Effects of Myo-inositol in Women With Polycystic Ovary Syndrome

Last updated: February 15, 2024
Sponsor: University of Sao Paulo General Hospital
Overall Status: Completed

Phase

N/A

Condition

Diabetes And Hypertension

Hypertriglyceridemia

Diabetes Mellitus Types I And Ii

Treatment

Myo-inositol

Metformin

Clinical Study ID

NCT04892186
CAAE: 23458719.6.0000.0068
  • Ages 19-36
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 diabetesmellitus);
  • FSH (Follicle Stimulating Hormone) > 15 Ul / L (2nd to 5th day of the cycle);
  • Beta-hcG (human chorionic gonadotropin) positive (pregnancy).

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Myo-inositol
Phase:
Study Start date:
March 26, 2021
Estimated Completion Date:
October 20, 2023

Study 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.

Connect with a study center

  • Hospital Das Clinicas - Fmusp

    Sao Paulo, 05403000
    Brazil

    Site Not Available

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

    Sao Paulo, 05403000
    Brazil

    Site Not Available

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