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

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.