NCT00955058

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 7, 2009

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

September 3, 2009

Status Verified

September 1, 2009

Enrollment Period

Same day

First QC Date

August 4, 2009

Last Update Submit

September 1, 2009

Conditions

Polycystic Ovary Syndrome

Keywords

PSAPCOPCOS

Outcome Measures

Primary Outcomes (1)

  • Serum free PSA was measured by ultrasensitive chemiluminnicsence enzyme immunoassay

    3 MONTHS

Secondary Outcomes (1)

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

    3 MONTHS

Study Arms (2)

cyproterone compound

ACTIVE COMPARATOR

Before and after treatment

Drug: OCP

oral contraceptive pill

EXPERIMENTAL

Treatment

Drug: OCP

Interventions

OCPDRUG

Daily For 3 months

cyproterone compoundoral contraceptive pill

Eligibility Criteria

Age22 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • PCOS patients

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taheripanah

Tehran, Tehran Province, 14137, Iran

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 4, 2009

First Posted

August 7, 2009

Study Start

February 1, 2007

Primary Completion

February 1, 2007

Study Completion

December 1, 2010

Last Updated

September 3, 2009

Record last verified: 2009-09

Locations

IR(1)