The Effect of Atorvastatin on Androgens, Glucose Metabolism and Inflammation in Polycystic Ovary Syndrome (PCOS) Women
Information source: University of Oulu
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Polycystic Ovary Syndrome
Intervention: Atorvastatin (Drug); Placebo (Drug)
Phase: N/A
Status: Completed
Sponsored by: University of Oulu Official(s) and/or principal investigator(s): Terhi T. Piltonen, MD, PhD, Study Director, Affiliation: Dept Ob-Gyn, University of Oulu Johanna Puurunen, MD, Principal Investigator, Affiliation: Dept Ob-Gyn, University of Oulu Juha S. Tapanainen, Professor, Study Chair, Affiliation: Dept Ob-Gyn, Univeristy of Oulu
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.
Clinical Details
Official title: The Effect of Atorvastatin on Androgen Synthesis, Glucose Metabolism and Inflammation in Women With Polycystic Ovary Syndrome (PCOS). A Placebo Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Androgen secretionGlucose metabolism
Secondary outcome: Inflammatory markers
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.
Eligibility
Minimum age: 30 Years.
Maximum age: 50 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Department of Obstetrics and Gynaecology, University of Oulu, Oulu 90014, Finland
Additional Information
Starting date: September 2006
Last updated: September 6, 2011
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