Clinical trial NCT01072097: 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
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: PCOS
Atorvastatin
Androgens
Glucose metabolism
Inflammatory markers
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2010-02-19
Enrollment: 30
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Androgen secretion
timeFrame: 0, 3, 6 months
measure: Glucose metabolism
timeFrame: 0, (3), 6 months
Secondary outcomes:
measure: Inflammatory markers
timeFrame: 0, 3, 6 months
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Department of Obstetrics and Gynaecology, University of Oulu
Study officials:
affiliation: Dept Ob-Gyn, University of Oulu
name: Terhi T. Piltonen, MD, PhD
role: STUDY_DIRECTOR
affiliation: Dept Ob-Gyn, University of Oulu
name: Johanna Puurunen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept Ob-Gyn, Univeristy of Oulu
name: Juha S. Tapanainen, Professor
role: STUDY_CHAIR
References:
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.