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
Recruitment status was Recruiting
Sponsor:
Lawson Health Research Institute
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
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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 May 19, 2013