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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Other trials in Brazil

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.

Conditions: Polycystic Ovary Syndrome, Resistance, Insulin, Glucose Intolerance
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 groups in NCT04892186
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.

26 Mar 202120 Oct 2023

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Active, not recruiting
Mindfulness-Based Education For Women With Polycystic Ovary Syndrome
Polycystic Ovary Syndrome (PCOS), Menstrual Symptoms
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)

All Polycystic Ovary Syndrome trials

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
Conditions: Polycystic Ovary Syndrome, Resistance, Insulin, Glucose Intolerance
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.

Detailed description

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

Related trials for Polycystic Ovary Syndrome

Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Active, not recruiting
Mindfulness-Based Education For Women With Polycystic Ovary Syndrome
Polycystic Ovary Syndrome (PCOS), Menstrual Symptoms
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)

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?

On the ClinicalTrials.gov record for NCT04892186.

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; AzTrials last refreshed its copy on 9 Nov 2026.