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Myo-inositol and Melatonin in Pre-menopausal Women

NCT01115127 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2012-03-02

No results posted yet for this study

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.

Conditions

  • Pre-menopausal Irregular Cycles and Bleedings

Interventions

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

Sponsors & Collaborators

  • University of Messina

    lead OTHER

Principal Investigators

  • Rosario D'Anna, MD · University of Messina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01115127 on ClinicalTrials.gov