The Effects of Isoflavone and Estrogen in Sex Response in Climacteric Women
NCT ID: NCT00905723
Last Updated: 2009-05-20
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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UNKNOWN
PHASE3
60 participants
INTERVENTIONAL
2009-05-31
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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Estrogen
Women randomized to this group will receive daily pills containing 1 mg of estradiol
estradiol
1 mg daily for 6 months
Isoflavone
Women randomized to this group will receive daily pills of 150 mg isoflavone
isoflavone
150 mg isoflavone daily for 6 months
Placebo
Women randomized to this group will be administered daily placebo pills
Placebo
sugar pill daily for six months
Interventions
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estradiol
1 mg daily for 6 months
isoflavone
150 mg isoflavone daily for 6 months
Placebo
sugar pill daily for six months
Eligibility Criteria
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Inclusion Criteria
* presenting climacteric symptoms
* sexual complaints
Exclusion Criteria
* counter indication to hormonal therapy
* uncontrolled comorbidities
45 Years
65 Years
FEMALE
Yes
Sponsors
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Federal University of São Paulo
OTHER
Responsible Party
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Universidade Federal de São Paulo - Departamento de Ginecologia
Principal Investigators
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Mauro A Aidar, M.D., PhD
Role: STUDY_CHAIR
Universidade Federal de São Paulo
Locations
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Ambulatório de Ginecologia Endócrina
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Universidade Federal de São Paulo's web page
Other Identifiers
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0759/08
Identifier Type: -
Identifier Source: org_study_id
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