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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
History of Changes
  Purpose

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.


Condition Intervention
Polycystic Ovary Syndrome
 Drug: oral contraceptive pill

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of Rio Grande do Sul:

Primary Outcome Measures:
  • Changes at Ferriman- Gallwey score [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 49
Study Start Date: January 2005
Study Completion Date: December 2010
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: oral contraceptive pill
    ethinyl oestradiol 20ug plus gestodene 75ug during 6 cycles
  Eligibility

Ages Eligible for Study:   15 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided by Federal University of Rio Grande do Sul

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Denusa Wiltgen, MD,PhD, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT01372293     History of Changes
Other Study ID Numbers: 04-245
Study First Received: June 10, 2011
Last Updated: September 8, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Rio Grande do Sul:
PCOS
oral contraceptive pill
polymorphisms

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
 Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on May 16, 2013