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The Effect of Atorvastatin on Androgens, Glucose Metabolism and Inflammation in Polycystic Ovary Syndrome (PCOS) Women

Information source: University of Oulu
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Polycystic Ovary Syndrome

Intervention: Atorvastatin (Drug); Placebo (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Oulu

Official(s) and/or principal investigator(s):
Terhi T. Piltonen, MD, PhD, Study Director, Affiliation: Dept Ob-Gyn, University of Oulu
Johanna Puurunen, MD, Principal Investigator, Affiliation: Dept Ob-Gyn, University of Oulu
Juha S. Tapanainen, Professor, Study Chair, Affiliation: Dept Ob-Gyn, Univeristy of Oulu

Summary

This is a placebo controlled trial investigating the effect of 6 months atorvastatin 20mg/day therapy on androgens, glucose metabolism and inflammatory markers in women with PCOS. We assume that during 6 months atorvastatin therapy a significant improvement in hyperandrogenism, glucose metabolism and inflammatory markers is observed.

Clinical Details

Official title: The Effect of Atorvastatin on Androgen Synthesis, Glucose Metabolism and Inflammation in Women With Polycystic Ovary Syndrome (PCOS). A Placebo Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Androgen secretion

Glucose metabolism

Secondary outcome: Inflammatory markers

Detailed description: 30 women diagnosed for PCOS (aged 30-50 years) are enrolled for the study. 15 women are randomized in the atorvastatin group and 15 in the placebo group. The women with PCOS participating in the study are required to use safe non-hormonal contraception during the medication. The study includes transvaginal ultrasonography, serum samples, oral glucose tolerance test (OGTT) and intra venous tolerance test (IVGTT) before and after receiving 6 months atorvastatin 20mg/day therapy or placebo. Measurements for androgen levels, pituitary hormones, glucose, insulin and inflammatory markers are performed.

Eligibility

Minimum age: 30 Years. Maximum age: 50 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- diagnosed for PCOS (Rotterdam criteria)

- aged 30-50 years

- safe non-hormonal contraception

Exclusion Criteria:

- use of cholesterol lowering agents

- use of antidepressants

- use of cortisone medication (p. o.)

- use of hormonal contraception

- nursing

- pregnancy

- DM-T2

- liver disease

- menopause

- kidney or liver failure

Locations and Contacts

Department of Obstetrics and Gynaecology, University of Oulu, Oulu 90014, Finland
Additional Information

Starting date: September 2006
Last updated: September 6, 2011

Page last updated: August 23, 2015

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