Trial Information

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

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.