NCT01115127

Myo-inositol and Melatonin in Pre-menopausal Women

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: University of Messina · Academic / Other
• Sex: Female
• Age: 40 Years – 55 Years
• Healthy volunteers: Not accepted

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

Conditions

• Pre-menopausal Irregular Cycles and Bleedings

Interventions

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

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2010-05-04
• Last updated: 2012-03-02

Locations

1 site across 1 country: Italy