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

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Atorvastatin
Placebo
Sponsored by
University of Oulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring PCOS, Atorvastatin, Androgens, Glucose metabolism, Inflammatory markers

Eligibility Criteria

30 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Obstetrics and Gynaecology, University of Oulu

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Atorvastatin

Placebo

Arm Description

6 months atorvastatin 20mg/day treatment

6 months placebo treatment

Outcomes

Primary Outcome Measures

Androgen secretion
Glucose metabolism

Secondary Outcome Measures

Inflammatory markers

Full Information

First Posted
February 18, 2010
Last Updated
September 6, 2011
Sponsor
University of Oulu
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01072097
Brief Title
The Effect of Atorvastatin on Androgens, Glucose Metabolism and Inflammation in Polycystic Ovary Syndrome (PCOS) Women
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 Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Oulu
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
PCOS, Atorvastatin, Androgens, Glucose metabolism, Inflammatory markers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Atorvastatin
Arm Type
Active Comparator
Arm Description
6 months atorvastatin 20mg/day treatment
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
6 months placebo treatment
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
Lipitor 20mg, Pfizer
Intervention Description
Atorvastatin 20mg/day for 6 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for 6 months
Primary Outcome Measure Information:
Title
Androgen secretion
Time Frame
0, 3, 6 months
Title
Glucose metabolism
Time Frame
0, (3), 6 months
Secondary Outcome Measure Information:
Title
Inflammatory markers
Time Frame
0, 3, 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terhi T. Piltonen, MD, PhD
Organizational Affiliation
Dept Ob-Gyn, University of Oulu
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Johanna Puurunen, MD
Organizational Affiliation
Dept Ob-Gyn, University of Oulu
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Juha S. Tapanainen, Professor
Organizational Affiliation
Dept Ob-Gyn, Univeristy of Oulu
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Obstetrics and Gynaecology, University of Oulu
City
Oulu
ZIP/Postal Code
90014
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
24152688
Citation
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.
Results Reference
derived

Learn more about this trial

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

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