Status:
COMPLETED
Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women
Lead Sponsor:
BioSante Pharmaceuticals
Conditions:
Hypoactive Sexual Desire Disorder
Eligibility:
FEMALE
50+ years
Phase:
PHASE3
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 postmenopausa...
Eligibility Criteria
Inclusion
- Postmenopausal female subjects
- at least 50 years of age
- with at least two points of cardiovascular risk
- with a clinical diagnosis of HSDD.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
3656 Patients enrolled
Trial Details
Trial ID
NCT00612742
Start Date
January 1 2008
End Date
December 1 2012
Last Update
October 29 2021
Active Locations (149)
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1
BioSante Site #215
Birmingham, Alabama, United States, 35209
2
BioSante Site 185
Birmingham, Alabama, United States, 35233
3
BioSante Site 095
Hoover, Alabama, United States, 35216
4
BioSante Site #014
Huntsville, Alabama, United States, 35801