Myo-inositol Plus Melatonin in Perimenopausal Women
|ClinicalTrials.gov Identifier: NCT01325389|
Recruitment Status : Unknown
Verified March 2011 by AGUNCO Obstetrics and Gynecology Centre.
Recruitment status was: Recruiting
First Posted : March 29, 2011
Last Update Posted : March 29, 2011
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 or disease||Intervention/treatment||Phase|
|Perimenopause||Dietary Supplement: Myo-Mel Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effects of Myo-inositol Plus Melatonin in Perimenopausal Women|
Patients are treated with 2g of myo + 3mg of melatonin daily
|Dietary Supplement: Myo-Mel|
|Placebo Comparator: Placebo||Dietary Supplement: Placebo|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01325389
|Rome, Italy, 00155|
|Contact: Gianfranco Carlomagno, Ph.D. firstname.lastname@example.org|
|Principal Investigator: Gianfranco Carlomagno, Ph.D|
|Principal Investigator: Vittorio Unfer, M.D.|