Clinical trial · Interventional
An RCT of Metformin Vs Orlistat in Obese Anovulatory Women
A Randomised Controlled Clinical Trial of Metformin Versus Orlistat for the Management of Obese Anovulatory Women.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to investigate the role of the weight reduction agent, Orlistat compared to the Metformin for the management of women who are obese and do not ovulate or have difficulty conceiving. Patients will receive either one of these medications and will be monitored at regular intervals with hormone blood tests and ultrasound scans in order to study the effect of the medications on the reproductive functions. Patients will receive the medications for three months and the study will end if the patient becomes pregnant. The study also aims to investigate the dose of metformin that should be used as there is no consensus to date regarding the optimum dosage for this drug
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anovulation | — | UNRESOLVED | — |
| Obesity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Orlistat Vs Metformin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (5)
- measure
- Outcome measures:
- measure
- 1- The occurrence of ovulation as measured by day-21 serum progesterone ( equal to or more than 30mmol/L).
- measure
- 2- Number of patients who have lost at least 5% of body weight at the end of the study.
- measure
- 3- Improvement/deterioration of clinical symptoms: hyper androgenic features, obesity and menstrual disturbances
- measure
- 4- Change in the ovarian Doppler indices.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: 1\. In the childbearing period 2. Obese with a body mass index of 30 or more. 3. Are anovulatory as shown by day 21-serum progesterone. 4. Polycystic ovarian syndrome will be diagnosed according if at least two of the following three features are present, after exclusion of other aetiologies (Azziz, 2004): (i) Oligo- or anovulation, (ii) Clinical and/or biochemical hyperandrogenism (iii) Polycystic ovaries. Exclusion Criteria: 1. BMI of less than 30 2. Patients not requesting treatment for their symptoms 3. Patients with contraindications for any of the medications: renal or hepatic impairment, malabsorption syndrome, cholestasis 4. Diabetic patients 5. Pregnancy 6. Breast feeding
References
Publications (1)
- DERIVEDMetwally M, Amer S, Li TC, Ledger WL. An RCT of metformin versus orlistat for the management of obese anovulatory women. Hum Reprod. 2009 Apr;24(4):966-75. doi: 10.1093/humrep/den454. Epub 2008 Dec 18. PMID 19095663