Effects of Fenofibrate on Metabolic and Reproductive Parameters in Polycystic Ovary Syndrome - Full Text View

Sponsor:	Lawson Health Research Institute
Information provided by:	Lawson Health Research Institute
ClinicalTrials.gov Identifier:	NCT00884819

Purpose

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.

Condition	Intervention
Polycystic Ovary Syndrome	Drug: Fenofibrate Other: Placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Effects of Fenofibrate on Metabolic and Reproductive Parameters in Polycystic Ovary Syndrome. A Randomized, Double-Blind, Placebo-Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines Obesity Polycystic Ovary Syndrome

Drug Information available for: Procetofen

U.S. FDA Resources

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:

Hepatic adiposity as assessed using MRI [ Time Frame: 6-months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Body composition using bioelectrical impedance analysis (BIA), anthropometry (skin-fold thickness measurement), and MRI [ Time Frame: 6-months ] [ Designated as safety issue: No ]
Insulin resistance using HOMA-IR [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Biochemical parameters related to insulin resistance (adipocytokines, free fatty acids, 25-hydroxyvitamin D) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Traditional and non-traditional cardiovascular risk factors (lipids, apolipoproteins, fibrinogen, PAI-1, CRP) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Reproductive parameters (androgens, hirsutism) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	December 2008
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 fenofibrate 200mg/daily for 6 months	Drug: Fenofibrate fenofibrate 200 mg daily for 6-months
Placebo Comparator: 2 Placebo match for 6 months	Other: Placebo Placebo match for 6 months

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884819

Contacts

Contact: Tisha Joy, MD FRCPC	519-646-6296	tisha.joy@sjhc.london.on.ca
Contact: Lynda Bere, RN	519-646-6000 ext 65996

Locations

Canada, Ontario
St. Joseph's Health Care	Recruiting
London, Ontario, Canada, N6A 4L6
Contact: Tisha Joy, MD FRCPC 519-646-6296 tisha.joy@sjhc.london.on.ca
Principal Investigator: Tisha Joy, MD FRCPC

Sponsors and Collaborators

Lawson Health Research Institute

Investigators

Principal Investigator:

Tisha Joy, MD FRCPC

St. Joseph's Health Care, Department of Medicine

More Information

Publications:

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.

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.

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.

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.

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.

Responsible Party:	Tisha Joy, St. Joseph's Hospital/ Lawson Health Research Institute
ClinicalTrials.gov Identifier:	NCT00884819 History of Changes
Other Study ID Numbers:	R-08-573, 15581
Study First Received:	April 20, 2009
Last Updated:	January 4, 2011
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:

polycystic ovary syndrome
hepatic adiposity
diabetes
hormones
cardiovascular disease

Additional relevant MeSH terms:

Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders

Endocrine System Diseases
Fenofibrate
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012