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NCT00657501 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of LibiGel® for 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
- 575
- Enrollment target
- 20
- Study locations
NCT00657501 is a Phase 3 study of Hypoactive Sexual Desire Disorder that has completed, run by BioSante Pharmaceuticals. The registered enrollment target is 575 participants, above the 332-participant average among 8 other Hypoactive Sexual Desire Disorder trials with a reported enrollment target (73% higher). The trial reports 20 study locations across 8 states.
The verdict
NCT00657501, a Phase 3 study of Hypoactive Sexual Desire Disorder, has completed, sponsored by BioSante Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 575 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)
Arizona
- BioSante Site #171 - Chandler
- BioSante Site #145 - Glendale
- BioSante Site #121 - Phoenix
- BioSante Site #137 - Tucson
California
- BioSante Site #221 - Berkely
- BioSante Site #162 - Sacramento
- BioSante Site #112 - San Diego
- BioSante Site #159 - Walnut Creek
Connecticut
- BioSante Site #166 - Farmington
- BioSante Site #132 - New Britain
- BioSante Site #151 - New London
Florida
- BioSante Site #143 - Jacksonville
- BioSante Site #111 - Orlando
- BioSante Site #152 - Tampa
Arkansas
- BioSante Site #100 - Jonesboro
- BioSante Site #155 - Little Rock
Georgia
- BioSante Site #115 - Atlanta
- BioSante Site #141 - Roswell
Alabama
- BioSante Site #146 - Mobile
Colorado
- BioSante Site #026 - Lakewood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 575 participants |
| Start Date | 2008-03 |
| Est. Completion | 2011-09 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00657501
The ClinicalTrials.gov registry entry for NCT00657501 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 575 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 332-participant average among 8 other Hypoactive Sexual Desire Disorder trials with a reported enrollment target (73% 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.
NCT00657501 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Arizona, California, Connecticut.
Frequently Asked Questions
What is clinical trial NCT00657501 about?
NCT00657501 is a clinical study titled "Safety and Efficacy of LibiGel® for 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 NCT00657501?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 575 participants. The study started on 2008-03. Estimated completion is 2011-09.
What conditions does trial NCT00657501 study?
This clinical trial studies the following conditions: Hypoactive Sexual Desire Disorder.
What interventions are being tested in trial NCT00657501?
The interventions under investigation include: testosterone gel (DRUG), placebo gel (DRUG).
Who is sponsoring clinical trial NCT00657501?
This trial is sponsored by BioSante Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00657501 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
Similar trials for Hypoactive Sexual Desire Disorder
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Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women
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Read our methodology - how this data is sourced, computed, and verified.
Related
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