The Effect of Atorvastatin on Androgens, Glucose Metabolism and Inflammation in Polycystic Ovary Syndrome (PCOS) Women
NCT ID: NCT01072097
Last Updated: 2011-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2006-09-30
2011-01-31
Brief Summary
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We assume that during 6 months atorvastatin therapy a significant improvement in hyperandrogenism, glucose metabolism and inflammatory markers is observed.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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Atorvastatin
6 months atorvastatin 20mg/day treatment
Atorvastatin
Atorvastatin 20mg/day for 6 months
Placebo
6 months placebo treatment
Placebo
Placebo for 6 months
Interventions
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Atorvastatin
Atorvastatin 20mg/day for 6 months
Placebo
Placebo for 6 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* aged 30-50 years
* safe non-hormonal contraception
Exclusion Criteria
* use of antidepressants
* use of cortisone medication (p.o.)
* use of hormonal contraception
* nursing
* pregnancy
* DM-T2
* liver disease
* menopause
* kidney or liver failure
30 Years
50 Years
FEMALE
No
Sponsors
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Pfizer
INDUSTRY
University of Oulu
OTHER
Responsible Party
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Dept Ob-Gyn, University of Oulu
Principal Investigators
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Terhi T. Piltonen, MD, PhD
Role: STUDY_DIRECTOR
Dept Ob-Gyn, University of Oulu
Johanna Puurunen, MD
Role: PRINCIPAL_INVESTIGATOR
Dept Ob-Gyn, University of Oulu
Juha S. Tapanainen, Professor
Role: STUDY_CHAIR
Dept Ob-Gyn, Univeristy of Oulu
Locations
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Department of Obstetrics and Gynaecology, University of Oulu
Oulu, , Finland
Countries
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References
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Xiong T, Fraison E, Kolibianaki E, Costello MF, Venetis C, Kostova EB. Statins for women with polycystic ovary syndrome not actively trying to conceive. Cochrane Database Syst Rev. 2023 Jul 18;7(7):CD008565. doi: 10.1002/14651858.CD008565.pub3.
Puurunen J, Piltonen T, Puukka K, Ruokonen A, Savolainen MJ, Bloigu R, Morin-Papunen L, Tapanainen JS. Statin therapy worsens insulin sensitivity in women with polycystic ovary syndrome (PCOS): a prospective, randomized, double-blind, placebo-controlled study. J Clin Endocrinol Metab. 2013 Dec;98(12):4798-807. doi: 10.1210/jc.2013-2674. Epub 2013 Oct 23.
Other Identifiers
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85/2006
Identifier Type: -
Identifier Source: org_study_id
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