Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation
NCT ID: NCT01103518
Last Updated: 2010-08-06
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
PHASE4
100 participants
INTERVENTIONAL
2009-12-31
2011-01-31
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
QUADRUPLE
Study Groups
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Combination 1
Ethinyl Estradiol + Cyproterone acetate
Ethinyl Estradiol + Cyproterone acetate
Ethinyl Estradiol (0.035mg) + Cyproterone acetate (2mg), coated tablets. Each treatment cycle consists of one tablet, once per day for 21 days followed by a 7-day rest period. A total of 4 treatment cycles will be completed during the study treatment period.
Combination 2
Ethinyl Estradiol + Cyproterone acetate
Ethinyl Estradiol + Cyproterone acetate
Ethinyl Estradiol (0.035mg) + Cyproterone acetate (2mg), coated tablets. Each treatment cycle consists of one tablet, once per day for 21 days followed by a 7-day rest period. A total of 4 treatment cycles will be completed during the study treatment period.
Interventions
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Ethinyl Estradiol + Cyproterone acetate
Ethinyl Estradiol (0.035mg) + Cyproterone acetate (2mg), coated tablets. Each treatment cycle consists of one tablet, once per day for 21 days followed by a 7-day rest period. A total of 4 treatment cycles will be completed during the study treatment period.
Eligibility Criteria
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Inclusion Criteria
* Premenopausal subject
* 18 years or older
* Medical history of irregular menses lasting at least 3 months
* Signature of informed consent
Exclusion Criteria
* Use of hormonal contraceptives within 3 months of screening
* Primary bilateral oophorectomy
* Chemotherapy and / or radiotherapy within 6 months of screening
* Hysterectomy
* Myotonic dystrophy
* Galactosemia
* Galactorrhea
* History of tuberculosis or schistosomiasis
* Elevated prolactin / other significant laboratory alterations
* Diabetes
* Premature ovarian deficiency
* Sensitivity to any component of the drug formula
18 Years
65 Years
FEMALE
No
Sponsors
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Fundação Educacional Serra dos Órgãos
OTHER
Responsible Party
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Fundação Educacional Serra dos Órgãos
Principal Investigators
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Carlos RB Gama, M.D.
Role: PRINCIPAL_INVESTIGATOR
Fundação Educacional Serra dos Órgãos
Carlos P Nunes, M.D.
Role: STUDY_DIRECTOR
Fundação Educacional Serra dos Órgãos
Locations
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Hospital das Clínicas de Teresópolis
Teresópolis, Rio de Janeiro, Brazil
Countries
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Other Identifiers
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AMI 1-16-08-09
Identifier Type: -
Identifier Source: org_study_id
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