A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Long-Term Safety and Efficacy of LibiGel® for the 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.