Tests orlistat with lifestyle advice in women with polycystic ovary syndrome
Compares orlistat with placebo, both alongside lifestyle advice, in women with PCOS.
Plain-language title generated from the registry record
Registry title: Effect of Orlistat on Metabolic and Hormonal Features in Women With Polycystic Ovary Syndrome (PCOS): a Randomized Controlled Clinical Trial
Key facts
- Where
- Abbottābād, PakistanSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women aged 18-45 years with polycystic ovary syndrome (PCOS). They take orlistat or a placebo for three months, together with lifestyle advice.
- Age
- 18 to 45 years
- Sex
- Women only
- Disease stage
- PCOS diagnosed by the Rotterdam criteria: any two of irregular or absent periods, high male hormones (clinical or in blood tests), or polycystic ovaries on ultrasound.
- Earlier treatment
- No current or recent use of oral contraceptives, ovulation induction medicines, anti-obesity medicines, cholesterol-lowering medicines, or supplements that affect insulin or androgen levels.
- Biomarker or test result
- Body mass index (BMI) between 18.5 and 35 kg/m². Anti-Müllerian Hormone (AMH) must not be below 0.7 ng/mL.
Main reasons for not taking part
- Women having in vitro fertilization (IVF) treatment
- Congenital adrenal hyperplasia, thyroid disorders, hyperprolactinemia, or diabetes mellitus
- Severe kidney or liver disease
- Menopausal, pregnant, or breastfeeding women
- Anti-Müllerian Hormone (AMH) below 0.7 ng/mL
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 45 years old?
Source: NCT07747909, who can take part
Where in Pakistan
- Ayub Teaching HospitalAbbottābād, PakistanContact: Dr. Ruqqiya Sultana, MBBSTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Khyber Medical University Peshawar
- Trial code
- NCT07747909
- Record updated
- 5 August 2026
- Original description
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.Read full original descriptionShow less
Effect of Orlistat on Metabolic and Hormonal Features in Women With Polycystic Ovary Syndrome (PCOS): a Randomized Controlled Clinical 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.
Inclusion: 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).
Exclusion: 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); Known congenital adrenal hyperplasia, thyroid disorders, hyperprolactinemia, or diabetes mellitus; Presence of severe renal or liver disease; Women undergoing in vitro fertilization (IVF) treatment; Menopausal, pregnant, or breastfeeding women; Anti-Müllerian Hormone (AMH) < 0.7 ng/mL.