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Myo-inositol Plus Melatonin in Perimenopausal Women

NCT01325389 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2011-03-29

No results posted yet for this study

Summary

Menopause is the milestone of a more broaden condition that can last up to 10 years. The first menopausal symptoms usually appear around the age of 42 and are characterized by a gradual decline in thyroid and gonadal function with a progressive increase of plasmatic luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels.

Recent studies have shown that myo-inositol and melatonin play a major role in ovarian homeostasis. In particular, it has been demonstrated that myo-inositol and/or melatonin supplementation lead to an increase of oocyte quality.

Additional studies focused on postmenopausal women have shown that myo-inositol is able to ameliorate the metabolic syndrome that often affects these patients, thus reducing the risk of cardiovascular diseases (CVDs).

The aim of the present study is to evaluate whether myo-inositol and melatonin might play a positive role in regulating hormonal levels during menopausal onset.

Conditions

  • Perimenopause

Interventions

DIETARY_SUPPLEMENT

Myo-Mel

DIETARY_SUPPLEMENT

Placebo

Sponsors & Collaborators

  • AGUNCO Obstetrics and Gynecology Centre

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
42 Years
Max Age
48 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Countries

  • Italy

Study Locations

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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 NCT01325389 on ClinicalTrials.gov