Clinical trial · Interventional
Effects of Fenofibrate on Metabolic and Reproductive Parameters in Polycystic Ovary Syndrome
Effects of Fenofibrate on Metabolic and Reproductive Parameters in Polycystic Ovary Syndrome. A Randomized, Double-Blind, Placebo-Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor recruitment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fenofibrate | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- fenofibrate 200mg/daily for 6 months
- interventionNames
- Drug: Fenofibrate
- type
- PLACEBO_COMPARATOR
- label
- 2
- description
- Placebo match for 6 months
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Hepatic adiposity as assessed using MRI
- timeFrame
- 6-months
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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.
References
Publications (5)
- BACKGROUNDToda 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. PMID 12576508
- BACKGROUNDWysocki 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. PMID 15124979
- BACKGROUNDLee 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. PMID 12163016
- BACKGROUNDIdzior-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. PMID 11029601
- BACKGROUNDYong 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. PMID 10672386