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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| myo-inositol | Active Comparator | 30 subjects will take 2 tablets per day containing 2 grams of myo-inositol, for 6 months. |
|
| melatonin | Active Comparator | 30 subjects will take 1 tablet per day (at night-time) containing 3 grams of melatonin for 6 months |
|
| melatonin plus myo-inositol | Active Comparator | 30 subjects will take 2 grams per day of myo-inositol and 3 grams of melatonin at night-time for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| melatonin | Dietary Supplement | 30 subjects will take 1 tablet per day (at night-time) containing 3 grams of melatonin for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Normalizing irregular bleeding and anovulatory cycles in pre-menopausal women. | 12 months |
| Measure | Description | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rosario D'Anna, MD | University of Messina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Messina | 98100 | Italy |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| D007294 | Inositol |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| myo-inositol | Dietary Supplement | 30 subjects will take 2 tablets per day containing 2 grams of myo-inositol, for 6 months. |
|
| melatonin plus myo-inositol | Dietary Supplement | 30 subjects will take 2 grams per day of myo-inositol and 3 grams of melatonin at night-time for 6 months |
|
| 12 months |
| Variation of blood pressure. | 12 months |
| Variation of mood, hot flashes, quality of sleep. | 12 months |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |