Skip to main content
OpenTrials
Completed

NCT Number: NCT01372293

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

15 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oral contraceptive pill

Drug

ethinyl oestradiol 20ug plus gestodene 75ug during 6 cycles

Primary outcomes

  1. Changes at Ferriman- Gallwey score

    Time frame: 6 months

Secondary outcomes

  1. Changes at testosterone levels

    Time frame: 6 months

  2. Changes in lipid profile

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Federal University of Rio Grande do Sul

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  • Hospital de Clinicas de Porto Alegre

Registry information

Official study 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

Acronym: 17b-ACO

Important dates

Study start
2005
Primary completion
2008
Study completion
2010
First posted
Jun 13, 2011
Registry last updated
Sep 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.