A randomised controlled clinical trial of metformin versus orlistat for the management of obses anovulatory women - n/a
Phase 1
- Conditions
- Anovulatory Obese Women
- Registration Number
- EUCTR2005-002096-32-GB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 0
Inclusion Criteria
1. Obese women with abody mas index of 30 or more
2. Anovulatory as shown by a day 21-serum progesterone
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1. DIABETES
2.PATIENTS WITH ANY CONTRAINDICATIONS TOE THE USE OF METFROMIN OR ORLISTAT AS STATED IN THE NF
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: In obese anovulatory patients would the use of metformin or orlisata lead to the achievement of ovulation;Secondary Objective: 1. Is there a difference in reponse to metformin and/or orlistat in obese anovulatory patients with or wiyhout polycystic ovarian syndrome<br>2. If metformin proves ot have beneficial effect, then what is the optimal dose<br>3. What is the effect of metformin and orlistat on the ovarian vasculature;Primary end point(s): Ovulation<br>Improvement/deterioration in clinical symptoms: hyper androgenic features, obesity and menstrual disturbances<br>Change in ovarian doppler indicies<br>Preganancy<br>BMI<30
- Secondary Outcome Measures
Name Time Method