Effects of Myo-inositol in Women With Polycystic Ovary Syndrome

University of Sao Paulo General Hospital

Status: Completed

Conditions: Polycystic Ovary Syndrome; Resistance, Insulin; Glucose Intolerance

Treatments: Drug: Metformin; Drug: Myo-inositol

Study type: Interventional

Funder types: Other

Identifiers

NCT04892186

CAAE: 23458719.6.0000.0068

Details and patient eligibility

About

The study will be carried out at the hospital of the medical school of sao paulo (HC-FMUSP) and the goal is to compare the effects of the administration of myo-inositol in relation to the effects of metformin in women with Polycystic Ovary Syndrome and insulin resistance or glucose intolerance. Menstrual cycle, hyperandrogenism, chronic inflammatory process, carbohydrate metabolism, hepatic steatosis will be evaluated. In total, 60 women in the reproductive period, with a variable age between 18 and 36 years old will be recruited and randomized in two groups: intervention- myo-inositol for 6 months, control group will use metformin also for 6 months.

Full description

The study will involve 60 women in the reproductive period, with a variable between 19 and 36 years old and diagnosed with polycystic ovary syndrome (PCOS), according to Rotterdam- European Society of Human Reproduction and Embryology (ESHRE) / American Society for Reproductive Medicine (ASRM) criteria defined in 2003 and revised in 2018, and insulin resistance (presence acanthosis nigricans) or glucose intolerance (fasting glycemia, glycated hemoglobin or 75g glycemic overload and blood glucose assessment after 2 hours). It is a comparative and non-inferiority study of myo-inositol in relation to metformin. They will be divided into two groups of 30 patients: Group I (control) - they will receive metformin 850 mg, orally, twice a day; Group II (experiment) - they will receive myo-inositol 2g + folic acid 200mcg, orally, twice a day.

Enrollment: 60 patients

Sex: Female

Ages: 19 to 36 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women aged 19 to 36 with diagnosis of PCOS and insulin resistance or glucose intolerance.

Exclusion criteria

• Previous use of any hormonal treatment in the past three months;
• Other causes of anovulation;
• Gynecological or other associated conditions (endometriosis, adenomyosis or diabetes mellitus);
• FSH (Follicle Stimulating Hormone) > 15 Ul / L (2nd to 5th day of the cycle);
• Beta-hcG (human chorionic gonadotropin) positive (pregnancy).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Myo-inositol

Experimental group

Description:

30 women with resistance insulin or glucose intolerance will receive myo-inositol 2g + folic acid 200mcg, orally, twice a day for 6 months.

Treatment:

Drug: Myo-inositol

Metformin

Active Comparator group

Description:

30 women with resistance insulin or glucose intolerance will receive metformin 850 mg, orally, twice a day for 6 months

Treatment:

Drug: Metformin