Pre-menopausal Irregular Cycles and Bleedings Clinical Trial
Official title:
Myo-inositol and Melatonin in Menopausal Transition. A Prospective, Randomized Trial
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
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment