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An RCT of Metformin Vs Orlistat in Obese Anovulatory Women

This study has been completed.
Sponsor:
Information provided by:
Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00292799
First received: February 15, 2006
Last updated: July 15, 2008
Last verified: July 2008
  Purpose

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


Condition Intervention
Anovulation
Obesity
Drug: Orlistat Vs Metformin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised Controlled Clinical Trial of Metformin Versus Orlistat for the Management of Obese Anovulatory Women.

Resource links provided by NLM:


Further study details as provided by Sheffield Teaching Hospitals NHS Foundation Trust:

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.

Enrollment: 36
Study Start Date: February 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292799

Locations
United Kingdom
Sheffield Teaching Hospitals NHS Trust, Jessop Wing
Sheffield, United Kingdom, S10 2SF
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Investigators
Study Chair: Professor William L Ledger, D.Phil,FRCOG Sheffield University
Study Director: Dr Mostafa Metwally Sheffield University
Study Chair: Professor TC Li Sheffield Teaching Hospitals
  More Information

No publications provided by Sheffield Teaching Hospitals NHS Foundation Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00292799     History of Changes
Other Study ID Numbers: STH14007
Study First Received: February 15, 2006
Last Updated: July 15, 2008
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:
Polycystic ovary syndrome
Obesity
metformin
orlistat

Additional relevant MeSH terms:
Anovulation
Obesity
Adnexal Diseases
Body Weight
Endocrine System Diseases
Genital Diseases, Female
Gonadal Disorders
Nutrition Disorders
Ovarian Diseases
Overnutrition
Overweight
Signs and Symptoms
Metformin
Orlistat
Anti-Obesity Agents
Central Nervous System Agents
Enzyme Inhibitors
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014