Trial record 15 of 62 for:    Polycystic Ovary Syndrome: Clinical Trials

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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
University of Oulu
ClinicalTrials.gov Identifier:
NCT01072097
First received: February 18, 2010
Last updated: September 6, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention
Polycystic Ovary Syndrome
Drug: Atorvastatin
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Atorvastatin on Androgen Synthesis, Glucose Metabolism and Inflammation in Women With Polycystic Ovary Syndrome (PCOS). A Placebo Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • Androgen secretion [ Time Frame: 0, 3, 6 months ] [ Designated as safety issue: No ]
  • Glucose metabolism [ Time Frame: 0, (3), 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inflammatory markers [ Time Frame: 0, 3, 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2006
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Atorvastatin
6 months atorvastatin 20mg/day treatment
Drug: Atorvastatin
Atorvastatin 20mg/day for 6 months
Other Name: Lipitor 20mg, Pfizer
Placebo Comparator: Placebo
6 months placebo treatment
Drug: Placebo
Placebo for 6 months

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

Ages Eligible for Study:   30 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01072097

Locations
Finland
Department of Obstetrics and Gynaecology, University of Oulu
Oulu, Finland, 90014
Sponsors and Collaborators
University of Oulu
Pfizer
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
  More Information

No publications provided by University of Oulu

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Juha Tapanainen/Professor, Dept Ob-Gyn, University of Oulu
ClinicalTrials.gov Identifier: NCT01072097     History of Changes
Other Study ID Numbers: 85/2006
Study First Received: February 18, 2010
Last Updated: September 6, 2011
Health Authority: Finland: Ethics Committee
Finland: Finnish Medicines Agency

Keywords provided by University of Oulu:
PCOS
Atorvastatin
Androgens
Glucose metabolism
Inflammatory markers

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Inflammation
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Androgens
Atorvastatin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014