NCT01372293CompletedNot Applicable
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
Federal University of Rio Grande do Sul0 sites49 target enrollmentStarted: January 1, 2005Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 49
- Primary Endpoint
- Changes at Ferriman- Gallwey score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to 40 Years (Child, Adult)
- Sex
- 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
Outcomes
Primary Outcomes
Changes at Ferriman- Gallwey score
Time Frame: 6 months
Secondary Outcomes
- Changes at testosterone levels(6 months)
- Changes in lipid profile(6 months)
Investigators
Denusa Wiltgen
MD,PhD
Federal University of Rio Grande do Sul
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