Evaluation of Serum Prostatic Specific Antigen (PSA) After Cyproterone Compound Treatment Compared With Oral Contraceptives Pill in Hirsute Polycystic Ovary Syndrome Patients

This study is enrolling participants by invitation only.

Sponsor:

Information provided by:

Shahid Beheshti University

ClinicalTrials.gov Identifier:

NCT00955058

First received: August 4, 2009

Last updated: September 1, 2009

Last verified: September 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	August 4, 2009
Last Updated Date	September 1, 2009
Start Date ^ICMJE	February 2007
Estimated Primary Completion Date	February 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 6, 2009)	Serum free PSA was measured by ultrasensitive chemiluminnicsence enzyme immunoassay [ Time Frame: 3 MONTHS ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00955058 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 6, 2009)	Serum free testosterone was measured by ELISA and 17OHP and DHEAS were measured by radio-immunoassay and gamma scan test. [ Time Frame: 3 MONTHS ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Evaluation of Serum Prostatic Specific Antigen (PSA) After Cyproterone Compound Treatment Compared With Oral Contraceptives Pill in Hirsute Polycystic Ovary Syndrome Patients
Official Title ^ICMJE	Study of Serum Prostatic Specific Antigen (PSA) After Cyproterone Compound Treatment Compared With Oral Contraceptives Pill in Hirsute Polycystic Ovary Syndrome Patients
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2 Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Polycystic Ovary Syndrome
Intervention ^ICMJE	Drug: OCP Daily For 3 months
Study Arm (s)	Active Comparator: cyproterone compound Before and after treatment Intervention: Drug: OCP Experimental: oral contraceptive pill Treatment Intervention: Drug: OCP
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	60
Estimated Completion Date	December 2010
Estimated Primary Completion Date	February 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Female
Ages	22 Years to 25 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Iran, Islamic Republic of

Administrative Information
NCT Number ^ICMJE	NCT00955058
Other Study ID Numbers ^ICMJE	PSA, ----
Has Data Monitoring Committee	Yes
Responsible Party	IRHRC, IRRC
Study Sponsor ^ICMJE	Shahid Beheshti University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Shahid Beheshti University
Verification Date	September 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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