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

Polycystic Ovary Syndrome Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01372293
• Other study ID #: 04-245
• Status: Completed
• Phase: N/A
• First received: June 10, 2011
• Last updated: September 8, 2011
• Start date: January 2005
• Est. completion date: December 2010

Study information

• Verified date: September 2011
• Source: Federal University of Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 2010
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 40 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Federal University of Rio Grande do Sul	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Hospital de Clinicas de Porto Alegre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes at Ferriman- Gallwey score		6 months	No
Secondary	Changes at testosterone levels		6 months	No
Secondary	Changes in lipid profile		6 months	No