Testosterone Therapy in Naturally Menopausal Women With Low Sexual Desire Receiving Transdermal Estrogen
NCT ID: NCT00384046
Last Updated: 2013-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
272 participants
INTERVENTIONAL
2006-11-30
2007-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
300mcg/day testosterone
Testosterone
patch, 300 mcg/day testosterone, patch changed every 3-4 days, 24 weeks
2
Placebo arm
Placebo
patch, placebo, patch changed every 3-4 days, 24 weeks
Interventions
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Testosterone
patch, 300 mcg/day testosterone, patch changed every 3-4 days, 24 weeks
Placebo
patch, placebo, patch changed every 3-4 days, 24 weeks
Eligibility Criteria
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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.
40 Years
70 Years
FEMALE
No
Sponsors
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Warner Chilcott
INDUSTRY
Responsible Party
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Principal Investigators
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Imran A Lodhi, MD
Role: STUDY_DIRECTOR
Procter and Gamble
Locations
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Research Facility
Ashfield, New South Wales, Australia
Research Facility
Gordon, New South Wales, Australia
Research Facility
Randwick, New South Wales, Australia
Research Facility
Dulwich, South Australia, Australia
Research Facility
Prahran, Victoria, Australia
Research Facility
Nedlands, Western Australia, Australia
Research Facility
Freiburg, DEU, Botswana
Research Facility
Montreal, Quebec, Canada
Research Facility
Québec, Quebec, Canada
Research Facility
Münster, Münster, Germany
Research Facility
Aachen, , Germany
Research Facility
Hamburg, , Germany
Site Facility
Headington, Oxford, United Kingdom
Research Facility
Solihull, West Midlands, United Kingdom
Research Facility
Atherstone, , United Kingdom
Research Facility
Coventry, , United Kingdom
Research Facility
Doncaster, , United Kingdom
Research Facility
Headington, , 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
Warks, , United Kingdom
Countries
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Other Identifiers
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2005108
Identifier Type: -
Identifier Source: org_study_id
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