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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official 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 Menopausa

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 Summary:
Sponsor: BioSante Pharmaceuticals

Current Primary Outcome: 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.


Original Primary Outcome: 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 HSDD in healthy, surgically menopausal women.


Current Secondary Outcome:

  • 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.
  • 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.


Original Secondary Outcome:

  • 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 HSDD in healthy, surgically menopausal women.
  • change from baseline (previous study) in the total number of days with at least one staisfying 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 HSDD in healthy, surgically menopausal women.


Information By: BioSante Pharmaceuticals

Dates:
Date Received: November 4, 2010
Date Started: October 2010
Date Completion:
Last Updated: January 4, 2013
Last Verified: January 2013