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

This study has been completed.

Sponsor:

Collaborators:

Hospital de Clinicas de Porto Alegre

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Information provided by (Responsible Party):

Denusa Wiltgen, Federal University of Rio Grande do Sul

ClinicalTrials.gov Identifier:

NCT01372293

First received: June 10, 2011

Last updated: September 8, 2011

Last verified: September 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	June 10, 2011
Last Updated Date	September 8, 2011
Start Date ^ICMJE	January 2005
Primary Completion Date	January 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 10, 2011)	Changes at Ferriman- Gallwey score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01372293 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 10, 2011)	Changes at testosterone levels [ Time Frame: 6 months ] [ Designated as safety issue: No ] Changes in lipid profile [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	71A/G HSD17B5 SNP and Effects of Oral Contraceptive Pill in PCOS Women
Official Title ^ICMJE	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
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Polycystic Ovary Syndrome
Intervention ^ICMJE	Drug: oral contraceptive pill ethinyl oestradiol 20ug plus gestodene 75ug during 6 cycles
Study Arm (s)	Not Provided
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	49
Completion Date	December 2010
Primary Completion Date	January 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	15 Years to 40 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01372293
Other Study ID Numbers ^ICMJE	04-245
Has Data Monitoring Committee	No
Responsible Party	Denusa Wiltgen, Federal University of Rio Grande do Sul
Study Sponsor ^ICMJE	Federal University of Rio Grande do Sul
Collaborators ^ICMJE	Hospital de Clinicas de Porto Alegre Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators ^ICMJE	Not Provided
Information Provided By	Federal University of Rio Grande do Sul
Verification Date	September 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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