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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hypoactive Sexual Desire Disorder

Intervention / Treatment
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* Drug: transdermal testosterone gel 1%
* Drug: placebo gel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 66 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo gel<br>placebo transdermal gel | Drug: placebo gel<br>* once daily transdermal placebo gel<br>* Other names: transdermal placebo gel;|
| Experimental: testosterone gel<br>transdermal testosterone gel | Drug: transdermal testosterone gel 1%<br>* 300 mcg once daily transdermal testosterone gel 1%<br>* Other names: LibiGel transdermal testosterone gel 1%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline (previous study) in the mean FSDS-R question 13 score to week 12 of the current study | 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. | 12 weeks | 
| 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 | 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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testosterone, hypoactive sexual desire disorder, menopause