Working… Menu
Trial record 23 of 25 for:    gestodene

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01372293
Recruitment Status : Completed
First Posted : June 13, 2011
Last Update Posted : September 12, 2011
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

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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: oral contraceptive pill Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2005
Actual Primary Completion Date : January 2008
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: oral contraceptive pill
    ethinyl oestradiol 20ug plus gestodene 75ug during 6 cycles

Primary Outcome Measures :
  1. Changes at Ferriman- Gallwey score [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Changes at testosterone levels [ Time Frame: 6 months ]
  2. Changes in lipid profile [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Denusa Wiltgen, MD,PhD, Federal University of Rio Grande do Sul Identifier: NCT01372293     History of Changes
Other Study ID Numbers: 04-245
First Posted: June 13, 2011    Key Record Dates
Last Update Posted: September 12, 2011
Last Verified: September 2011
Keywords provided by Denusa Wiltgen, Federal University of Rio Grande do Sul:
oral contraceptive pill
Additional relevant MeSH terms:
Layout table for MeSH terms
Polycystic Ovary Syndrome
Ovarian Cysts
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
Contraceptive Agents, Female