Pre-menopausal Irregular Cycles and Bleedings
Conditions
Keywords
pre-menopause, melatonin, myo-inositol
Brief summary
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.
Detailed description
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
Interventions
DIETARY_SUPPLEMENTmelatonin
30 subjects will take 1 tablet per day (at night-time) containing 3 grams of melatonin for 6 months
DIETARY_SUPPLEMENTmyo-inositol
30 subjects will take 2 tablets per day containing 2 grams of myo-inositol, for 6 months.
DIETARY_SUPPLEMENTmelatonin plus myo-inositol
30 subjects will take 2 grams per day of myo-inositol and 3 grams of melatonin at night-time for 6 months
Sponsors
University of Messina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* all pre-menopausal women with irregular cycles and bleedings
Exclusion criteria
* pre-menopausal women who take hormonal drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Normalizing irregular bleeding and anovulatory cycles in pre-menopausal women. | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Serum assays of thyroid hormones. | 12 months |
| Assays of gonadotropins and estradiol serum levels | 12 months |
| Evaluation of metabolic markers (insulin, glucose, total cholesterol, HDL-cholesterol, triglycerides). | 12 months |
| Variation of blood pressure. | 12 months |
| Variation of mood, hot flashes, quality of sleep. | 12 months |
Countries
Italy
Outcome results
None listed