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.
Females aged 18-45 years.
Oligomenorrhea or amenorrhea.
Clinical or biochemical hyperandrogenism.
Polycystic ovaries on ultrasonography.
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.
Parallel
Orlistat
DrugOral Orlistat capsules administered twice daily between lunch and dinner for 3 months as an adjunct to the recommended care plan for women with polycystic ovary syndrome (PCOS). Participants will also receive standard lifestyle advice, including a healthy diet, regular physical activity, walking, and cycling.
Placebo
DrugMatching placebo capsules administered twice daily for 3 months in addition to standard lifestyle advice, including a healthy diet, regular physical activity, walking, and cycling, for women with polycystic ovary syndrome (PCOS).
Standard Lifestyle Advice
BehavioralParticipants will receive standardized lifestyle advice, including maintaining a healthy diet, engaging in regular physical activity, and performing at least 30 minutes of walking or cycling daily throughout the 3-month study period.
Polycystic Ovary Syndrome (PCOS) Features
Improvement in at least one baseline abnormality according to the Rotterdam Criteria, including ovulatory dysfunction, hyperandrogenism, or polycystic ovarian morphology on ultrasonography.
Luteinizing Hormone/Follicle Stimulating Hormone (LH/FSH) Ratio
Change in serum LH/FSH ratio measured by laboratory assay. Higher values indicate greater hormonal imbalance.
Anti-Müllerian Hormone (AMH)
Change in serum Anti-Müllerian Hormone concentration (ng/mL) measured by laboratory assay.
Follicle Stimulating Hormone (FSH)
Change in serum FSH concentration (IU/L) measured by laboratory assay
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