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

NCT00884819 | Terminated

• 2 other identifiers: R-08-57315581
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Hepatic adiposity as assessed using MRI

  6-months

Secondary Outcomes (5)

• Body composition using bioelectrical impedance analysis (BIA), anthropometry (skin-fold thickness measurement), and MRI

  6-months

• Insulin resistance using HOMA-IR

  6 months

• Biochemical parameters related to insulin resistance (adipocytokines, free fatty acids, 25-hydroxyvitamin D)

  6 months

• Traditional and non-traditional cardiovascular risk factors (lipids, apolipoproteins, fibrinogen, PAI-1, CRP)

  6 months

• Reproductive parameters (androgens, hirsutism)

  6 months

Study Arms (2)

1

EXPERIMENTAL

fenofibrate 200mg/daily for 6 months

Drug: Fenofibrate

2

PLACEBO COMPARATOR

Placebo match for 6 months

Other: Placebo

Interventions

Fenofibrate DRUG

fenofibrate 200 mg daily for 6-months

1

Placebo OTHER

Placebo match for 6 months

2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

St. Joseph's Health Care

London, Ontario, N6A 4L6, Canada

Location

Related Publications (5)

• 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. doi: 10.1194/jlr.M200327-JLR200. Epub 2002 Nov 4.

  PMID: 12576508 BACKGROUND

• 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. doi: 10.5414/cpp42212.

  PMID: 15124979 BACKGROUND

• 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. doi: 10.1016/s0006-291x(02)00822-7.

  PMID: 12163016 BACKGROUND

• Idzior-Walus B, Sieradzki J, Rostworowski W, Zdzienicka A, Kawalec E, Wojcik 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. doi: 10.1046/j.1365-2362.2000.00734.x.

  PMID: 11029601 BACKGROUND

• 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.

  PMID: 10672386 BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Diabetes Mellitus; Cardiovascular Diseases

Interventions

Fenofibrate

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones

Study Officials

• Tisha Joy, MD FRCPC

  St. Joseph's Health Care, Department of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Division of Endocrinology

Study Record Dates

• First Submitted: April 20, 2009
• First Posted: April 21, 2009
• Study Start: December 1, 2008
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: April 3, 2015

Record last verified: 2015-04

Locations

CA (1)