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NCT00612742 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women
A Phase 3 study, sponsored by BioSante Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,656
- Enrollment target
NCT00612742 is a Phase 3 study that has completed, run by BioSante Pharmaceuticals. The registered enrollment target is 3,656 participants.
The verdict
NCT00612742, a Phase 3 study, has completed, sponsored by BioSante Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,656 participants
- Enrollment target
Study Summary
This study is a randomized, double-blind, placebo-controlled, adaptive design, multi-center study of the long-term cardiovascular and breast safety of LibiGel in the treatment of HSDD in postmenopausal women with at least two points of cardiovascular risk and clinical diagnosis of Hypoactive Sexual Desire Disorder (HSDD).
Interventions
- DRUG testosterone gel
- DRUG placebo gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,656 participants |
| Start Date | 2008-01 |
| Est. Completion | 2012-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00612742
The ClinicalTrials.gov registry entry for NCT00612742 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 3,656 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 testosterone gel is the first listed.
NCT00612742 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00612742 about?
NCT00612742 is a clinical study titled "Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women". This study is a randomized, double-blind, placebo-controlled, adaptive design, multi-center study of the long-term cardiovascular and breast safety of LibiGel in the treatment of HSDD in postmenopausal women with at least two points of cardiovascular risk and clinical diagnosis of Hypoactive Sexual ...
What is the current status of trial NCT00612742?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,656 participants. The study started on 2008-01. Estimated completion is 2012-12.
What interventions are being tested in trial NCT00612742?
The interventions under investigation include: testosterone gel (DRUG), placebo gel (DRUG).
Who is sponsoring clinical trial NCT00612742?
This trial is sponsored by BioSante Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
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