Myo-inositol and Melatonin in Pre-menopausal Women

Pre-menopausal Irregular Cycles and Bleedings Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01115127
• Other study ID #: Myo-Mela-2010
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 22, 2010
• Last updated: March 1, 2012
• Start date: March 2010
• Est. completion date: December 2011

Study information

• Verified date: March 2012
• Source: University of Messina
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 55 Years

Eligibility

Inclusion Criteria:

• all pre-menopausal women with irregular cycles and bleedings

Exclusion Criteria:

• pre-menopausal women who take hormonal drugs

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pre-menopausal Irregular Cycles and Bleedings

Intervention

Dietary Supplement:
• melatonin
30 subjects will take 1 tablet per day (at night-time) containing 3 grams of melatonin for 6 months
• myo-inositol
30 subjects will take 2 tablets per day containing 2 grams of myo-inositol, for 6 months.
• 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

Locations

Country	Name	City	State
Italy	University Hospital	Messina

Sponsors (1)

Lead Sponsor	Collaborator
University of Messina

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Normalizing irregular bleeding and anovulatory cycles in pre-menopausal women.		12 months	No
Secondary	Serum assays of thyroid hormones.		12 months	No
Secondary	Assays of gonadotropins and estradiol serum levels		12 months	No
Secondary	Evaluation of metabolic markers (insulin, glucose, total cholesterol, HDL-cholesterol, triglycerides).		12 months	No
Secondary	Variation of blood pressure.		12 months	No
Secondary	Variation of mood, hot flashes, quality of sleep.		12 months	Yes