The purpose of this study is to determine whether myo-inositol and melatonin, or myo-inositol alone, or melatonin alone, are effective in normalizing irregular bleeding and anovulatory cycles in pre-menopausal women.
Melatonin has produced a remarkable significant improvement of thyroid function, positive changes of gonadotropins towards reduced levels, and in some women a re-acquisition of normal menstrual cycle. Furthermore, an abrogation of menopause-related depression, amelioration of hot-flashes and improvement of quality and duration of sleep has been reported. Myo-inositol is involved in several aspects of human reproduction. Elevated concentrations of myo-inositol in human follicular fluids appear to play a positive function in follicular maturity and provide a marker of good quality oocytes. Nevertheless its positive role in PCOS women is a consequence of a defect in the insulin signalling pathway (inositol-containing phosphoglycan mediators) that seems to be primarily implicated in the pathogenesis of insulin resistance
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
30 subjects will take 1 tablet per day (at night-time) containing 3 grams of melatonin for 6 months
30 subjects will take 2 tablets per day containing 2 grams of myo-inositol, for 6 months.
30 subjects will take 2 grams per day of myo-inositol and 3 grams of melatonin at night-time for 6 months
University Hospital
Messina, Italy
Normalizing irregular bleeding and anovulatory cycles in pre-menopausal women.
Time frame: 12 months
Serum assays of thyroid hormones.
Time frame: 12 months
Assays of gonadotropins and estradiol serum levels
Time frame: 12 months
Evaluation of metabolic markers (insulin, glucose, total cholesterol, HDL-cholesterol, triglycerides).
Time frame: 12 months
Variation of blood pressure.
Time frame: 12 months
Variation of mood, hot flashes, quality of sleep.
Time frame: 12 months
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