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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01072097

Enrollment

Registered

2010-02-19

Start date

2006-09-30

Completion date

2011-01-31

Last updated

2011-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Keywords

PCOS, Atorvastatin, Androgens, Glucose metabolism, Inflammatory markers

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.

Interventions

DRUGAtorvastatin

Atorvastatin 20mg/day for 6 months

DRUGPlacebo

Placebo for 6 months

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 50 Years

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

Design outcomes

Primary

Measure	Time frame
Androgen secretion	0, 3, 6 months
Glucose metabolism	0, (3), 6 months

Secondary

Measure	Time frame
Inflammatory markers	0, 3, 6 months

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026