Polycystic Ovary SyndromeNCT04892186
Effects of Myo-inositol in Women With Polycystic Ovary Syndrome
A study testing Myo-inositol and Metformin in people with Polycystic Ovary Syndrome and Resistance, Insulin, run by University of Sao Paulo General Hospital at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 36 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Resistance, Insulin, Glucose Intolerance
- What is being tested?
- Myo-inositol and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesBrazil
- Study dates
- 26 Mar 2021to 20 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 36 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 19 to 36 with diagnosis of PCOS and insulin resistance or glucose intolerance.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Hospital Das Clinicas - Fmusp
São Paulo, 05403000
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, 05403000
About this study
Official title: 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.
Read the 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.
- Being tested
- Myo-inositol, Metformin
- Keywords
- myo-inositol, metformin, polycystic ovary syndrome, resistance insulin, glucose intolerance
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myo-inositolDrug
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.
MetforminDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Myo-inositol | Experimental | 30 women with resistance insulin or glucose intolerance will receive myo-inositol 2g + folic acid 200mcg, orally, twice a day for 6 months. Receives: Drug: Myo-inositol |
| Metformin | Active comparator | 30 women with resistance insulin or glucose intolerance will receive metformin 850 mg, orally, twice a day for 6 months Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menstrual cycle
Analysis of period calendar.
Measured: 6 months
Change in glucose metabolism
Glucose tolerance curve with insulin curve will be performed every 3 months.
Measured: Every 3 months for up to 6 months
Change in glycated hemoglobin
Glycated hemoglobin will be performed every 3 months.
Measured: 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.
Measured: 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)
Measured: 6 months
Change in body mass index
Body mass index (kg/m2) will be assessed every 3 months.
Measured: 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.
Measured: Every 3 months for up to 6 months
Change in body weight in kilograms
Patients will be weighed every 3 months (measured in kilograms).
Measured: Every 3 months for up to 6 months
Secondary outcomes (10)
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).
Measured: 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.
Measured: 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).
Measured: 6 months
Liver enzymes
Liver enzymes (aspartate aminotransferase, alanine aminotransferase,alkaline phosphatase) will be collected before and after treatment
Measured: 6 months
Chronic inflammatory process
Chronic inflammatory markers will be accessed by analyzing RNA messenger from cervical-vaginal cytology before and after treatment.
Measured: 6 months
C-reactive protein
Chronic inflammatory process will be also evaluated by serum measurement of c-reactive protein before and after treatment.
Measured: 6 months
Homocysteine
Serum homocysteine dosage will be done before and after treatment to help assess a chronic inflammatory process.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start26 Mar 2021
- Primary completion20 Oct 2023
- Study completion20 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edmund Chada Baracat, Phd, Principal investigator, research coordinator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892186
- Sponsor's protocol ID
- CAAE: 23458719.6.0000.0068
- Status last verified
- Oct 2023
- First submitted
- 8 Mar 2021
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Myo-inositol on the Menstrual Cycle, Hyperandrogenism, Chronic Inflammatory Process and Carbohydrate Metabolism in Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT04892186
- Acronym / sponsor ID
- CAAE: 23458719.6.0000.0068
- Keywords
- myo-inositol, metformin, polycystic ovary syndrome, resistance insulin, glucose intolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 19 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Myo-inositol | Experimental | Drug: Myo-inositol30 women with resistance insulin or glucose intolerance will receive myo-inositol 2g + folic acid 200mcg, orally, twice a day for 6 months. |
| Metformin | Active comparator | Drug: Metformin30 women with resistance insulin or glucose intolerance will receive metformin 850 mg, orally, twice a day for 6 months |
Who may qualify
- Ages
- 19 to 36 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women aged 19 to 36 with diagnosis of PCOS and insulin resistance or glucose intolerance.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myo-inositol30 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 | Myo-inositol |
| Metformin30 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. | Drug | Metformin |
Primary outcome
Menstrual cycle
Time frame: 6 months
Analysis of period calendar.
Change in glucose metabolism
Time frame: Every 3 months for up to 6 months
Glucose tolerance curve with insulin curve will be performed every 3 months.
Change in glycated hemoglobin
Time frame: Every 3 months for up to 6 months
Glycated hemoglobin will be performed every 3 months.
Change in ultrasound of the ovaries
Time frame: 6 months
Transvaginal ultrasound to assess ovarian volume (measured in cubic centimeters) will be done before and after treatment.
Change in antral follicle count
Time frame: 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)
Change in body mass index
Time frame: Every 3 months for up to 6 months
Body mass index (kg/m2) will be assessed every 3 months.
Change in Abdominal Circumference and Hip Circumference
Time frame: Every 3 months for up to 6 months
Abdominal circumference and hip circumference (measured in centimeters) will be assessed every 3 months.
Change in body weight in kilograms
Time frame: Every 3 months for up to 6 months
Patients will be weighed every 3 months (measured in kilograms).
10 secondary outcomes
Assess adherence to treatment.
Time frame: Every 3 months for up to 6 months
Side effects
Time frame: Every 3 months for up to 6 months
Hepatic steatosis
Time frame: 6 months
Liver enzymes
Time frame: 6 months
Chronic inflammatory process
Time frame: 6 months
C-reactive protein
Time frame: 6 months
Homocysteine
Time frame: 6 months
Change in Lipid Profile
Time frame: Every 3 months for up to 6 months
Modified Ferriman-Gallwey Score
Time frame: 6 months
Hormonal dosage (FSH, LH, progesterone, estradiol)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edmund Chada Baracat, Phd principal investigator
research coordinator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myo-inositol and Metformin in people with Polycystic Ovary Syndrome and Resistance, Insulin, run by University of Sao Paulo General Hospital at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menstrual cycle (time frame: 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.