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OpenTrials
Completed

NCT Number: NCT01115127

Myo-inositol and Melatonin in Pre-menopausal Women

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.

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Key information

Conditions

Pre-menopausal Irregular Cycles and Bleedings

Age range

40 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University Hospital

Messina, 98100, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all pre-menopausal women with irregular cycles and bleedings

Exclusion criteria

  • pre-menopausal women who take hormonal drugs

Treatment and study plan

melatonin

Dietary Supplement

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

Myo-Inositol

Dietary Supplement

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

melatonin plus myo-inositol

Dietary Supplement

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

Primary outcomes

  1. Normalizing irregular bleeding and anovulatory cycles in pre-menopausal women.

    Time frame: 12 months

Secondary outcomes

  1. Serum assays of thyroid hormones.

    Time frame: 12 months

  2. Assays of gonadotropins and estradiol serum levels

    Time frame: 12 months

  3. Evaluation of metabolic markers (insulin, glucose, total cholesterol, HDL-cholesterol, triglycerides).

    Time frame: 12 months

  4. Variation of blood pressure.

    Time frame: 12 months

  5. Variation of mood, hot flashes, quality of sleep.

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University of Messina

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 4, 2010
Registry last updated
Mar 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.