Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study of Hypoactive Sexual Desire Disorder, sponsored by BioSante Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00657501 record still lists
NCT00657501 is an interventional study that assigns participants to a tested intervention. The registered 575 participants enrollment target is mid-sized for trials with a published cap, above the 332-participant average among 8 other Hypoactive Sexual Desire Disorder trials with a reported enrollment target (73% higher).
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 names 20 study sites across 8 states, led by 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
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00657501's enrollment target sits among peer trials
575 4th of 8 higher than 5 of 8 other Hypoactive Sexual Desire Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypoactive Sexual Desire Disorder 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
-
Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women
COMPLETED · Phase 3
-
2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder
COMPLETED · Phase 3
-
Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)
COMPLETED · Phase 3
-
Lybridos in Pre-and Postmenopausal Women With Hypoactive Sexual Desire Disorder
COMPLETED · Phase 2
-
A Mindfulness-based Intervention for Older Women With Low Sexual Desire
COMPLETED · NA
-
Lybridos in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder Due to Maladaptive Activation of Sexual Inhibitory Systems
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02610439 · 575 participants
Whole Exome Sequencing in Finding Causative Variants in Germline DNA Samples From Patients With Peripheral Neuropathy Receiving Paclitaxel for Breast Cancer
- NCT05919264 · 575 participants · Phase 1
FOG-001 in Locally Advanced or Metastatic Solid Tumors
- NCT06583148 · 575 participants · NA
A Smoke-Free Home Intervention in Tribal Communities
- NCT06883175 · 575 participants · NA
Evolution of the Chicago Classification: Bridging Physiology and Mechanics
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia