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

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).

• Drug: testosterone gel
  once daily transdermal testosterone gel, 300 mcg
  Other Name: LibiGel
• Drug: placebo gel
  once daily transdermal placebo gel
  Other Name: placebo gel

• Experimental: testosterone gel
  1% testosterone transdermal gel
  Intervention: Drug: testosterone gel
• Placebo Comparator: placebo gel
  placebo transdermal gel
  Intervention: Drug: placebo gel

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.