Myo-inositol Plus Melatonin in Perimenopausal Women

Not Applicable

• Conditions: Perimenopause
• Interventions: Dietary Supplement: Myo-Mel; Dietary Supplement: Placebo

• Registration Number: NCT01325389
• Lead Sponsor: AGUNCO Obstetrics and Gynecology Centre

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-03
• Study First Submitted: 2011-03-28
• Study First Submitted QC: 2011-03-28
• Last Update Submitted: 2011-03-28
• Study First Posted: 2011-03-29
• Last Update Posted: 2011-03-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Myo+Mel	Myo-Mel	Patients are treated with 2g of myo + 3mg of melatonin daily
Placebo	Placebo	-

Trial Locations

Locations (1)

AGUNCO; 🇮🇹 Rome, Italy