Extension Study to Assess Persistence of Benefit of LibiG... | NCT01235754 | Trialant

Extension Study to Assess Persistence of Benefit of LibiG... | NCT01235754 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
placebo gel	Placebo Comparator	placebo transdermal gel	Drug: placebo gel
testosterone gel	Experimental	transdermal testosterone gel	Drug: transdermal testosterone gel 1%

Outcomes Module

Primary Outcomes

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 Outcomes

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

Contacts/Locations Module