Effects of Metformin and Oral Hormonal Contraceptive in Adolescents With Polycystic Ovary Syndrome
Status:
Unknown status
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
Summary
The polycystic ovary syndrome is the most common endocrinopathy in reproductive age women.
The pathophysiology of this syndrome remains unclear, but there are evidences that a
decreased in insulin sensitivity may be related in this syndrome. There are studies that
showed the action of factors on the sensitivity of the insulin receptor, such as melatonin.
It is a hormone produced by the pineal gland, whose role is still uncertain in human
reproduction, although many studies have found that it may relate sex hormone effect. Many
patients with polycystic ovary syndrome (PCOS) may have hyperinsulinemia, and that
pinealectomized rats determined hypoglycemia and hyperinsulinemia, with reduced release of
insulin in response to glucose. Therefore, it is supposed that blood levels of melatonin
might correlate with the blood insulin concentration in patients with the syndrome. Moreover,
the insulin sensitizing agents have been used in the treatment of patients with insulin
resistance and PCOS, based on its main pathophysiological substrate which is the
hyperinsulinemia. In fact, the metformin is the most used in the literature. However, there
are few studies on the use of metformin in adolescents. The evidences of this drugs in this
group of patients have showed good therapeutic response with few side effects. The objective
of the study is to evaluate the effects of metformin on insulin resistance and levels of
melatonin in adolescents with PCOS. It will be performed a prospective, randomized,
double-blind and placebo-controlled study with 90 adolescents with PCOS. It will be evaluated
clinical and laboratory parameters (TSH, free T4, prolactin, FSH, LH, estradiol, total
testosterone, androstenedione, DHEA-s, 17-OH progesterone, SHBG, free androgen index, index
of HOMA-IR and QUICKI from fasting glucose and insulin, total cholesterol and fractions,
triglycerides, creatinine, AST and ALT and creatinkinase, fibrinogen and PAI-1, and melatonin
for 6 months of treatment.