Status:
COMPLETED
An RCT of Metformin Vs Orlistat in Obese Anovulatory Women
Lead Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Anovulation
Obesity
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief 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. Pa...
Detailed Description
We aim to recruit 40 patients suffering from anovulatory obesity with a BMI of 30 or more. Patients will be included from all ethnic groups. Patients will have a baseline history, clinical examinatio...
Eligibility 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:
- BMI of less than 30
- Patients not requesting treatment for their symptoms
- Patients with contraindications for any of the medications: renal or hepatic impairment, malabsorption syndrome, cholestasis
- Diabetic patients
- Pregnancy
- Breast feeding
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00292799
Start Date
February 1 2006
End Date
February 1 2008
Last Update
September 27 2021
Active Locations (1)
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1
Sheffield Teaching Hospitals NHS Trust, Jessop Wing
Sheffield, United Kingdom, S10 2SF