Effects of Myo-inositol in Women With Polycystic Ovary Syndrome

Sponsor
University of Sao Paulo General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04892186
Collaborator
(none)
60
2
2
13.2
30
2.3

Study Details

Study Description

Brief 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 18 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 by the entity The Androgen Excess and Polycystic Ovary Syndrome Society (AE-PCOS) 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, orally, three times a day; Group II (experiment) - they will receive myo-inositol 2g, orally, twice a day.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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, orally, three times a day; Group II (experiment) - they will receive myo-inositol 2g, orally, twice a day.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, orally, three times a day; Group II (experiment) - they will receive myo-inositol 2g, orally, twice a day.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of Myo-inositol on the Menstrual Cycle, Hyperandrogenism, Chronic Inflammatory Process and Carbohydrate Metabolism in Women With Polycystic Ovary Syndrome
Actual Study Start Date :
May 26, 2021
Anticipated Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Myo-inositol

30 women with resistance insulin or glucose intolerance will receive myo-inositol 2g, 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 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, orally, three times a day for 6 months

Drug: Metformin
30 women with polycystic ovary syndrome and insulin resistance or glucose intolerance will used metformin three times 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.

Outcome Measures

Primary Outcome Measures

  1. Menstrual cycle [6 months]

    Analysis of period calendar.

  2. Change in glucose metabolism [Every 3 months for up to 6 months]

    Glucose tolerance curve with insulin curve will be performed every 3 months.

  3. Change in glycated hemoglobin [Every 3 months for up to 6 months]

    Glycated hemoglobin will be performed every 3 months.

  4. Change in ultrasound of the ovaries [6 months]

    Transvaginal ultrasound to assess ovarian volume (measured in cubic centimeters) will be done before and after treatment.

  5. Change in antral follicle count [6 months]

    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. Change in body mass index [Every 3 months for up to 6 months]

    Body mass index (kg/m2) will be assessed every 3 months.

  7. Change in Abdominal Circumference and Hip Circumference [Every 3 months for up to 6 months]

    Abdominal circumference and hip circumference (measured in centimeters) will be assessed every 3 months.

  8. Change in body weight in kilograms [Every 3 months for up to 6 months]

    Patients will be weighed every 3 months (measured in kilograms).

Secondary Outcome Measures

  1. Assess adherence to treatment. [Every 3 months for up to 6 months]

    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).

  2. Side effects [Every 3 months for up to 6 months]

    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.

  3. Hepatic steatosis [6 months]

    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).

  4. Liver enzymes [6 months]

    Liver enzymes (aspartate aminotransferase, alanine aminotransferase,alkaline phosphatase) will be collected before and after treatment

  5. Chronic inflammatory process [6 months]

    Chronic inflammatory markers will be accessed by analyzing RNA messenger from cervical-vaginal cytology before and after treatment.

  6. C-reactive protein [6 months]

    Chronic inflammatory process will be also evaluated by serum measurement of c-reactive protein before and after treatment.

  7. Homocysteine [6 months]

    Serum homocysteine dosage will be done before and after treatment to help assess a chronic inflammatory process.

  8. Change in Lipid Profile [Every 3 months for up to 6 months]

    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

  9. Modified Ferriman-Gallwey Score [6 months]

    Modified Ferriman-Gallwey Score will be performed before and after treatment and patients with a score above 7 will be considered hirsute.

  10. Hormonal dosage (FSH, LH, progesterone, estradiol) [6 months]

    Hormonal dosage (FSH - Follicle-stimulating hormone, LH - luteinizing hormone, progesterone, estradiol) will be preformed before and after treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 36 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Women aged 18 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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Das Clinicas - Fmusp Sao Paulo Brazil 05403000
2 Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo Sao Paulo Brazil 05403000

Sponsors and Collaborators

  • University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Edmund Chada Baracat, Phd, research coordinator

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT04892186
Other Study ID Numbers:
  • CAAE: 23458719.6.0000.0068
First Posted:
May 19, 2021
Last Update Posted:
Mar 18, 2022
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by University of Sao Paulo General Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 18, 2022