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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Lawson Health Research Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00884819
First received: April 20, 2009
Last updated: January 4, 2011
Last verified: January 2011
  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:


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:
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 April 14, 2014