Extension Study to Assess Persistence of Benefit of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)

Phase 3

Completed

• Conditions: Hypoactive Sexual Desire Disorder
• Interventions: Drug: placebo gel; Drug: transdermal testosterone gel 1%

• Registration Number: NCT01235754
• Lead Sponsor: BioSante Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-11-04
• Study First Submitted QC: 2010-11-05
• Study First Posted: 2010-11-07
• Primary Completion: 2011-12
• Study Completion: 2012-01
• Status Verified: 2013-01
• Disposition First Submitted: 2013-01-04
• Disposition First Submitted QC: 2013-01-04
• Last Update Submitted: 2013-01-04
• Disposition First Posted: 2013-01-10
• Last Update Posted: 2013-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 626

Inclusion Criteria

• must have completed a minimum of 22 weeks of the 24-week TESTW006 or TESTW008 clinical trial

Exclusion Criteria

• Any condition (including a change in sexual or relationship history) that would make the subject unsuitable for participation in the trial in the opinion of the Investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo gel	placebo gel	placebo transdermal gel
testosterone gel	transdermal testosterone gel 1%	transdermal testosterone gel

Primary Outcome Measures

Name	Time	Method
Change in the 4-week total number of days with at least one satisfying sexual event from the baseline period (during the previous study) to weeks 9-12 of the current study	12 weeks	This study is to assess the persistence of benefit following the withdrawal of testosterone gel (LibiGel) in the treatment of Hypoactive Sexual Desire Disorder (HSDD) in healthy, surgically menopausal women.

Secondary Outcome Measures

Name	Time	Method
change from baseline (previous study) in the mean FSDS-R question 13 score to week 12 of the current study	12 weeks	This study is to acess the persistence of benefit following the withdrawal of testosterone gel 1% (LibiGel)in the treatment of Hypoactive Sexual Desire Disorder (HSDD) in healthy, surgically menopausal women.
change from baseline (previous study) in the total number of days with at least one satisfying sexual event at weeks 4 and 8 of the current study	12 weeks	This study is to assess the persistence of benefit following the withdrawal of testosterone gel (LibiGel)in the treatment of Hypoactive Sexual Desire Disorder (HSDD) in healthy, surgically menopausal women.

Trial Locations

Locations (102)

BioSante Site #095; 🇺🇸 Hoover, Alabama, United States

BioSante Site #014; 🇺🇸 Huntsville, Alabama, United States

BioSante Site #146; 🇺🇸 Mobile, Alabama, United States

BioSante Site #171; 🇺🇸 Chandler, Arizona, United States

BioSante Site #145; 🇺🇸 Glendale, Arizona, United States

BioSante Site #027; 🇺🇸 Glendale, Arizona, United States

BioSante Site #121; 🇺🇸 Phoenix, Arizona, United States

BioSante Site #137; 🇺🇸 Tucson, Arizona, United States

BioSante Site #052; 🇺🇸 Hot Springs, Arkansas, United States

BioSante Site #155; 🇺🇸 Little Rock, Arkansas, United States

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