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NCT00613002 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women
A Phase 3 study of Hypoactive Sexual Desire Disorder, sponsored by BioSante Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 597
- Enrollment target
- 20
- Study locations
NCT00613002 is a Phase 3 study of Hypoactive Sexual Desire Disorder that has completed, run by BioSante Pharmaceuticals. The registered enrollment target is 597 participants, above the 329-participant average among 8 other Hypoactive Sexual Desire Disorder trials with a reported enrollment target (81% higher). The trial reports 20 study locations across 12 states.
The verdict
NCT00613002, a Phase 3 study of Hypoactive Sexual Desire Disorder, has completed, sponsored by BioSante Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 597 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is a randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of LibiGel® 300mcg in the treatment of HSDD in surgically menopausal women
Conditions Studied
Interventions
- DRUG testosterone gel
- DRUG placebo gel
Study Locations (20)
Florida
- BioSante Site #024 - Miami
- BioSante Site #219 - Pinellas Park
- BioSante Site #041 - St. Petersburg
- BioSante Site #009 - West Palm Beach
Alabama
- BioSante Site #215 - Birmingham
- BioSante Site #095 - Hoover
- BioSante Site #014 - Huntsville
Arizona
- BioSante Site #027 - Glendale
- BioSante Site #040 - Tucson
California
- BioSante Site #182 - Buena Park
- BioSante Site #008 - San Diego
Colorado
- BioSante Site #007 - Denver
- BioSante Site #216 - Denver
Arkansas
- BioSante Site #052 - Hot Springs
Connecticut
- BioSante Site #036 - Ridgefield
District of Columbia
- BioSante Site #013 - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 597 participants |
| Start Date | 2006-12 |
| Est. Completion | 2011-09 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00613002
The ClinicalTrials.gov registry entry for NCT00613002 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 597 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 329-participant average among 8 other Hypoactive Sexual Desire Disorder trials with a reported enrollment target (81% higher). The listed sponsor is BioSante Pharmaceuticals, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hypoactive Sexual Desire Disorder appearing as the primary indexed condition, and to 2 interventions - of which testosterone gel is the first listed.
NCT00613002 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Florida, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT00613002 about?
NCT00613002 is a clinical study titled "Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women". This study is a randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of LibiGel® 300mcg in the treatment of HSDD in surgically menopausal women
What is the current status of trial NCT00613002?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 597 participants. The study started on 2006-12. Estimated completion is 2011-09.
What conditions does trial NCT00613002 study?
This clinical trial studies the following conditions: Hypoactive Sexual Desire Disorder.
What interventions are being tested in trial NCT00613002?
The interventions under investigation include: testosterone gel (DRUG), placebo gel (DRUG).
Who is sponsoring clinical trial NCT00613002?
This trial is sponsored by BioSante Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00613002 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
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