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

University of Oulu

Status: Completed

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Placebo; Drug: Atorvastatin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01072097

85/2006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 30 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Atorvastatin

Active Comparator group

Description:

6 months atorvastatin 20mg/day treatment

Treatment:

Drug: Atorvastatin

Placebo

Placebo Comparator group

Description:

6 months placebo treatment

Treatment:

Drug: Placebo