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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


N/A
30 Years
50 Years
Not Enrolling
Female
Polycystic Ovary Syndrome

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Androgen secretion

Outcome Time Frame:

0, 3, 6 months

Safety Issue:

No

Principal Investigator

Terhi T. Piltonen, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Dept Ob-Gyn, University of Oulu

Authority:

Finland: Ethics Committee

Study ID:

85/2006

NCT ID:

NCT01072097

Start Date:

September 2006

Completion Date:

January 2011

Related Keywords:

  • Polycystic Ovary Syndrome
  • PCOS
  • Atorvastatin
  • Androgens
  • Glucose metabolism
  • Inflammatory markers
  • Inflammation
  • Polycystic Ovary Syndrome

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