Myo-inositol and Melatonin in Pre-menopausal Women

March 1, 2012 updated by: Rosario D'anna, University of Messina

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Messina, Italy, 98100
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • all pre-menopausal women with irregular cycles and bleedings

Exclusion Criteria:

  • pre-menopausal women who take hormonal drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: myo-inositol
30 subjects will take 2 tablets per day containing 2 grams of myo-inositol, for 6 months.
Dietary supplement: myo-inositol
30 subjects will take 2 tablets per day containing 2 grams of myo-inositol, for 6 months.
Active Comparator: melatonin
30 subjects will take 1 tablet per day (at night-time) containing 3 grams of melatonin for 6 months
Dietary supplement: melatonin
30 subjects will take 1 tablet per day (at night-time) containing 3 grams of melatonin for 6 months
Active Comparator: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Normalizing irregular bleeding and anovulatory cycles in pre-menopausal women.
Time Frame: 12 months
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Messina

Investigators

  • Principal Investigator: Rosario D'Anna, MD, University of Messina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

April 22, 2010

First Submitted That Met QC Criteria

May 3, 2010

First Posted (Estimate)

May 4, 2010

Study Record Updates

Last Update Posted (Estimate)

March 2, 2012

Last Update Submitted That Met QC Criteria

March 1, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Myo-Mela-2010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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