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


N/A
18 Years
45 Years
Open (Enrolling)
Female
Polycystic Ovary Syndrome

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Hepatic adiposity as assessed using MRI

Outcome Time Frame:

6-months

Safety Issue:

No

Principal Investigator

Tisha Joy, MD FRCPC

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Joseph's Health Care, Department of Medicine

Authority:

Canada: Ethics Review Committee

Study ID:

R-08-573

NCT ID:

NCT00884819

Start Date:

December 2008

Completion Date:

October 2011

Related Keywords:

  • Polycystic Ovary Syndrome
  • polycystic ovary syndrome
  • hepatic adiposity
  • diabetes
  • hormones
  • cardiovascular disease
  • Polycystic Ovary Syndrome

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