Evaluating Orlistat with Lifestyle Changes to Improve Metabolic and Hormonal Health in Women Aged 18-45 with Polycystic Ovary Syndrome

What this Trial Is About

Researchers are evaluating the effects of orlistat on the metabolic and hormonal features of women with polycystic ovary syndrome PCOS, a common endocrine and metabolic disorder affecting women of reproductive age. The study aims to determine whether orlistat, combined with lifestyle changes, can improve hormonal balance, glucose metabolism, lipid levels, liver function, body measurements, non-alcoholic fatty liver disease, and quality of life in women diagnosed with PCOS according to the Rotterdam criteria. In this randomized controlled trial, 120 women aged 18 to 45 with PCOS will be assigned to one of two groups. One group will receive oral orlistat capsules twice daily plus standard lifestyle advice including a healthy diet and at least 30 minutes of daily walking or cycling, while the other group will receive matching placebo capsules plus the same lifestyle advice. The intervention lasts for three months. Participants will have a baseline evaluation, followed by telephone follow-ups at one and two months to check treatment adherence, and a final in-person assessment after three months. Researchers will measure changes in PCOS features, hormonal levels such as LH, FSH, AMH, and testosterone, blood glucose and insulin markers, lipid profile, liver tests, ultrasound grading of fatty liver, body measurements, and quality of life related to PCOS. This study will provide data on orlistats role as an adjunctive treatment for PCOS.

Effect of Orlistat on Metabolic and Hormonal Features in Women With Polycystic Ovary Syndrome (PCOS): a Randomized Controlled Clinical Trial