Effect of Metformin Therapy on Insulin Resistance and Melatonin in Adolescents With Polycystic Ovary Syndrome.
Design: 90 patients will be selected to a prospective, randomized and double-blinded study.
They will be assigned to two groups: A) 45 patients, treated with OC (oral contraceptive)
and metformin 1500mg/ day. B) 45 patients, treated with OC and placebo. The length of
treatment was six months.
Inclusion criteria: patients until 19 years-old, at least 2 years after menarche, with
Polycystic Ovary Syndrome based on Rotterdan criterion. Exclusion criteria: patients with
Diabetes Mellitus, hypertension, hyperprolactinemia, adrenal enzymatic deficiency, Cushing
syndrome, thyroidopathy, renal or hepatic disfunction, use of OC or insulin-sensitising
drugs in the last 90 days before, pregnancy, androgen tumors, hormonal-sensitive tumors in
the past, contra-indication to the medications used in the study.
Clinical parameters included are weight and height (for BMI), waist to hip ratio, habits
like smoking or drinking, drug addiction, blood pressure measurement, hirsutism and acne.
Laboratorial parameters included are TSH, free T4, prolactin, FSH, LH, estradiol, total
testosterone, androstenedione, s-DHEA, 17-OH progesterone, SHBG, free androgen index,
fasting glucose and insulin, total cholesterol and fractions, triglycerides, creatinin, TGO,
TGP, CK, PAI-1, fibrinogen, melatonin.
Patients will be evaluated using these parameters in the beginning, 1, 3 and 6 months after
use of the drugs.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
0 and 6 months
Jose Maria Soares Junior
Federal University os Sao Paulo
Brazil: National Committee of Ethics in Research