Effect of Flutamide and Metformin administered in dieting overweight-obese women with polycystic ovary syndrome
Phase 3
- Conditions
- Polycistic overian syndrome.Polycistic overian syndrome
- Registration Number
- IRCT138807271760N3
- Lead Sponsor
- Vice Chancellor for Research and Technology, Babol University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 80
Inclusion Criteria
Reproductive age (range 18-45 yr), body mass index (BMI) at least 28 kg/m2, and waist circumference at least 88 cm, chronic an ovulation severe oligomorrhea or amenorrhea, hirsutism (Ferriman – Gallwey score 8), total testosterone levels at least 0.72 ng/ml and polycystic ovarian morphology at ultrasound. Exclusion criteria: Use of any medication or a significant modification in body weight within the previous 3 months or dieting, hyperprolactinemia, cushing’s syndrome, late–onset congenital adrenal hyperplasia, thyroid dysfunction, diabetes, cardiovascular, renal or Liver diseases, positive pregnancy test.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Anthropometric measurement. Timepoint: monthly. Method of measurement: physical examination.
- Secondary Outcome Measures
Name Time Method Serum Lipid. Timepoint: monthly. Method of measurement: Lab.;Serum glucose. Timepoint: monthly. Method of measurement: lab.;Fasting insulin. Timepoint: 6 months. Method of measurement: lab.;Testosteroe, OHEA, SHBG. Timepoint: 6 months. Method of measurement: lab.;Hirsotism. Timepoint: 6 months. Method of measurement: physical examination.