About this trial
This randomized controlled clinical trial aims to evaluate the effect of orlistat on the metabolic and hormonal features of women with polycystic ovary syndrome (PCOS). Eligible women diagnosed with PCOS according to the Rotterdam criteria will be randomly assigned to receive either orlistat plus standard lifestyle advice or placebo plus standard lifestyle advice for three months. The study will assess the effect of orlistat on hormonal parameters, glucose metabolism, lipid profile, liver function, anthropometric measures, non-alcoholic fatty liver disease, and quality of life to determine its effectiveness as an adjunctive treatment for women with PCOS.
Eligibility criteria
Qualifiers
Females aged 18-45 years.
Oligomenorrhea or amenorrhea.
Clinical or biochemical hyperandrogenism.
Polycystic ovaries on ultrasonography.
Disqualifiers
Current or recent use of oral contraceptives, ovulation induction medications, anti-obesity medications, cholesterol-lowering medications, or other therapies/supplements known to affect insulin physiology or androgen metabolism (e.g., inositols, curcumin, lipoic acid, cinnamon, gymnemic, or other botanical extracts).
Women undergoing in vitro fertilization (IVF) treatment.
Known congenital adrenal hyperplasia, thyroid disorders, hyperprolactinemia, or diabetes mellitus.
Presence of severe renal or liver disease.
Trial design
Treatments tested in this trial
- Orlistat
- Placebo
- Standard Lifestyle Advice
Treatment groups
Locations
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