Effects of Fenofibrate on Metabolic and Reproductive Parameters in Polycystic Ovary Syndrome

Polycystic Ovary Syndrome Clinical Trial

Official title:

Effects of Fenofibrate on Metabolic and Reproductive Parameters in Polycystic Ovary Syndrome. A Randomized, Double-Blind, Placebo-Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00884819
• Other study ID #: R-08-573
• Secondary ID: 15581
• Status: Terminated
• Phase: N/A
• First received: April 20, 2009
• Last updated: April 1, 2015
• Start date: December 2008
• Est. completion date: February 2015

Study information

• Verified date: April 2015
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

This is a prospective randomized, double-blind placebo-controlled trial of 6 months' duration evaluating the effect of fenofibrate (200 mg/day) in females with polycystic ovary syndrome and mild hypertriglyceridemia. The investigators primary objective will be to determine whether fenofibrate will reduce hepatic adiposity as measured using MRI, and our secondary outcomes will be to delineate the impact of fenofibrate on biochemical or clinical parameters for insulin resistance, cardiovascular disease, and reproductive status.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• premenopausal women = 18 years

• diagnosis of PCOS based on the recent 2006 Androgen Excess Society criteria (modified from Rotterdam 2003)

• waist circumference >88 cm

• fasting TG 2.0 - 5.0 mmol/L

• stable on any type of oral contraceptive for a minimum of 3-months

Exclusion Criteria:

• known contraindications for MRI

• pregnancy, lactation, desire to become pregnant

• participation in another clinical trial

• fasting TF level = 5.0 mmol/L

• AST or ALT > 2.5 times upper limit of normal (ULN)

• creatinine kinase (CK) > 6x ULN

• creatinine > 115 µmol/L

• fasting glucose = 7.0 mmol/L and/or 2h glucose post oral glucose tolerance test (OGTT) = 11.1 mmol/L or personal history of DM2

• personal history of renal disease, liver disease (except NAFLD), or heart disease

• body mass index (BMI) < 18 or > 40 kg/m²

• increased alcohol use (>9 standard drinks per week [standard drink = 12oz beer, 5oz wine, or 1.5oz spirits]) or drug use

• use of other hormonal contraception, growth hormone, glucocorticoids, anti-diabetic/anti-dyslipidemia medications, or anabolic steroids.

Study Design

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Fenofibrate
fenofibrate 200 mg daily for 6-months

Other:
• Placebo
Placebo match for 6 months

Locations

Country	Name	City	State
Canada	St. Joseph's Health Care	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (5)

Idzior-Walus B, Sieradzki J, Rostworowski W, Zdzienicka A, Kawalec E, Wójcik J, Zarnecki A, Blane G. Effects of comicronised fenofibrate on lipid and insulin sensitivity in patients with polymetabolic syndrome X. Eur J Clin Invest. 2000 Oct;30(10):871-8. — View Citation

Lee HJ, Choi SS, Park MK, An YJ, Seo SY, Kim MC, Hong SH, Hwang TH, Kang DY, Garber AJ, Kim DK. Fenofibrate lowers abdominal and skeletal adiposity and improves insulin sensitivity in OLETF rats. Biochem Biophys Res Commun. 2002 Aug 16;296(2):293-9. — View Citation

Toda K, Okada T, Miyaura C, Saibara T. Fenofibrate, a ligand for PPARalpha, inhibits aromatase cytochrome P450 expression in the ovary of mouse. J Lipid Res. 2003 Feb;44(2):265-70. Epub 2002 Nov 4. — View Citation

Wysocki J, Belowski D, Kalina M, Kochanski L, Okopien B, Kalina Z. Effects of micronized fenofibrate on insulin resistance in patients with metabolic syndrome. Int J Clin Pharmacol Ther. 2004 Apr;42(4):212-7. — View Citation

Yong QW, Thavintharan S, Cheng A, Chew LS. The effect of fenofibrate on insulin sensitivity and plasma lipid profile in non-diabetic males with low high density lipoprotein/dyslipidaemic syndrome. Ann Acad Med Singapore. 1999 Nov;28(6):778-82. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatic adiposity as assessed using MRI		6-months	No
Secondary	Body composition using bioelectrical impedance analysis (BIA), anthropometry (skin-fold thickness measurement), and MRI		6-months	No
Secondary	Insulin resistance using HOMA-IR		6 months	No
Secondary	Biochemical parameters related to insulin resistance (adipocytokines, free fatty acids, 25-hydroxyvitamin D)		6 months	No
Secondary	Traditional and non-traditional cardiovascular risk factors (lipids, apolipoproteins, fibrinogen, PAI-1, CRP)		6 months	No
Secondary	Reproductive parameters (androgens, hirsutism)		6 months	No