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

Polycystic Ovary Syndrome Clinical Trial

Official title:

The Effect of Atorvastatin on Androgen Synthesis, Glucose Metabolism and Inflammation in Women With Polycystic Ovary Syndrome (PCOS). A Placebo Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01072097
• Other study ID #: 85/2006
• Status: Completed
• Phase: N/A
• First received: February 18, 2010
• Last updated: September 6, 2011
• Start date: September 2006
• Est. completion date: January 2011

Study information

• Verified date: September 2011
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics CommitteeFinland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Atorvastatin
Atorvastatin 20mg/day for 6 months
• Placebo
Placebo for 6 months

Locations

Country	Name	City	State
Finland	Department of Obstetrics and Gynaecology, University of Oulu	Oulu

Sponsors (2)

Lead Sponsor	Collaborator
University of Oulu	Pfizer

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Androgen secretion		0, 3, 6 months	No
Primary	Glucose metabolism		0, (3), 6 months	No
Secondary	Inflammatory markers		0, 3, 6 months	No