Hypoactive Sexual Desire Disorder Clinical Trial
Official title:
24-Week Study to Evaluate the Efficacy/Safety of Transdermal Testosterone in Naturally Menopausal Women With Hypoactive Sexual Desire Disorder Receiving Systemic Transdermal Estrogen Therapy.
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 are on transdermal estrogen.
Status | Completed |
Enrollment | 272 |
Est. completion date | July 2007 |
Est. primary completion date | July 2007 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 40 Years to 70 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Research Facility | Ashfield | New South Wales |
Australia | Research Facility | Dulwich | South Australia |
Australia | Research Facility | Gordon | New South Wales |
Australia | Research Facility | Nedlands | Western Australia |
Australia | Research Facility | Prahran | Victoria |
Australia | Research Facility | Randwick | New South Wales |
Botswana | Research Facility | Freiburg | DEU |
Canada | Research Facility | Montréal | Quebec |
Canada | Research Facility | Quebec City | Quebec |
Germany | Research Facility | Aachen | |
Germany | Research Facility | Hamburg | |
Germany | Research Facility | Münster | |
United Kingdom | Research Facility | Atherstone | |
United Kingdom | Research Facility | Coventry | |
United Kingdom | Research Facility | Doncaster | |
United Kingdom | Research Facility | Headington | |
United Kingdom | Site Facility | Headington | Oxford |
United Kingdom | Research Facility | Herts | |
United Kingdom | Research Facility | Leicester | |
United Kingdom | Research Facility | Leicester | |
United Kingdom | Research Facility | Lichfield | |
United Kingdom | Research Facility | London | |
United Kingdom | Research Facility | London | |
United Kingdom | Research Facility | London | |
United Kingdom | Research Facility | London | |
United Kingdom | Research Facility | London | |
United Kingdom | Research Facility | London | |
United Kingdom | Research Facility | Plymouth | |
United Kingdom | Research Facility | Salford | |
United Kingdom | Research Facility | Solihull | West Midlands |
United Kingdom | Research Facility | Warks |
Lead Sponsor | Collaborator |
---|---|
Warner Chilcott |
Australia, Botswana, Canada, Germany, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess the efficacy of the TTS by measuring change in frequency of total satisfying episodes. The safety assessment of TTS with various parameters. | Assessment at 12 and 24 weeks | No | |
Secondary | To assess the efficacy of the TTS as measured by the following parameters: changes in sexual desire, personal distress, and other domains of PFSF and SAL questionnaires. | Assessment at 12 and 24 weeks | No |
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