An RCT of Metformin Vs Orlistat in Obese Anovulatory Women

NCT00292799 | Completed

• 1 other identifier: STH14007
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Anovulation; Obesity

Keywords

Polycystic ovary syndrome; Obesity; metformin; orlistat

Outcome Measures

Primary Outcomes (5)

• 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.

Interventions

Orlistat Vs Metformin DRUG

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• Hoffmann-La Roche: collaborator

Study Sites (1)

Sheffield Teaching Hospitals NHS Trust, Jessop Wing

Sheffield, S10 2SF, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 19095663 DERIVED

MeSH Terms

Conditions

Anovulation; Obesity; Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Ovarian Cysts; Cysts; Neoplasms

Study Officials

• Professor William L Ledger, D.Phil,FRCOG

  Sheffield University

  STUDY CHAIR

• Dr Mostafa Metwally

  Sheffield University

  STUDY DIRECTOR

• Professor TC Li

  Sheffield Teaching Hospitals NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2006
• First Posted: February 16, 2006
• Study Start: February 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: September 27, 2021

Record last verified: 2021-09

Locations

GB (1)