Status:
COMPLETED
Testosterone Therapy in Naturally Menopausal Women With Low Sexual Desire Receiving Transdermal Estrogen
Lead Sponsor:
Warner Chilcott
Conditions:
Hypoactive Sexual Desire Disorder
Eligibility:
FEMALE
40-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to examine whether the transdermal testosterone system (TTS) is effective and safe in the treatment of hypoactive sexual desire disorder (HSDD) in postmenopausal women who...
Detailed Description
This is a randomised, double-blind, placebo-controlled, parallel-group, multicentre, 24 week study to be conducted in approximately 300 patients at approximately 14 clinical sites in the UK, 6 sites i...
Eligibility Criteria
Inclusion
- Women will be screened for study participation according to the following inclusion criteria at Week -4. Eligible women must be a woman one year post menopausal, 40-70 years old in general good health on transdermal HRT and in a stable monogamous sexual relationship with low sexual desire causing distress.
Exclusion
- Women will be screened for study participation according to the following exclusion criteria at Week -4 or as specified. Eligible women must not have any medical, physical, psychological, or pharmacological condition that could confound safety or efficacy.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
272 Patients enrolled
Trial Details
Trial ID
NCT00384046
Start Date
November 1 2006
End Date
July 1 2007
Last Update
April 17 2013
Active Locations (31)
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1
Research Facility
Ashfield, New South Wales, Australia, 2131
2
Research Facility
Gordon, New South Wales, Australia, 2072
3
Research Facility
Randwick, New South Wales, Australia, 2031
4
Research Facility
Dulwich, South Australia, Australia, 5065