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NCT07747909Recruiting

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

Source: ClinicalTrials.gov · Last updated 5 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
120 (estimated)
First submitted
31 Jul 2026
Start date
1 Jan 2026
Primary completion date
10 Aug 2026
Lead sponsor
Khyber Medical University Peshawar
NCT number
NCT07747909

What you commit to

  • Study type: Interventional
  • Planned participants: 120
  • From 1 Jan 2026 to the primary completion date, 10 Aug 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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).

Other illness

  • Known congenital adrenal hyperplasia, thyroid disorders, hyperprolactinemia, or diabetes mellitus.
  • Presence of severe renal or liver disease.

Other

  • Women undergoing in vitro fertilization (IVF) treatment.
  • Menopausal, pregnant, or breastfeeding women.
  • Anti-Müllerian Hormone (AMH) \< 0.7 ng/mL.

Who the study is looking for

  • 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).

Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ayub Teaching Hospital
Coordinator of this site? Confirm its status
AbbottābādPakistanRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.