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临床试验/NCT00955058
NCT00955058Unknown2 期

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

Shahid Beheshti University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2007年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
60
试验地点
1
主要终点
Serum free PSA was measured by ultrasensitive chemiluminnicsence enzyme immunoassay

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
22 Years 至 25 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • PCOS patients

排除标准

  • Women who received hormone therapy during the last 3 months,
  • On a diet
  • Herbal treatment
  • Hyperprolactinemia
  • Thyroid disorders
  • Ovarian tumors
  • Cushing disease.

研究组 & 干预措施

cyproterone compound

Active Comparator

Before and after treatment

干预措施: OCP (Drug)

oral contraceptive pill

Experimental

Treatment

干预措施: OCP (Drug)

结局指标

主要结局

Serum free PSA was measured by ultrasensitive chemiluminnicsence enzyme immunoassay

时间窗: 3 MONTHS

次要结局

  • Serum free testosterone was measured by ELISA and 17OHP and DHEAS were measured by radio-immunoassay and gamma scan test.(3 MONTHS)

研究者

申办方类型
Other

研究点 (1)

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