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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 is a Phase 3 study that has completed, run by BioSante Pharmaceuticals. The registered enrollment target is 626 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01235754
The ClinicalTrials.gov registry entry for NCT01235754 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 626 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioSante Pharmaceuticals, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo gel is the first listed.
NCT01235754 reports 0 study locations.
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.
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