An RCT of Metformin Vs Orlistat in Obese Anovulatory Women

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
• Collaborator: Hoffmann-La Roche
• Treatments: Metformin; Orlistat

Criteria

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