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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Drug: Atorvastatin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Atorvastatin<br>6 months atorvastatin 20mg/day treatment | Drug: Atorvastatin<br>* Atorvastatin 20mg/day for 6 months<br>* Other names: Lipitor 20mg, Pfizer;|
| Placebo Comparator: Placebo<br>6 months placebo treatment | Drug: Placebo<br>* Placebo for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Androgen secretion |  | 0, 3, 6 months | 
| Glucose metabolism |  | 0, (3), 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory markers |  | 0, 3, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCOS, Atorvastatin, Androgens, Glucose metabolism, Inflammatory markers