NCT04892186

Effects of Myo-inositol in Women With Polycystic Ovary Syndrome

Effects of Myo-inositol on the Menstrual Cycle, Hyperandrogenism, Chronic Inflammatory Process and Carbohydrate Metabolism in Women With Polycystic Ovary Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: Female
• Age: 19 Years – 36 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Polycystic Ovary Syndrome
• Resistance, Insulin
• Glucose Intolerance

Interventions

Type	Name	Description
DRUG	Myo-inositol	30 women with polycystic ovary syndrome and insulin resistance or glucose intolerance will used myo-inositol 2g + folic acid 200mcg twice daily for 6 months, having a re-evaluation every 3 months. Evaluation will be made by transvaginal ultrasound, abdominal ultrasound, inflammatory tests, hormonal tests, glycemic curve with insulin curve, lipid profile, body mass index, evaluation of abdominal and hip circumference.
DRUG	Metformin	30 women with polycystic ovary syndrome and insulin resistance or glucose intolerance will used metformin 850 mg twice a day for 6 months, having a re-evaluation every 3 months. Evaluation will be made by transvaginal ultrasound, abdominal ultrasound, inflammatory tests, hormonal tests, glycemic curve with insulin curve, lipid profile, body mass index, evaluation of abdominal and hip circumference.

Timeline

• Start date: 2021-03-26
• Primary completion: 2023-10-20
• Completion: 2023-10-20
• First posted: 2021-05-19
• Last updated: 2024-02-20

Locations

2 sites across 1 country: Brazil