Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07747909
NA

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

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-01-01

Completion Date

2026-09-15

Last Updated

2026-08-05

Healthy Volunteers

No

Interventions

DRUG

Orlistat

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.

DRUG

Placebo

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).

BEHAVIORAL

Standard 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