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

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Placebo; Drug: Atorvastatin

• Registration Number: NCT01072097
• Lead Sponsor: University of Oulu

Brief 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.

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.

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2010-02-18
• Study First Submitted QC: 2010-02-18
• Study First Posted: 2010-02-19
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-06
• Last Update Posted: 2011-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	6 months placebo treatment
Atorvastatin	Atorvastatin	6 months atorvastatin 20mg/day treatment

Primary Outcome Measures

Name	Time	Method
Androgen secretion	0, 3, 6 months
Glucose metabolism	0, (3), 6 months

Secondary Outcome Measures

Name	Time	Method
Inflammatory markers	0, 3, 6 months

Trial Locations

Locations (1)

Department of Obstetrics and Gynaecology, University of Oulu; 🇫🇮 Oulu, Finland