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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorKhyber Medical University Peshawar

About this trial

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 criteria

Qualifiers

Females aged 18-45 years.

Oligomenorrhea or amenorrhea.

Clinical or biochemical hyperandrogenism.

Polycystic ovaries on ultrasonography.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Orlistat
  • Placebo
  • Standard Lifestyle Advice

Treatment groups

120 Participants
are divided into 2 treatment groups

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Ayub Teaching HospitalRecruiting Abbottābād, Khyber PakhtunkhwaPakistanPakistan