Myo-inositol and Melatonin in Pre-menopausal Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Myo-inositol and Melatonin in Menopausal Transition. A Prospective, Randomized Trial

Conditions
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Pre-menopausal Irregular Cycles and Bleedings

Intervention / Treatment
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* Dietary Supplement: melatonin
* Dietary Supplement: myo-inositol
* Dietary Supplement: melatonin plus myo-inositol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all pre-menopausal women with irregular cycles and bleedings Exclusion Criteria: pre-menopausal women who take hormonal drugs

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: myo-inositol<br>30 subjects will take 2 tablets per day containing 2 grams of myo-inositol, for 6 months. | Dietary Supplement: myo-inositol<br>* 30 subjects will take 2 tablets per day containing 2 grams of myo-inositol, for 6 months.<br>|
| Active Comparator: melatonin<br>30 subjects will take 1 tablet per day (at night-time) containing 3 grams of melatonin for 6 months | Dietary Supplement: melatonin<br>* 30 subjects will take 1 tablet per day (at night-time) containing 3 grams of melatonin for 6 months<br>|
| Active Comparator: melatonin plus myo-inositol<br>30 subjects will take 2 grams per day of myo-inositol and 3 grams of melatonin at night-time for 6 months | Dietary Supplement: melatonin plus myo-inositol<br>* 30 subjects will take 2 grams per day of myo-inositol and 3 grams of melatonin at night-time for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normalizing irregular bleeding and anovulatory cycles in pre-menopausal women. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | 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). |  | 12 months | 
| Variation of blood pressure. |  | 12 months | 
| Variation of mood, hot flashes, quality of sleep. |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pre-menopause, melatonin, myo-inositol