71A/G HSD17B5 SNP and Effects of Oral Contraceptive Pill in PCOS Women

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome

• Registration Number: NCT01372293
• Lead Sponsor: Federal University of Rio Grande do Sul

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2008-01
• Study Completion: 2010-12
• Study First Submitted: 2011-06-10
• Study First Submitted QC: 2011-06-10
• Study First Posted: 2011-06-13
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-08
• Last Update Posted: 2011-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 49

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Changes at Ferriman- Gallwey score	6 months

Secondary Outcome Measures

Name	Time	Method
Changes at testosterone levels	6 months
Changes in lipid profile	6 months