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

NCT01072097

Last updated date
Study Location
Department of Obstetrics and Gynaecology, University of Oulu
Oulu, , 90014, Finland
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Polycystic Ovary Syndrome
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
30-50 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- diagnosed for PCOS (Rotterdam criteria)

- aged 30-50 years

- safe non-hormonal contraception

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Polycystic Ovary Syndrome
Intervention  ICMJE
  • Drug: Atorvastatin
    Atorvastatin 20mg/day for 6 months
    Other Name: Lipitor 20mg, Pfizer
  • Drug: Placebo
    Placebo for 6 months
Study Arms  ICMJE
  • Active Comparator: Atorvastatin
    6 months atorvastatin 20mg/day treatment
    Intervention: Drug: Atorvastatin
  • Placebo Comparator: Placebo
    6 months placebo treatment
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: February 18, 2010)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 30 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01072097
Other Study ID Numbers  ICMJE 85/2006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Juha Tapanainen/Professor, Dept Ob-Gyn, University of Oulu
Study Sponsor  ICMJE University of Oulu
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Terhi T. Piltonen, MD, PhDDept Ob-Gyn, University of Oulu
Principal Investigator:Johanna Puurunen, MDDept Ob-Gyn, University of Oulu
Study Chair:Juha S. Tapanainen, ProfessorDept Ob-Gyn, Univeristy of Oulu
PRS Account University of Oulu
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP