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

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ClinicalTrials.gov Identifier: NCT01235754
Recruitment Status : Completed
First Posted : November 8, 2010
Last Update Posted : January 10, 2013
Sponsor:
Information provided by (Responsible Party):
BioSante Pharmaceuticals

November 4, 2010
November 8, 2010
January 10, 2013
October 2010
December 2011   (Final data collection date for primary outcome measure)
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.
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.
Complete list of historical versions of study NCT01235754 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
Not Provided
Not Provided
 
Extension Study to Assess Persistence of Benefit of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypoactive Sexual Desire Disorder
  • Drug: transdermal testosterone gel 1%
    300 mcg once daily transdermal testosterone gel 1%
    Other Name: LibiGel transdermal testosterone gel 1%
  • Drug: placebo gel
    once daily transdermal placebo gel
    Other Name: transdermal placebo gel
  • Placebo Comparator: placebo gel
    placebo transdermal gel
    Intervention: Drug: placebo gel
  • Experimental: testosterone gel
    transdermal testosterone gel
    Intervention: Drug: transdermal testosterone gel 1%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
626
750
January 2012
December 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
30 Years to 66 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT01235754
TESTW009
No
Not Provided
Not Provided
BioSante Pharmaceuticals
BioSante Pharmaceuticals
Not Provided
Study Director: Michael C Snabes, MD, PhD BioSante Pharmaceuticals
BioSante Pharmaceuticals
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP