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

Phase 3

Completed

• Conditions: Hypoactive Sexual Desire Disorder
• Interventions: Drug: testosterone gel; Drug: placebo gel

• Registration Number: NCT00612742
• Lead Sponsor: BioSante Pharmaceuticals

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-23
• Study First Submitted QC: 2008-01-30
• Study First Posted: 2008-02-12
• Primary Completion: 2012-10
• Study Completion: 2012-12
• Status Verified: 2021-10
• Disposition First Submitted: 2021-10-27
• Disposition First Submitted QC: 2021-10-27
• Last Update Submitted: 2021-10-27
• Disposition First Posted: 2021-10-29
• Last Update Posted: 2021-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3656

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
testosterone gel	testosterone gel	1% testosterone transdermal gel
placebo gel	placebo gel	placebo transdermal gel

Primary Outcome Measures

Name	Time	Method
The rate of adjudicated, predefined cardiovascular events in LibiGel-treated subjects compared to that of placebo-treated subjects.	2011 primary outcome analysis for NDA submission

Trial Locations

Locations (149)

BioSante Site #215; 🇺🇸 Birmingham, Alabama, United States

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

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