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Completed

NCT Number: NCT01235754

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

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.

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Key information

Conditions

Hypoactive Sexual Desire Disorder Mental Disorders Sexual Dysfunctions, Psychological

Age range

30 year–66 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

BioSante Site# 123, Ottawa, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transdermal testosterone gel 1%

Drug

300 mcg once daily transdermal testosterone gel 1%

Other names: LibiGel transdermal testosterone gel 1%

Placebo Gel

Drug

once daily transdermal placebo gel

Other names: transdermal placebo gel

Primary outcomes

  1. 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

    Time frame: 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 outcomes

  1. change from baseline (previous study) in the mean FSDS-R question 13 score to week 12 of the current study

    Time frame: 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.

  2. 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

BioSante Pharmaceuticals

Industry

Registry information

Official study title

A Phase III, Multi-Center Extension Study to Assess Persistence of Benefit of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) in Surgically Menopausal Women

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Nov 8, 2010
Registry last updated
Jan 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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