Myo-inositol and Melatonin in Pre-menopausal Women

Phase 2

Completed

• Conditions: Pre-menopausal Irregular Cycles and Bleedings
• Interventions: Dietary Supplement: melatonin plus myo-inositol; Dietary Supplement: myo-inositol; Dietary Supplement: melatonin

• Registration Number: NCT01115127
• Lead Sponsor: University of Messina

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

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-04-22
• Study First Submitted QC: 2010-05-03
• Study First Posted: 2010-05-04
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-01
• Last Update Posted: 2012-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• all pre-menopausal women with irregular cycles and bleedings

Exclusion Criteria

• pre-menopausal women who take hormonal drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
melatonin plus myo-inositol	melatonin 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
myo-inositol	myo-inositol	30 subjects will take 2 tablets per day containing 2 grams of myo-inositol, for 6 months.
melatonin	melatonin	30 subjects will take 1 tablet per day (at night-time) containing 3 grams of melatonin for 6 months

Primary Outcome Measures

Name	Time	Method
Normalizing irregular bleeding and anovulatory cycles in pre-menopausal women.	12 months

Secondary Outcome Measures

Name	Time	Method
Evaluation of metabolic markers (insulin, glucose, total cholesterol, HDL-cholesterol, triglycerides).	12 months
Serum assays of thyroid hormones.	12 months
Assays of gonadotropins and estradiol serum levels	12 months
Variation of blood pressure.	12 months
Variation of mood, hot flashes, quality of sleep.	12 months

Trial Locations

Locations (1)

University Hospital; 🇮🇹 Messina, Italy