search
Back to results

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

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
oral contraceptive pill
Sponsored by
Federal University of Rio Grande do Sul
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring PCOS, oral contraceptive pill, polymorphisms

Eligibility Criteria

15 Years - 40 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Changes at Ferriman- Gallwey score

    Secondary Outcome Measures

    Changes at testosterone levels
    Changes in lipid profile

    Full Information

    First Posted
    June 10, 2011
    Last Updated
    September 8, 2011
    Sponsor
    Federal University of Rio Grande do Sul
    Collaborators
    Hospital de Clinicas de Porto Alegre, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01372293
    Brief Title
    71A/G HSD17B5 SNP and Effects of Oral Contraceptive Pill in PCOS Women
    Acronym
    17b-ACO
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2005 (undefined)
    Primary Completion Date
    January 2008 (Actual)
    Study Completion Date
    December 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Rio Grande do Sul
    Collaborators
    Hospital de Clinicas de Porto Alegre, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Polycystic Ovary Syndrome
    Keywords
    PCOS, oral contraceptive pill, polymorphisms

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    49 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    oral contraceptive pill
    Intervention Description
    ethinyl oestradiol 20ug plus gestodene 75ug during 6 cycles
    Primary Outcome Measure Information:
    Title
    Changes at Ferriman- Gallwey score
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Changes at testosterone levels
    Time Frame
    6 months
    Title
    Changes in lipid profile
    Time Frame
    6 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22329763
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs