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

NCT ID: NCT01372293

Last Updated: 2011-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2010-12-31

Brief Summary

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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

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Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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oral contraceptive pill

ethinyl oestradiol 20ug plus gestodene 75ug during 6 cycles

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role collaborator

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Federal University of Rio Grande do Sul

OTHER

Sponsor Role lead

Responsible Party

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Denusa Wiltgen

MD,PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 22329763 (View on PubMed)

Other Identifiers

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04-245

Identifier Type: -

Identifier Source: org_study_id

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