Clinical trial NCT04892186: Effects of Myo-inositol in Women With Polycystic Ovary Syndrome
Official title: Effects of Myo-inositol on the Menstrual Cycle, Hyperandrogenism, Chronic Inflammatory Process and Carbohydrate Metabolism in Women With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Resistance, Insulin
Glucose Intolerance
Keywords: myo-inositol
metformin
polycystic ovary syndrome
resistance insulin
glucose intolerance
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2021-05-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Menstrual cycle
timeFrame: 6 months
measure: Change in glucose metabolism
timeFrame: Every 3 months for up to 6 months
measure: Change in glycated hemoglobin
timeFrame: Every 3 months for up to 6 months
measure: Change in ultrasound of the ovaries
timeFrame: 6 months
measure: Change in antral follicle count
timeFrame: 6 months
measure: Change in body mass index
timeFrame: Every 3 months for up to 6 months
measure: Change in Abdominal Circumference and Hip Circumference
timeFrame: Every 3 months for up to 6 months
measure: Change in body weight in kilograms
timeFrame: Every 3 months for up to 6 months
Secondary outcomes:
measure: Assess adherence to treatment.
timeFrame: Every 3 months for up to 6 months
measure: Side effects
timeFrame: Every 3 months for up to 6 months
measure: Hepatic steatosis
timeFrame: 6 months
measure: Liver enzymes
timeFrame: 6 months
measure: Chronic inflammatory process
timeFrame: 6 months
measure: C-reactive protein
timeFrame: 6 months
measure: Homocysteine
timeFrame: 6 months
measure: Change in Lipid Profile
timeFrame: Every 3 months for up to 6 months
measure: Modified Ferriman-Gallwey Score
timeFrame: 6 months
measure: Hormonal dosage (FSH, LH, progesterone, estradiol)
timeFrame: 6 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital Das Clinicas - Fmusp
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Study officials:
affiliation: research coordinator
name: Edmund Chada Baracat, Phd
role: PRINCIPAL_INVESTIGATOR
References: