RecruitingNot ApplicableNCT07747909

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

Sponsor

Khyber Medical University Peshawar

Enrollment

120 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Polycystic Ovary Syndrome

Summary

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

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Orlistat, a drug called Placebo, and others for people with polycystic ovary syndrome. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years to 45 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOrlistat

Oral 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.

DRUGPlacebo

Matching 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).

BEHAVIORALStandard Lifestyle Advice

Participants 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.

Locations(1)

Ayub Teaching Hospital

Abbottābād, Khyber Pakhtunkhwa, Pakistan

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NCT07747909

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