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Polycystic Ovary SyndromeNCT00884819

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

A study testing Fenofibrate in people with Polycystic Ovary Syndrome, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Polycystic Ovary Syndrome
What is being tested?
Fenofibrate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
4 participants
Where
1 siteCanada
Study dates
Dec 2008to Feb 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • St. Joseph's Health Care

    London, Ontario, N6A 4L6

Other trials in Canada

About this study

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

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.

Being tested
Fenofibrate, Placebo
Keywords
polycystic ovary syndrome, hepatic adiposity, diabetes, hormones, cardiovascular disease
Medical subject headings
Polycystic Ovary Syndrome, Diabetes Mellitus, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FenofibrateDrug

    fenofibrate 200 mg daily for 6-months

  • PlaceboOther

    Placebo match for 6 months

Study groups in NCT00884819
Study groupRoleWhat they receive
1Experimentalfenofibrate 200mg/daily for 6 months
Receives: Drug: Fenofibrate
2Placebo comparatorPlacebo match for 6 months
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hepatic adiposity as assessed using MRI

    Measured: 6-months

Secondary outcomes (5)

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

    Measured: 6-months

  2. Insulin resistance using HOMA-IR

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

  5. Reproductive parameters (androgens, hirsutism)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2009 (estimated)
  2. Study startDec 2008
  3. Primary completionFeb 2015
  4. Study completionFeb 2015

Why it stopped: Poor recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00884819
Sponsor's protocol ID
R-08-573
Other IDs
15581
Status last verified
Apr 2015
First submitted
20 Apr 2009
Last updated
3 Apr 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 12576508

  • 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.

    PubMed 15124979

  • 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.

    PubMed 12163016

  • 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.

    PubMed 11029601

  • 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.

    PubMed 10672386

Questions about this trial

What is this clinical trial studying?

A study testing Fenofibrate in people with Polycystic Ovary Syndrome, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hepatic adiposity as assessed using MRI (time frame: 6-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00884819, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2015.

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