71A/G HSD17B5 SNP and Effects of Oral Contraceptive Pill in PCOS Women (17b-ACO)

September 8, 2011 updated by: Denusa Wiltgen, Federal University of Rio Grande do Sul

17-hydroxysteroid Dehydrogenase Type 5 Gene Polymorphism (71A/G HSD17B5 SNP) and Effects of Oral Contraceptive Pill on Hirsutism, Androgens and Metabolic Profile in Non-obese PCOS Women: a Pilot Study

An association of the single nucleotide polymorphism (SNP) in the promoter gene that codify for 17b-HSD5 enzyme (71A>G) with polycystic ovary syndrome (PCOS) and hyperandrogenemia has been suggested in previous studies.

Given the role of 17b-HSD5 in androgenic metabolism producing testosterone from precursors, the investigators hypothesis is that women with PCOS and with the variant allele G have a poor response on hirsutism and on hormonal and metabolic variables after oral contraceptive pill (OCP) treatment for 6 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • hirsute women with polycystic ovary syndrome

Exclusion Criteria:

  • Use of any drugs known to interfere with hormone levels for at least 3 months before the study
  • Women with type 2 diabetes, homa index > 3.8, liver or renal disease or thyroid dysfunction
  • Other hyperandrogenic disorders than PCOS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes at Ferriman- Gallwey score
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes at testosterone levels
Time Frame: 6 months
6 months
Changes in lipid profile
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Rio Grande do Sul

Collaborators

Hospital de Clinicas de Porto Alegre
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Conselho Nacional de Desenvolvimento Científico e Tecnológico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

June 10, 2011

First Submitted That Met QC Criteria

June 10, 2011

First Posted (Estimate)

June 13, 2011

Study Record Updates

Last Update Posted (Estimate)

September 12, 2011

Last Update Submitted That Met QC Criteria

September 8, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-245

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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