Myo-inositol Plus Melatonin in Perimenopausal Women

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by AGUNCO Obstetrics and Gynecology Centre.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
AGUNCO Obstetrics and Gynecology Centre
ClinicalTrials.gov Identifier:
NCT01325389
First received: March 28, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Perimenopause
Dietary Supplement: Myo-Mel
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Effects of Myo-inositol Plus Melatonin in Perimenopausal Women

Resource links provided by NLM:


Further study details as provided by AGUNCO Obstetrics and Gynecology Centre:

Arms Assigned Interventions
Experimental: Myo+Mel
Patients are treated with 2g of myo + 3mg of melatonin daily
Dietary Supplement: Myo-Mel
Placebo Comparator: Placebo Dietary Supplement: Placebo

  Eligibility

Ages Eligible for Study:   42 Years to 48 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • FSH between 15 and 50 IU/ml on the 5th day of the menses
  • Oligomenorrhea

Exclusion Criteria:

-

  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: NCT01325389

Locations
Italy
AGUNCO Recruiting
Rome, Italy, 00155
Contact: Gianfranco Carlomagno, Ph.D.       gianfranco.carlomagno@gmail.com   
Principal Investigator: Gianfranco Carlomagno, Ph.D         
Principal Investigator: Vittorio Unfer, M.D.         
Sponsors and Collaborators
AGUNCO Obstetrics and Gynecology Centre
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT01325389     History of Changes
Other Study ID Numbers: Myo+MEL_peri_women
Study First Received: March 28, 2011
Last Updated: March 28, 2011
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 16, 2014