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 ofrandomization,
• 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 inthe judgment of the Investigator.