Orlistat for metabolic and hormonal features in women with PCOS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-arm, single-center study will enroll 120 women with PCOS to receive either orlistat plus standard lifestyle advice or placebo plus standard lifestyle advice for 12 weeks. Participants will be assessed at baseline, 1 month, 2 months, and at the end of the 3-month period for hormonal parameters, glucose and lipid metabolism, liver function, body measurements, non-alcoholic fatty liver disease markers, and quality of life. The primary outcome is improvement in at least one abnormal metabolic or hormonal feature. The trial is conducted at Ayub Teaching Hospital, Abbottabad, with adherence monitored via telephone follow-ups. The findings may indicate whether orlistat can serve as an adjunctive treatment to improve health outcomes in PCOS.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• Ayub Teaching Hospital
  Abbottābād, Khyber Pakhtunkhwa, Pakistan Recruiting

Study contacts

• Principal investigator: Prof Dr Ruqqiya Sultana, MBBS — Khyber Medical Univeristy Peshawar
• Study coordinator: Prof Dr Ruqqiya Sultana, MBBS
• Email: ruqqia_sultana@yahoo.com
• Phone: +92 314 5014992

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Precision acupuncture and lifestyle for PCOS

  This trial tests whether a precision acupuncture approach combined with a personalized lifestyle plan helps improve insulin resistance in people with PCOS compared with conventional acupuncture and standard lifestyle changes.

  Recruiting Peking University Third Hospital · Beijing, Beijing Municipality and 1 other locations · NCT07809503

• Physical activity program for women with PCOS and fatty pancreas plus subclinical hypothyroidism

  A program of exercise is being tested to see if it helps women with PCOS who also have fatty pancreas and subclinical hypothyroidism, compared to usual care.

  Recruiting Cairo University · Giza · NCT07591246

• Glucose monitoring in women with polycystic ovary syndrome

  This project will use continuous glucose monitors to see if daily glucose patterns differ among adult women with different PCOS phenotypes.

  Recruiting Centre Hospitalier Universitaire, Amiens · Salouël · NCT07483723

• Adding regular exercise to a low‑calorie diet and metformin for women with PCOS and asthma

  This study will test whether adding regular treadmill walking to a low‑calorie diet and daily metformin helps women who have both PCOS and asthma.

  Recruiting Cairo University · Giza, Dokki · NCT07446985

• Identifying insulin-resistant PCOS with LMNA-related lipodystrophy in young women

  We’re testing whether women with a genetic insulin resistance and lipodystrophy differ from women with PCOS by age and BMI matching.

  Recruiting Assistance Publique - Hôpitaux de Paris · Paris · NCT07412028

• Combining Dlbs 3233 with clomiphene citrate for PCOS

  This will test whether adding Dlbs 3233 to clomiphene citrate helps women with PCOS improve insulin resistance (HOMA-IR), follicle maturation, and menstrual cycle regularity.

  Recruiting Early Phase 1 Inlacinpenelitian · Yogyakarta, DIY · NCT07403201

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.