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Study identifier: NCT07747909 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: Recruiting

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

Condition: Polycystic Ovary Syndrome  ·  Sponsor: Khyber Medical University Peshawar

PhaseNA
Planned participants120
Who can joinFemale, 18 Years to 45 Years
Healthy volunteersNoCheck eligibility criteria ↓
WhereAbbottābād, Khyber Pakhtunkhwa, Pakistan

Interested? Contact the study team ↓

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Prof Dr Ruqqiya Sultana, MBBS  ·  +92 314 5014992  ·  ruqqia_sultana@yahoo.com

Dr Noman Arif, PhD  ·  +92 345 3059391  ·  nomanarif@kmu.edu.pk

There is no obligation to join — the study team can answer your questions about taking part.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (1)

Ayub Teaching HospitalAbbottābād, Khyber Pakhtunkhwa, PakistanRecruiting

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