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

Completed · Phase 3 · Has a placebo group

Conditions studied: Hypoactive Sexual Desire Disorder

In brief

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).

Key facts

Study ID

NCT00612742

Run by

BioSante Pharmaceuticals

People needed

3656

Starts

2008-01-01

Expected to finish

2012-12-01

Last updated by the study team

2021-10-29

Who can join

Age: 50 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• BioSante Site 185 — Birmingham, Alabama, United States
• BioSante Site 095 — Hoover, Alabama, United States
• BioSante Site #014 — Huntsville, Alabama, United States
• BioSante Site 196 — Huntsville, Alabama, United States
• BioSante Site 146 — Mobile, Alabama, United States
• BioSante Site 171 — Chandler, Arizona, United States
• BioSante Site 145 — Glendale, Arizona, United States
• BioSante Site 027 — Glendale, Arizona, United States
• BioSante Site 121 — Phoenix, Arizona, United States
• BioSante Site 137 — Tucson, Arizona, United States
• BioSante Site 040 — Tucson, Arizona, United States
• BioSante Site 052 — Hot Springs, Arkansas, United States
• BioSante Site 100 — Jonesboro, Arkansas, United States
• BioSante Site #060 — Little Rock, Arkansas, United States
• BioSante Site 155 — Little Rock, Arkansas, United States
• BioSante Site 011 — Los Angeles, California, United States
• BioSante Site 094 — Palm Springs, California, United States
• BioSante Site 043 — Roseville, California, United States
• BioSante Site 162 — Sacramento, California, United States
• BioSante Site 025 — Sacramento, California, United States
• BioSante Site 112 — San Diego, California, United States
• BioSante Site 008 — San Diego, California, United States
• BioSante Site #070 — San Diego, California, United States
• BioSante Site 205 — San Diego, California, United States
• BioSante Site #215 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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