Myo-inositol and Melatonin in Pre-menopausal Women

University of Messina

Status and phase: Completed; Phase 3; Phase 2

Conditions: Pre-menopausal Irregular Cycles and Bleedings

Treatments: Dietary Supplement: melatonin plus myo-inositol; Dietary Supplement: melatonin; Dietary Supplement: myo-inositol

Study type: Interventional

Funder types: Other

Identifiers

NCT01115127

Myo-Mela-2010

Details and patient eligibility

About

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.

Full 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

Enrollment: 90 patients

Sex: Female

Ages: 40 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• all pre-menopausal women with irregular cycles and bleedings

Exclusion criteria

• pre-menopausal women who take hormonal drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

myo-inositol

Active Comparator group

Description:

30 subjects will take 2 tablets per day containing 2 grams of myo-inositol, for 6 months.

Treatment:

Dietary Supplement: myo-inositol

melatonin

Active Comparator group

Description:

30 subjects will take 1 tablet per day (at night-time) containing 3 grams of melatonin for 6 months

Treatment:

Dietary Supplement: melatonin

melatonin plus myo-inositol

Active Comparator group

Description:

30 subjects will take 2 grams per day of myo-inositol and 3 grams of melatonin at night-time for 6 months

Treatment:

Dietary Supplement: melatonin plus myo-inositol