71A/G HSD17B5 SNP and Effects of Oral Contraceptive Pill in PCOS Women
17b-ACO
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
1 other identifier
interventional
49
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2005
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 10, 2011
CompletedFirst Posted
Study publicly available on registry
June 13, 2011
CompletedSeptember 12, 2011
September 1, 2011
3 years
June 10, 2011
September 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes at Ferriman- Gallwey score
6 months
Secondary Outcomes (2)
Changes at testosterone levels
6 months
Changes in lipid profile
6 months
Interventions
ethinyl oestradiol 20ug plus gestodene 75ug during 6 cycles
Eligibility Criteria
You may qualify if:
- hirsute women with polycystic ovary syndrome
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Maier PS, Mattiello SS, Lages L, Spritzer PM. 17-Hydroxysteroid dehydrogenase type 5 gene polymorphism (-71A/G HSD17B5 SNP) and treatment with oral contraceptive pills in PCOS women without metabolic comorbidities. Gynecol Endocrinol. 2012 Aug;28(8):606-10. doi: 10.3109/09513590.2011.650760. Epub 2012 Feb 14.
PMID: 22329763DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD,PhD
Study Record Dates
First Submitted
June 10, 2011
First Posted
June 13, 2011
Study Start
January 1, 2005
Primary Completion
January 1, 2008
Study Completion
December 1, 2010
Last Updated
September 12, 2011
Record last verified: 2011-09