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

Primary Purpose

Polycystic Ovary Syndrome

Status

Terminated

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Fenofibrate

Placebo

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring polycystic ovary syndrome, hepatic adiposity, diabetes, hormones, cardiovascular disease

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

St. Joseph's Health Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

fenofibrate 200mg/daily for 6 months

Placebo match for 6 months

Outcomes

Primary Outcome Measures

Hepatic adiposity as assessed using MRI

Secondary Outcome Measures

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

Insulin resistance using HOMA-IR

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

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

Reproductive parameters (androgens, hirsutism)

Full Information

NCT ID

NCT00884819

First Posted

April 20, 2009

Last Updated

April 1, 2015

Sponsor

Lawson Health Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT00884819

Brief Title

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

Official Title

Effects of Fenofibrate on Metabolic and Reproductive Parameters in Polycystic Ovary Syndrome. A Randomized, Double-Blind, Placebo-Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Terminated

Why Stopped

Poor recruitment

Study Start Date

December 2008 (undefined)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Lawson Health Research Institute

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polycystic Ovary Syndrome

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

fenofibrate 200mg/daily for 6 months

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo match for 6 months

Intervention Type

Drug

Intervention Name(s)

Fenofibrate

Intervention Description

fenofibrate 200 mg daily for 6-months

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo match for 6 months

Primary Outcome Measure Information:

Title

Hepatic adiposity as assessed using MRI

Time Frame

6-months

Secondary Outcome Measure Information:

Title

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

Time Frame

6-months

Title

Insulin resistance using HOMA-IR

Time Frame

6 months

Title

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

Time Frame

6 months

Title

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

Time Frame

6 months

Title

Reproductive parameters (androgens, hirsutism)

Time Frame

6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tisha Joy, MD FRCPC

Organizational Affiliation

St. Joseph's Health Care, Department of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Joseph's Health Care

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4L6

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

12576508

Citation

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.

Results Reference

background

PubMed Identifier

15124979

Citation

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.

Results Reference

background

PubMed Identifier

12163016

Citation

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.

Results Reference

background

PubMed Identifier

11029601

Citation

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.

Results Reference

background

PubMed Identifier

10672386

Citation

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.

Results Reference

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

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