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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

June 10, 2011
September 8, 2011
January 2005
January 2008   (final data collection date for primary outcome measure)
Changes at Ferriman- Gallwey score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01372293 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
71A/G HSD17B5 SNP and Effects of Oral Contraceptive Pill in PCOS Women
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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Polycystic Ovary Syndrome
Drug: oral contraceptive pill
ethinyl oestradiol 20ug plus gestodene 75ug during 6 cycles
Not Provided
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.
 
Completed
49
December 2010
January 2008   (final data collection date for primary outcome measure)

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
Female
15 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01372293
04-245
No
Denusa Wiltgen, Federal University of Rio Grande do Sul
Federal University of Rio Grande do Sul
  • Hospital de Clinicas de Porto Alegre
  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
Not Provided
Federal University of Rio Grande do Sul
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP