Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00292799
Status:
COMPLETED
Last Update Posted:
2021-09-27
First Post:
2006-02-15
Brief Title:
An RCT of Metformin Vs Orlistat in Obese Anovulatory Women
Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Organization:
Sheffield Teaching Hospitals NHS Foundation Trust
Study Overview
Official Title:
A Randomised Controlled Clinical Trial of Metformin Versus Orlistat for the Management of Obese Anovulatory Women
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 FSHLH fasting Insulinglucose 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 2000mgd 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
Patients will have a baseline history clinical examination hormonal profile FSHLH fasting Insulinglucose 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 2000mgd 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None