Myo-inositol Plus Melatonin in Perimenopausal Women

AGUNCO Obstetrics and Gynecology Centre

Status: Unknown

Conditions: Perimenopause

Treatments: Dietary Supplement: Myo-Mel; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01325389

Myo+MEL_peri_women

Details and patient eligibility

About

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.

Sex: Female

Ages: 42 to 48 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Myo+Mel

Experimental group

Description:

Patients are treated with 2g of myo + 3mg of melatonin daily

Treatment:

Dietary Supplement: Myo-Mel

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo