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

BioSante Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Hypoactive Sexual Desire Disorder

Treatments: Drug: placebo gel; Drug: transdermal testosterone gel 1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01235754

TESTW009

Details and patient eligibility

About

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.

Enrollment: 626 patients

Sex: Female

Ages: 30 to 66 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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626 participants in 2 patient groups, including a placebo group

placebo gel

Placebo Comparator group

Description:

placebo transdermal gel

Treatment:

Drug: placebo gel

testosterone gel

Experimental group

Description:

transdermal testosterone gel

Treatment:

Drug: transdermal testosterone gel 1%