Evaluation of Serum Prostatic Specific Antigen (PSA) After Cyproterone Compound Treatment Compared With Oral Contraceptives Pill in Hirsute Polycystic Ovary Syndrome Patients
NCT ID: NCT00955058
Last Updated: 2009-09-03
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
PHASE2/PHASE3
60 participants
INTERVENTIONAL
2007-02-28
2010-12-31
Brief Summary
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Detailed Description
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This randomized clinical trial included 60 polycystic ovary syndrome patients with hirsutism who were referred to infertility and reproductive health research center and governmental public educational hospital from Feb2007 till Dec 2007. Polycystic ovary syndrome was defined as the diagnostic criteria of 2003 census Rotterdam. Hirsutism was defined as the presence of excessive hair in body and Ferriman -Gallway scores more than 7. Women who received hormone therapy during the last 3 months, on a diet or herbal treatment were excluded from the study. The other exclusion criterion's consisted of Hyperprolactinemia, thyroid disorders, ovarian tumors and Cushing disease. Hirsutism was determined by the Ferriman-Gallway score and recorded for every patient. Blood samples for serum PSA, and the hormonal profile including free testosterone, dehydroepiandrostenedione sulfate(DHEAS) and 17-hydroxyprogesterone(17-OHP) were taken at baseline and at the end of the treatment at the early follicular phase between 3th to 5th days of menstrual cycle at 8 AM. Patients were divided randomly in two treatment groups according to the computer based table. one group received oral contraceptive pills and the other one received cyproterone acetate combined ethinyl-estradiol(Diane) for 3 months. Hirsutism score was evaluated after treatment again. The blood samples were taken during the early follicular phase after 3 months of treatment to avoid pharmacological effect of treatment and serum PSA, free testosterone, DHEAS,17-OHP were measured again. The university ethics committee approved the study and the informed consent was obtained from patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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cyproterone compound
Before and after treatment
OCP
Daily For 3 months
oral contraceptive pill
Treatment
OCP
Daily For 3 months
Interventions
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OCP
Daily For 3 months
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* On a diet
* Herbal treatment
* Hyperprolactinemia
* Thyroid disorders
* Ovarian tumors
* Cushing disease.
22 Years
25 Years
FEMALE
Yes
Sponsors
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Shahid Beheshti University
OTHER
Responsible Party
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IRRC
Locations
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Taheripanah
Tehran, Tehran Province, Iran
Countries
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Other Identifiers
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PSA
Identifier Type: -
Identifier Source: org_study_id
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