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

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ClinicalTrials.gov Identifier: NCT00884819
Recruitment Status : Terminated (Poor recruitment)
First Posted : April 21, 2009
Last Update Posted : April 3, 2015
Sponsor:
Information provided by (Responsible Party):

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
Polycystic Ovary Syndrome Drug: Fenofibrate Other: Placebo

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
Primary Completion Date : February 2015
Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Fenofibrate
U.S. FDA Resources

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00884819


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:
Responsible Party: Tisha Joy, Assistant Professor, Division of Endocrinology, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00884819     History of Changes
Other Study ID Numbers: R-08-573
15581 ( Other Identifier: UWO Ethics )
First Posted: April 21, 2009    Key Record Dates
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:
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
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
Lipid Regulating Agents