoactive Sexual Desire Disorder (HSDD) in healthy, surgically menopausal women.
Interventions
- DRUG placebo gel
- DRUG transdermal testosterone gel 1%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 626 participants |
| Start Date | 2010-10 |
| Est. Completion | 2012-01 |
| Phase | Phase 3 |
What the finished NCT01235754 record still lists
NCT01235754 is an interventional study that assigns participants to a tested intervention. The registered 626 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo gel is the first listed.
NCT01235754 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01235754 about?
NCT01235754 is a clinical study titled "Extension Study to Assess Persistence of Benefit of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)". The objective of this study is to evaluate the persistence of benefit of LibiGel (testosterone gel) 300 mcg/day compared to placebo gel in a 12 week post-treatment period of Hypoactive Sexual Desire Disorder (HSDD) in surgically menopausal women.
What is the current status of trial NCT01235754?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 626 participants. The study started on 2010-10. Estimated completion is 2012-01.
What interventions are being tested in trial NCT01235754?
The interventions under investigation include: placebo gel (DRUG), transdermal testosterone gel 1% (DRUG).
Who is sponsoring clinical trial NCT01235754?
This trial is sponsored by BioSante Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01235754's enrollment target sits among peer trials
626 586th of 2000 higher than 1,415 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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