Effect of Orlistat on Metabolic and Hormonal Features in Women With Polycystic Ovary Syndrome (PCOS): a Randomized Controlled Clinical Trial
1 other identifier
interventional
120
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2026
CompletedFirst Submitted
Initial submission to the registry
July 31, 2026
CompletedFirst Posted
Study publicly available on registry
August 5, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 10, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 15, 2026
August 5, 2026
July 1, 2026
7 months
July 31, 2026
July 31, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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.
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.
Baseline and 3 months
Anti-Müllerian Hormone (AMH)
Change in serum Anti-Müllerian Hormone concentration (ng/mL) measured by laboratory assay.
Baseline and 3 months
Follicle Stimulating Hormone (FSH)
Change in serum FSH concentration (IU/L) measured by laboratory assay
Baseline and 3 months
Luteinizing Hormone (LH)
Change in serum LH concentration (IU/L) measured by laboratory assay.
Baseline and 3 months
Free Testosterone
Change in serum free testosterone concentration measured by laboratory assay.
Baseline and 3 months
Fasting Blood Glucose
Change in fasting blood glucose concentration (mg/dL) measured by laboratory assay.
Baseline and 3 months
Study Arms (2)
Orlistat + Standard Lifestyle Advice
EXPERIMENTALParticipants 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 + Standard Lifestyle Advice
PLACEBO COMPARATORParticipants 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
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ayub Teaching Hospital
Abbottābād, Khyber Pakhtunkhwa, Pakistan
Related Publications (5)
March WA, Moore VM, Willson KJ, Phillips DI, Norman RJ, Davies MJ. The prevalence of polycystic ovary syndrome in a community sample assessed under contrasting diagnostic criteria. Hum Reprod. 2010 Feb;25(2):544-51. doi: 10.1093/humrep/dep399. Epub 2009 Nov 12.
PMID: 19910321BACKGROUNDGrundy SM, Cleeman JI, Daniels SR, Donato KA, Eckel RH, Franklin BA, Gordon DJ, Krauss RM, Savage PJ, Smith SC Jr, Spertus JA, Costa F; American Heart Association; National Heart, Lung, and Blood Institute. Diagnosis and management of the metabolic syndrome: an American Heart Association/National Heart, Lung, and Blood Institute Scientific Statement. Circulation. 2005 Oct 25;112(17):2735-52. doi: 10.1161/CIRCULATIONAHA.105.169404. Epub 2005 Sep 12. No abstract available.
PMID: 16157765BACKGROUNDAlberti KG, Eckel RH, Grundy SM, Zimmet PZ, Cleeman JI, Donato KA, Fruchart JC, James WP, Loria CM, Smith SC Jr; International Diabetes Federation Task Force on Epidemiology and Prevention; Hational Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; International Association for the Study of Obesity. Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation. 2009 Oct 20;120(16):1640-5. doi: 10.1161/CIRCULATIONAHA.109.192644. Epub 2009 Oct 5.
PMID: 19805654BACKGROUNDTeede HJ, Misso ML, Deeks AA, Moran LJ, Stuckey BG, Wong JL, Norman RJ, Costello MF; Guideline Development Groups. Assessment and management of polycystic ovary syndrome: summary of an evidence-based guideline. Med J Aust. 2011 Sep 19;195(6):S65-112. doi: 10.5694/mja11.10915. No abstract available.
PMID: 21929505BACKGROUNDCroze ML, Soulage CO. Potential role and therapeutic interests of myo-inositol in metabolic diseases. Biochimie. 2013 Oct;95(10):1811-27. doi: 10.1016/j.biochi.2013.05.011. Epub 2013 Jun 10.
PMID: 23764390BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Prof Dr Ruqqiya Sultana, MBBS
Khyber Medical Univeristy Peshawar
- PRINCIPAL INVESTIGATOR
Dr Noman Arif, PhD
Khyber Medical Univeristy Peshawar
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Participants will be blinded to treatment allocation. Participants in the intervention and control groups will receive identical-appearing capsules (Orlistat or placebo). Care providers, investigators, and outcome assessors will not be blinded to group assignment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2026
First Posted
August 5, 2026
Study Start
January 1, 2026
Primary Completion (Estimated)
August 10, 2026
Study Completion (Estimated)
September 15, 2026
Last Updated
August 5, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- 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.
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.