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

• ClinicalTrials.gov Identifier: NCT00884819
• Recruitment Status: Terminated
• First Posted: April 21, 2009
• Last Update Posted: April 3, 2015
• Sponsor: Lawson Health Research Institute
• Information provided by (Responsible Party): Tisha Joy, Lawson Health Research Institute

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Polycystic Ovary Syndrome	Drug: Fenofibrate; Other: Placebo	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 4 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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
• Study Start Date: December 2008
• Actual Primary Completion Date: February 2015
• Actual Study Completion Date: February 2015

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Hepatic adiposity as assessed using MRI [ Time Frame: 6-months ]

Secondary Outcome Measures :

1. Body composition using bioelectrical impedance analysis (BIA), anthropometry (skin-fold thickness measurement), and MRI [ Time Frame: 6-months ]
2. Insulin resistance using HOMA-IR [ Time Frame: 6 months ]
3. Biochemical parameters related to insulin resistance (adipocytokines, free fatty acids, 25-hydroxyvitamin D) [ Time Frame: 6 months ]
4. Traditional and non-traditional cardiovascular risk factors (lipids, apolipoproteins, fibrinogen, PAI-1, CRP) [ Time Frame: 6 months ]
5. Reproductive parameters (androgens, hirsutism) [ Time Frame: 6 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes 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

Locations

Canada, Ontario

St. Joseph's Health Care

London, Ontario, Canada, N6A 4L6

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 Singap. 1999 Nov;28(6):778-82.

• Responsible Party: Tisha Joy, Assistant Professor, Division of Endocrinology, Lawson Health Research Institute
• ClinicalTrials.gov Identifier: NCT00884819
• Other Study ID Numbers: R-08-573; 15581 ( Other Identifier: UWO Ethics )
• First Posted: April 21, 2009
• Last Update Posted: April 3, 2015
• Last Verified: April 2015

Keywords provided by Tisha Joy, Lawson Health Research Institute:

polycystic ovary syndrome; hepatic adiposity; diabetes; hormones; cardiovascular disease

Additional relevant MeSH terms:

Polycystic Ovary Syndrome; Syndrome; Disease; Pathologic Processes; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine System Diseases; Fenofibrate; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents