- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01072097
The Effect of Atorvastatin on Androgens, Glucose Metabolism and Inflammation in Polycystic Ovary Syndrome (PCOS) Women
The Effect of Atorvastatin on Androgen Synthesis, Glucose Metabolism and Inflammation in Women With Polycystic Ovary Syndrome (PCOS). A Placebo Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Oulu, Finland, 90014
- Department of Obstetrics and Gynaecology, University of Oulu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Atorvastatin
6 months atorvastatin 20mg/day treatment
|
Atorvastatin 20mg/day for 6 months
Other Names:
|
PLACEBO_COMPARATOR: Placebo
6 months placebo treatment
|
Placebo for 6 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Androgen secretion
Time Frame: 0, 3, 6 months
|
0, 3, 6 months
|
Glucose metabolism
Time Frame: 0, (3), 6 months
|
0, (3), 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Inflammatory markers
Time Frame: 0, 3, 6 months
|
0, 3, 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Terhi T. Piltonen, MD, PhD, Dept Ob-Gyn, University of Oulu
- Principal Investigator: Johanna Puurunen, MD, Dept Ob-Gyn, University of Oulu
- Study Chair: Juha S. Tapanainen, Professor, Dept Ob-Gyn, Univeristy of Oulu
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Endocrine System Diseases
- Disease
- Ovarian Cysts
- Cysts
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Polycystic Ovary Syndrome
- Syndrome
- Inflammation
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Atorvastatin
Other Study ID Numbers
- 85/2006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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