An interventional study of Orlistat and Placebo in Polycystic Ovary Syndrome, sponsored by Khyber Medical University Peshawar. Recruiting at 1 site in Pakistan. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by Khyber Medical University Peshawar · Not applicable, Interventional, and Treatment
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.
Polycystic ovary syndrome (PCOS) is one of the most common endocrine and metabolic disorders affecting women of reproductive age and is frequently associated with obesity, insulin resistance, dyslipidemia, and hormonal imbalance. Lifestyle modification remains the cornerstone of management; however, additional therapeutic options are needed to improve metabolic and reproductive outcomes. Orlistat, a gastrointestinal lipase inhibitor, promotes weight reduction by decreasing dietary fat absorption and has demonstrated potential benefits in improving insulin resistance and lipid metabolism.
This study is a single-center, randomized controlled clinical trial to be conducted at Ayub Teaching Hospital, Abbottabad. A total of 120 women aged 18-45 years with PCOS diagnosed according to the Rotterdam criteria will be enrolled and randomly allocated in a 1:1 ratio to either the intervention group or the control group. Participants in the intervention group will receive orlistat capsules twice daily in addition to standard lifestyle advice, while participants in the control group will receive placebo together with the same lifestyle recommendations, including a healthy diet and regular physical activity. The intervention period will last three months.
Participants will undergo baseline assessment, telephone follow-up visits at one and two months to monitor treatment adherence, and a final in-person assessment after three months. The primary outcome is improvement in at least one abnormality defined by the Rotterdam diagnostic criteria. Secondary outcomes include changes in sex hormone profile (LH, FSH, LH/FSH ratio, AMH, and free testosterone), fasting glucose and insulin parameters, HbA1c, lipid profile, liver function tests, lipid accumulation product, hepatic steatosis index, ultrasound grading of non-alcoholic fatty liver disease, anthropometric measures, and PCOS-related quality of life. The findings of this study will provide evidence regarding the effectiveness of orlistat as an adjunct to lifestyle modification for improving the metabolic and hormonal manifestations of PCOS in women.
956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.
This study's planned enrollment of 120 is above the median of 70 across 697 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Khyber Medical University Peshawar is the lead sponsor of 54 studies on the registry; 13 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Orlistat · Behavioral: 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
Drug: Placebo · Behavioral: Standard Lifestyle Advice
Oral Orlistat capsules administered twice daily between lunch and dinner for 3 months as an adjunct to the recommended care plan for women with polycystic ovary syndrome (PCOS). Participants will also receive standard lifestyle advice, including a healthy diet, regular physical activity, walking, and cycling.
Also known as: Oral Orlistat capsules
Matching placebo capsules administered twice daily for 3 months in addition to standard lifestyle advice, including a healthy diet, regular physical activity, walking, and cycling, for women with polycystic ovary syndrome (PCOS).
Participants will receive standardized lifestyle advice, including maintaining a healthy diet, engaging in regular physical activity, and performing at least 30 minutes of walking or cycling daily throughout the 3-month study period.
Also known as: Lifestyle Modification
Polycystic Ovary Syndrome (PCOS) Features
Improvement in at least one baseline abnormality according to the Rotterdam Criteria, including ovulatory dysfunction, hyperandrogenism, or polycystic ovarian morphology on ultrasonography.
Time frame: Baseline and 3 months
Luteinizing Hormone/Follicle Stimulating Hormone (LH/FSH) Ratio
Change in serum LH/FSH ratio measured by laboratory assay. Higher values indicate greater hormonal imbalance.
Time frame: Baseline and 3 months
Anti-Müllerian Hormone (AMH)
Change in serum Anti-Müllerian Hormone concentration (ng/mL) measured by laboratory assay.
Time frame: Baseline and 3 months
Follicle Stimulating Hormone (FSH)
Change in serum FSH concentration (IU/L) measured by laboratory assay
Time frame: Baseline and 3 months
Luteinizing Hormone (LH)
Change in serum LH concentration (IU/L) measured by laboratory assay.
Time frame: Baseline and 3 months
Free Testosterone
Change in serum free testosterone concentration measured by laboratory assay.
Time frame: Baseline and 3 months
Fasting Blood Glucose
Change in fasting blood glucose concentration (mg/dL) measured by laboratory assay.
Time frame: Baseline and 3 months
Plan to share: Yes — De-identified individual participant data underlying the results reported in the publication, including demographic characteristics, baseline and outcome data, will be made available to qualified researchers upon reasonable request after publication of the primary study results.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data will become available beginning 6 months after publication of the primary study results and remain available for up to 5 years.
Access criteria: Access will be granted to qualified researchers whose proposed use of the data has been approved by the Principal Investigator and Institutional Review Board. Data will be provided after execution of an appropriate data-sharing agreement and only for scientifically sound research purposes.
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Studies of the drug tested here: Orlistat
Khyber Medical University Peshawar