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

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.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome; Glucose Intolerance; Resistance, Insulin
• Intervention / Treatment: Drug: Myo-inositol; Drug: Metformin

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05403000
    • Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo
  • Sao Paulo, Brazil, 05403000
    • Hospital das Clinicas - FMUSP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 36 years (Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Myo-inositol; 30 women with resistance insulin or glucose intolerance will receive myo-inositol 2g + folic acid 200mcg, orally, twice a day for 6 months.	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.
Active Comparator: Metformin; 30 women with resistance insulin or glucose intolerance will receive metformin 850 mg, orally, twice a day for 6 months	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Menstrual cycle	Analysis of period calendar.	6 months
Change in glucose metabolism	Glucose tolerance curve with insulin curve will be performed every 3 months.	Every 3 months for up to 6 months
Change in glycated hemoglobin	Glycated hemoglobin will be performed every 3 months.	Every 3 months for up to 6 months
Change in ultrasound of the ovaries	Transvaginal ultrasound to assess ovarian volume (measured in cubic centimeters) will be done before and after treatment.	6 months
Change in antral follicle count	Ultrasound of the ovaries will be done before and after treatment for antral follicle count (all follicles from 2 to 9 mm will be measured)	6 months
Change in body mass index	Body mass index (kg/m2) will be assessed every 3 months.	Every 3 months for up to 6 months
Change in Abdominal Circumference and Hip Circumference	Abdominal circumference and hip circumference (measured in centimeters) will be assessed every 3 months.	Every 3 months for up to 6 months
Change in body weight in kilograms	Patients will be weighed every 3 months (measured in kilograms).	Every 3 months for up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess adherence to treatment.	Medication use diary will be delivered and will be reviewed every 3 months to assess adherence to treatment (good adherence will be considered use of more than 80% of the medication provided).	Every 3 months for up to 6 months
Side effects	Questionnaire will be carried out every 3 months for patient to describe the 3 main side effects and how much they have hindered the treatment or not.	Every 3 months for up to 6 months
Hepatic steatosis	Initial liver ultrasound will be done and repeated after 6 months of treatment to assess the presence or absence of hepatic steatosis and classify it as mild (grade 1), moderate (grade 2) and severe (grade 3).	6 months
Liver enzymes	Liver enzymes (aspartate aminotransferase, alanine aminotransferase,alkaline phosphatase) will be collected before and after treatment	6 months
Chronic inflammatory process	Chronic inflammatory markers will be accessed by analyzing RNA messenger from cervical-vaginal cytology before and after treatment.	6 months
C-reactive protein	Chronic inflammatory process will be also evaluated by serum measurement of c-reactive protein before and after treatment.	6 months
Homocysteine	Serum homocysteine dosage will be done before and after treatment to help assess a chronic inflammatory process.	6 months
Change in Lipid Profile	Serum dosage of the lipid profile (high density lipoprotein - HDL, low density lipoprotein - LDL , very low density lipoprotein - VLDL, triglycerides, total cholesterol) will be done every 3 months	Every 3 months for up to 6 months
Modified Ferriman-Gallwey Score	Modified Ferriman-Gallwey Score will be performed before and after treatment and patients with a score above 7 will be considered hirsute.	6 months
Hormonal dosage (FSH, LH, progesterone, estradiol)	Hormonal dosage (FSH - Follicle-stimulating hormone, LH - luteinizing hormone, progesterone, estradiol) will be preformed before and after treatment.	6 months

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: Edmund Chada Baracat, Phd, Research coordinator

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2021
• Primary Completion (Actual): October 20, 2023
• Study Completion (Actual): October 20, 2023

Study Registration Dates

• First Submitted: March 8, 2021
• First Submitted That Met QC Criteria: May 13, 2021
• First Posted (Actual): May 19, 2021

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: polycystic ovary syndrome; metformin; glucose intolerance; myo-inositol; resistance insulin
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Hyperinsulinism; Hyperglycemia; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Polycystic Ovary Syndrome; Syndrome; Glucose Intolerance; Insulin Resistance; Hypoglycemic Agents; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex; Metformin; Inositol
• Other Study ID Numbers: CAAE: 23458719.6.0000.0068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No