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An RCT of Metformin Vs Orlistat in Obese Anovulatory Women

Primary Purpose

Anovulation, Obesity

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Orlistat Vs Metformin
Sponsored by
Sheffield Teaching Hospitals NHS Foundation Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anovulation focused on measuring Polycystic ovary syndrome, Obesity, metformin, orlistat

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Sheffield Teaching Hospitals NHS Trust, Jessop Wing

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 15, 2006
Last Updated
September 21, 2021
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00292799
Brief Title
An RCT of Metformin Vs Orlistat in Obese Anovulatory Women
Official Title
A Randomised Controlled Clinical Trial of Metformin Versus Orlistat for the Management of Obese Anovulatory Women.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
Hoffmann-La Roche

4. Oversight

5. Study Description

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. 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
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 examination, hormonal profile (FSH/LH, fasting Insulin/glucose ratio, androgen profile, day 21 serum progesterone, serum leptin and ghrelin levels) ultrasound examination (ovarian volume and antral follicle count), including Doppler blood flow study (ovarian stromal velocity, PI, RI, SD ratio and power Doppler) Participants will then be randomised to receive either metformin or orlistat. Patients receiving orlistat will receive the standard dose of the drug as recommended in the BNF. Metformin will be given in an incremental dose starting at 1000mg per day and increased at 4 weekly intervals to 2000mg/d, depending on the occurrence of any gastrointestinal intolerance. The endocrinological and ultrasound investigations will be repeated at 4 weekly intervals. Both groups will be given a standard exercise and diet program in conjunction with medical treatment. The clinical endpoint will be the achievement of conception, a Body Mass Index of less than 30, or completion of a 3-month course of treatment. Study design: A randomised controlled open label clinical trial. Participants be randomised using a computer generated randomisation program available at the pharmacy of the Jessop Wing, into either one of two arms: metformin or orlistat. The randomisation will be stratified in order to achieve a homogenous distribution of PCOS and non-PCOS patients in both arms of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anovulation, Obesity
Keywords
Polycystic ovary syndrome, Obesity, metformin, orlistat

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Orlistat Vs Metformin
Primary Outcome Measure Information:
Title
Outcome measures:
Title
1- The occurrence of ovulation as measured by day-21 serum progesterone ( equal to or more than 30mmol/L).
Title
2- Number of patients who have lost at least 5% of body weight at the end of the study.
Title
3- Improvement/deterioration of clinical symptoms: hyper androgenic features, obesity and menstrual disturbances
Title
4- Change in the ovarian Doppler indices.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Professor William L Ledger, D.Phil,FRCOG
Organizational Affiliation
Sheffield University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dr Mostafa Metwally
Organizational Affiliation
Sheffield University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Professor TC Li
Organizational Affiliation
Sheffield Teaching Hospitals NHS Foundation Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Sheffield Teaching Hospitals NHS Trust, Jessop Wing
City
Sheffield
ZIP/Postal Code
S10 2SF
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19095663
Citation
Metwally 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.
Results Reference
derived

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An RCT of Metformin Vs Orlistat in Obese Anovulatory Women

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