Myo-inositol and Melatonin in Pre-menopausal Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rosario D'anna, University of Messina
ClinicalTrials.gov Identifier:
NCT01115127
First received: April 22, 2010
Last updated: March 1, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Pre-menopausal Irregular Cycles and Bleedings
Dietary Supplement: melatonin
Dietary Supplement: myo-inositol
Dietary Supplement: melatonin plus myo-inositol
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Myo-inositol and Melatonin in Menopausal Transition. A Prospective, Randomized Trial

Resource links provided by NLM:


Further study details as provided by University of Messina:

Primary Outcome Measures:
  • Normalizing irregular bleeding and anovulatory cycles in pre-menopausal women. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum assays of thyroid hormones. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Assays of gonadotropins and estradiol serum levels [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Evaluation of metabolic markers (insulin, glucose, total cholesterol, HDL-cholesterol, triglycerides). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Variation of blood pressure. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Variation of mood, hot flashes, quality of sleep. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 90
Study Start Date: March 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   40 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all pre-menopausal women with irregular cycles and bleedings

Exclusion Criteria:

  • pre-menopausal women who take hormonal drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01115127

Locations
Italy
University Hospital
Messina, Italy, 98100
Sponsors and Collaborators
University of Messina
Investigators
Principal Investigator: Rosario D'Anna, MD University of Messina
  More Information

No publications provided

Responsible Party: Rosario D'anna, Myo-inositol and melatonin in menopausal transition., University of Messina
ClinicalTrials.gov Identifier: NCT01115127     History of Changes
Other Study ID Numbers: Myo-Mela-2010
Study First Received: April 22, 2010
Last Updated: March 1, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by University of Messina:
pre-menopause
melatonin
myo-inositol

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Inositol
Melatonin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 18, 2014