Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women (BLOOM)

BioSante Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Hypoactive Sexual Desire Disorder

Treatments: Drug: placebo gel; Drug: testosterone gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00657501

TESTW008

Details and patient eligibility

About

This study is a randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of LibiGel 300mcg in the treatment of HSDD in surgically menopausal women.

Enrollment: 575 patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must be between the ages of 30 to 65 years
• Must have undergone hysterectomy and bilateral salpingo-oophorectomy

Exclusion criteria

• A history of allergic reactions to androgens (oral or patch), topical alcohol, or any component of the formulation
• Any systemic skin diseases or local skin abnormalities in the area of application
• Diagnosed with another primary female sexual dysfunction (e.g., Sexual Aversion Disorder, Female Sexual Arousal Disorder).
• A medical condition that could affect or interfere with sexual function
• Using a systemic transdermal gel or cream estrogen therapy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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575 participants in 2 patient groups, including a placebo group

testosterone gel

Experimental group

Description:

1% testosterone transdermal gel

Treatment:

Drug: testosterone gel

Placebo gel

Placebo Comparator group

Description:

placebo transdermal gel

Treatment:

Drug: placebo gel