Status:
COMPLETED
Endometrial Safety Study of Transdermal Testosterone (300 Mcg/Day) in Naturally Postmenopausal Women
Lead Sponsor:
Warner Chilcott
Conditions:
Hypoactive Sexual Desire Disorder
Eligibility:
FEMALE
45-70 years
Phase:
PHASE3
Brief Summary
This study is designed to evaluate the endometrial safety of a testosterone patch as treatment for low libido in naturally postmenopausal women.
Detailed Description
Naturally postmenopausal women with hypoactive sexual desire disorder (HSDD) will be randomized into a 52-week, multicenter, double-blind (DB), parallel-group, placebo-controlled study. Patients will ...
Eligibility Criteria
Inclusion
- Women will be screened for study participation and must be at least one year post menopausal, 45-70 years old, in general good health, and may or may not be on hormone therapy, and must have low sexual desire which causes distress.
Exclusion
- Women will be screened for study participation and must not be using androgen therapy or have any medical, physical, psychological, or pharmacological condition that could make participation unsafe or confound the safety evaluation.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
1271 Patients enrolled
Trial Details
Trial ID
NCT00467259
Start Date
April 1 2007
End Date
January 1 2009
Last Update
December 15 2011
Active Locations (115)
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1
Study Facility
Birmingham, Alabama, United States, 35209
2
Research Facility
Birmingham, Alabama, United States, 35233
3
Research Facility
Mobile, Alabama, United States, 36617
4
Research Facility
Montgomery, Alabama, United States, 36116