Evaluation of Serum Prostatic Specific Antigen (PSA) After Cyproterone Compound Treatment Compared With Oral Contraceptives Pill in Hirsute Polycystic Ovary Syndrome Patients (PSA)
Primary Purpose
Polycystic Ovary Syndrome
Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
OCP
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring PSA, PCO, PCOS
Eligibility Criteria
Inclusion Criteria:
- PCOS patients
Exclusion Criteria:
- Women who received hormone therapy during the last 3 months,
- On a diet
- Herbal treatment
- Hyperprolactinemia
- Thyroid disorders
- Ovarian tumors
- Cushing disease.
Sites / Locations
- Taheripanah
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
cyproterone compound
oral contraceptive pill
Arm Description
Before and after treatment
Treatment
Outcomes
Primary Outcome Measures
Serum free PSA was measured by ultrasensitive chemiluminnicsence enzyme immunoassay
Secondary Outcome Measures
Serum free testosterone was measured by ELISA and 17OHP and DHEAS were measured by radio-immunoassay and gamma scan test.
Full Information
NCT ID
NCT00955058
First Posted
August 4, 2009
Last Updated
September 1, 2009
Sponsor
Shahid Beheshti University
1. Study Identification
Unique Protocol Identification Number
NCT00955058
Brief Title
Evaluation of Serum Prostatic Specific Antigen (PSA) After Cyproterone Compound Treatment Compared With Oral Contraceptives Pill in Hirsute Polycystic Ovary Syndrome Patients
Acronym
PSA
Official Title
Study of Serum Prostatic Specific Antigen (PSA) After Cyproterone Compound Treatment Compared With Oral Contraceptives Pill in Hirsute Polycystic Ovary Syndrome Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
February 2007 (undefined)
Primary Completion Date
February 2007 (Anticipated)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Shahid Beheshti University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effect of oral contraceptive on the serum free prostatic specific antigen (PSA)in women with polycystic ovary syndrome(PCOD)compared with cyproterone compound.
Detailed Description
The purpose of this study is to evaluate the effect of oral contraceptive on the serum free prostatic specific antigen (PSA)in women with polycystic ovary syndrome(PCOD)compared with cyproterone compound.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
PSA, PCO, PCOS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cyproterone compound
Arm Type
Active Comparator
Arm Description
Before and after treatment
Arm Title
oral contraceptive pill
Arm Type
Experimental
Arm Description
Treatment
Intervention Type
Drug
Intervention Name(s)
OCP
Intervention Description
Daily For 3 months
Primary Outcome Measure Information:
Title
Serum free PSA was measured by ultrasensitive chemiluminnicsence enzyme immunoassay
Time Frame
3 MONTHS
Secondary Outcome Measure Information:
Title
Serum free testosterone was measured by ELISA and 17OHP and DHEAS were measured by radio-immunoassay and gamma scan test.
Time Frame
3 MONTHS
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
PCOS patients
Exclusion Criteria:
Women who received hormone therapy during the last 3 months,
On a diet
Herbal treatment
Hyperprolactinemia
Thyroid disorders
Ovarian tumors
Cushing disease.
Facility Information:
Facility Name
Taheripanah
City
Tehran
ZIP/Postal Code
14137
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Serum Prostatic Specific Antigen (PSA) After Cyproterone Compound Treatment Compared With Oral Contraceptives Pill in Hirsute Polycystic Ovary Syndrome Patients
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