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

BioSante Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Hypoactive Sexual Desire Disorder

Treatments: Drug: testosterone gel; Drug: placebo gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00612742

TESTW007

Details and patient eligibility

About

This study is a randomized, double-blind, placebo-controlled, adaptive design, multi-center study of the long-term cardiovascular and breast safety of LibiGel in the treatment of HSDD in postmenopausal women with at least two points of cardiovascular risk and clinical diagnosis of Hypoactive Sexual Desire Disorder (HSDD).

Enrollment: 3,656 patients

Sex: Female

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Postmenopausal female subjects

• at least 50 years of age
• with at least two points of cardiovascular risk
• with a clinical diagnosis of HSDD.

Exclusion criteria

Subjects must not

• require treatment with anti-androgens, high-dose oral or injectable corticosteroids, tamoxifen or other selective estrogen receptor modulators,
• have used androgen therapy within 2 months of randomization,
• have a history of estrogen-dependent neoplasia or any gynecologic cancer,
• have a history of cancer of any kind in the past 10 years prior to randomization,
• have a history of malignant melanoma or a history of invasive cancer at any time,
• have a screening mammogram with any finding that requires follow up within 6 months of randomization,
• have a history of myocardial infarction, coronary revascularization or stroke within 12 months of randomization,
• have any medical condition associated with predicted survival of less than 3 years in the judgment of the Investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3,656 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