Ovarian Cysts Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Pakistan
Ayub Teaching Hospital
RECRUITING
Abbottābād
Contact Information
Primary
Prof Dr Ruqqiya Sultana, MBBS
ruqqia_sultana@yahoo.com
+92 314 5014992
Backup
Dr Noman Arif, PhD
nomanarif@kmu.edu.pk
+92 345 3059391
Time Frame
Start Date: 2026-01-01
Estimated Completion Date: 2026-09-15
Participants
Target number of participants: 120
Treatments
Experimental: Orlistat + Standard Lifestyle Advice
Participants will receive oral Orlistat capsules twice daily between lunch and dinner for 3 months in addition to standard lifestyle advice, including a healthy diet, regular physical activity, walking or cycling for at least 30 minutes daily, and other lifestyle modifications.
Placebo_comparator: Placebo + Standard Lifestyle Advice
Participants will receive matching placebo capsules twice daily for 3 months together with the same standard lifestyle advice, including a healthy diet, regular physical activity, walking or cycling for at least 30 minutes daily, and other lifestyle modifications
Sponsors
Leads: Khyber Medical University Peshawar

This content was sourced from clinicaltrials.gov