A Randomised Controlled Clinical Trial of Metformin Versus Orlistat for the Management of Obese Anovulatory Women
Abstract
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: Anovulation, Obesity.
Primary outcome: Outcome measures:; 1- The occurrence of ovulation as measured by day-21 serum progesterone ( equal to or more than 30mmol/L).; 2- Number of patients who have lost at least 5% of body weight at the end of the study.; 3- Improvement/deterioration of clinical symptoms: hyper androgenic features, obesity and menstrual disturbances; 4- Change in the ovarian Doppler indices..
Enrollment: 36 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 36 participants or records.
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