Effect of Orlistat on Metabolic and Hormonal Features in Women With Polycystic Ovary Syndrome (PCOS): a Randomized Controlled Clinical Trial | NCT07747909

NCT07747909

Overview

NCT ID: NCT07747909
Lead Sponsor: Khyber Medical University PeshawarOTHER
Official Title: Effect of Orlistat on Metabolic and Hormonal Features in Women With Polycystic Ovary Syndrome (PCOS): a Randomized Controlled Clinical Trial
Brief 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.
Conditions: Polycystic Ovary Syndrome

Status and Timeline

Status: Recruiting
Last Update Posted: Aug 5, 2026Actual
Start Date: Jan 1, 2026Actual
Primary Completion Date: Aug 10, 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Females aged 18-45 years.

Diagnosis of polycystic ovary syndrome (PCOS) according to the Rotterdam Criteria (presence of any two of the following):

Oligomenorrhea or amenorrhea.

Clinical or biochemical hyperandrogenism.

Polycystic ovaries on ultrasonography.

Body mass index (BMI) between 18.5 and 35 kg/m² (Asian criteria).

Exclusion Criteria:

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.

Menopausal, pregnant, or breastfeeding women.

Anti-Müllerian Hormone (AMH) < 0.7 ng/mL.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 120Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking

Contacts and Locations

Central Contacts: Prof Dr Ruqqiya Sultana, MBBSContact
ruqqia_sultana@yahoo.com

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