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
  Purpose

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.


Condition Intervention Phase
Polycystic Ovary Syndrome
Drug: OCP
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Serum Prostatic Specific Antigen (PSA) After Cyproterone Compound Treatment Compared With Oral Contraceptives Pill in Hirsute Polycystic Ovary Syndrome Patients

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti University:

Primary Outcome Measures:
  • Serum free PSA was measured by ultrasensitive chemiluminnicsence enzyme immunoassay [ Time Frame: 3 MONTHS ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: February 2007
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: cyproterone compound
Before and after treatment
Drug: OCP
Daily For 3 months
Experimental: oral contraceptive pill
Treatment
Drug: OCP
Daily For 3 months

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.

  Eligibility

Ages Eligible for Study:   22 Years to 25 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955058

Locations
Iran, Islamic Republic of
Taheripanah
Tehran, Iran, Islamic Republic of, 14137
Sponsors and Collaborators
Shahid Beheshti University
  More Information

No publications provided

Responsible Party: IRHRC, IRRC
ClinicalTrials.gov Identifier: NCT00955058     History of Changes
Other Study ID Numbers: PSA, ----
Study First Received: August 4, 2009
Last Updated: September 1, 2009
Health Authority: Iran: Ethics Committee

Keywords provided by Shahid Beheshti University:
PSA
PCO
PCOS

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Syndrome
Adnexal Diseases
Cysts
Disease
Endocrine System Diseases
Genital Diseases, Female
Gonadal Disorders
Neoplasms
Ovarian Cysts
Ovarian Diseases
Pathologic Processes
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Cyproterone
Cyproterone Acetate
Androgen Antagonists
Antineoplastic Agents
Contraceptive Agents, Female
Contraceptive Agents, Male
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014