Inositol for Polycystic Ovary Syndrome

(INSUPP-PCOS Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Richard S. Legro, M.D.

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Milton S. Hershey Medical Center

Must not be taking: Metformin, Hormonal contraceptives

Disqualifiers: Hyperprolactinemia, Cushing's syndrome, others

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests if inositol, a dietary supplement, can reduce high hormone levels in women with PCOS. It aims to see if inositol can lower testosterone and improve symptoms by balancing hormone levels. Inositol has been shown to improve ovarian function and metabolic profiles in women with PCOS, with myo-inositol (MI) and D-chiro-inositol (DCI) being particularly effective.

Will I have to stop taking my current medications?

Yes, you will need to stop taking medications that affect ovarian function, such as metformin, hormonal contraceptives, or other medications for type 2 diabetes, to participate in this trial.

What data supports the effectiveness of the treatment Inositol for Polycystic Ovary Syndrome?

Research shows that myo-inositol and D-chiro-inositol can improve ovarian function and metabolism in women with PCOS, with myo-inositol particularly effective in enhancing the metabolic profile and reducing symptoms like excess male hormones. A combination of these inositols in a 40:1 ratio has been found beneficial for improving metabolic, hormonal, and reproductive aspects of PCOS. ^{1 2 3 4 5}

Is inositol safe for use in humans?

Inositol, particularly in the forms of myo-inositol and D-chiro-inositol, has been shown to be safe in humans, with studies reporting no significant side effects when used for conditions like PCOS and type 2 diabetes. ^{1 2 3 6 7}

How does the treatment Inositol differ from other treatments for PCOS?

Inositol, particularly Myo-Inositol (MI), is unique in its ability to improve ovarian function and fertility in women with PCOS by enhancing insulin sensitivity and hormonal balance, which can lead to better ovulation and reduced symptoms like acne and excess hair growth. Unlike some other treatments, MI has shown significant benefits in improving metabolic and reproductive aspects of PCOS, and it is often used in a specific 40:1 ratio with D-chiro-inositol (DCI) for optimal results. ^{2 4 8 9 10}

Research Team

Richard S. Legro, M.D.

Principal Investigator

Penn State College of Medicine, Hershey Medical Center

Eligibility Criteria

This trial is for women with PCOS, who have high testosterone levels or irregular menstrual cycles. They should also show polycystic ovaries on an ultrasound. Women can't join if they have other hormonal disorders like Cushing's syndrome, are taking certain medications affecting ovarian function, or have a history of allergic reactions to inositol supplements.

Inclusion Criteria

Women with high levels of testosterone in their blood.

I have irregular periods, either very few a year or more than 45 days apart.

Women with high levels of testosterone in their blood.

Exclusion Criteria

I have a condition known as congenital adrenal hyperplasia due to an enzyme deficiency.

I am taking medications that could affect my ovarian function, like metformin or hormonal contraceptives.

My prolactin levels are high, measured twice, one week apart.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive inositol supplementation or placebo in a dose-ranging double-blind RCT over a three-month period

12 weeks

Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Inositol (Dietary Supplement)
• Placebo (Other)

Trial Overview The INSUPP-PCOS study is testing whether Inositol, a dietary supplement, can reduce excessive androgen levels in the ovaries and adrenal glands of women with Polycystic Ovary Syndrome (PCOS). Participants will either receive Inositol or a placebo.

Participant Groups

Group I: Active Treatment with Inositol 3 gm/bid Experimental Treatment 1 Intervention

Women with PCOS (N = 30) will receive daily inositol powder BID as active drug (each dose with 3000 mg of myo-inositol and 75 mg of d-chiro-inositol) over the initial 3 mos RCT period.

Group II: Active Treatment with Inositol 2 gm/bid Experimental Treatment 1 Intervention

Women with PCOS (N = 30) will receive daily inositol powder BID as active drug (each dose with 2000 mg of myo-inositol and 50 mg of d-chiro-inositol) over the initial 3 mos RCT period.

Group III: Active Treatment with Inositol 1gm/bid Experimental Treatment 1 Intervention

Women with PCOS (N = 30) will receive daily inositol powder BID as active drug (each dose with 1000 mg of myo-inositol and 25 mg of d-chiro-inositol) over the initial 3 mos RCT period.

Group IV: Placebo Treatment bid Placebo Group 1 Intervention

Women with PCOS (N = 30) will receive the daily placebo (maltodextrin and inulin) in an identical fashion as the active study group and will be monitored the same.

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

Dr. Robert Harbaugh

Milton S. Hershey Medical Center

Chief Medical Officer since 2024

MD from Penn State College of Medicine

Don McKenna

Milton S. Hershey Medical Center

Chief Executive Officer since 2024

Master’s in Public Administration and Bachelor of Science in Business Administration and Marketing from Long Island University

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Dr. Amy P. Patterson

National Center for Complementary and Integrative Health (NCCIH)

Chief Medical Officer

MD from Johns Hopkins University

Dr. Helene Langevin

National Center for Complementary and Integrative Health (NCCIH)

Chief Executive Officer since 2018

MD from McGill University

Findings from Research

In a study of 20 obese women with Polycystic Ovarian Syndrome (PCOS), a combined therapy of myo-inositol and D-chiro-inositol significantly improved lipid profiles, reducing LDL cholesterol and triglycerides while increasing HDL cholesterol after 6 months of treatment.

The therapy also led to significant improvements in insulin resistance, as measured by HOMA-IR, indicating that it may effectively reduce cardiovascular risk factors associated with PCOS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Combined therapy myo-inositol plus D-Chiro-inositol, in a physiological ratio, reduces the cardiovascular risk by improving the lipid profile in PCOS patients. Minozzi, M., Nordio, M., Pajalich, R.[2013]

References

1. England pubmed.ncbi.nlm.nih.gov

Comparison between effects of myo-inositol and D-chiro-inositol on ovarian function and metabolic factors in women with PCOS. [2014]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Inositols in PCOS. [2023]

3. Egypt pubmed.ncbi.nlm.nih.gov

Inositol Treatment for PCOS Should Be Science-Based and Not Arbitrary. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Myo-inositol effects in women with PCOS: a meta-analysis of randomized controlled trials. [2020]

5. Australia pubmed.ncbi.nlm.nih.gov

May myo-inositol and d-chiro-inositol (40:1) treatment be a good option on normal-weighted polycystic ovary syndrome patients without insulin resistance? [2021]

6. Egypt pubmed.ncbi.nlm.nih.gov

The Effectiveness of Myo-Inositol and D-Chiro Inositol Treatment in Type 2 Diabetes. [2022]

7. Italy pubmed.ncbi.nlm.nih.gov

The Combined therapy myo-inositol plus D-Chiro-inositol, in a physiological ratio, reduces the cardiovascular risk by improving the lipid profile in PCOS patients. [2013]

8. Italy pubmed.ncbi.nlm.nih.gov

Bye-bye chiro-inositol - myo-inositol: true progress in the treatment of polycystic ovary syndrome and ovulation induction. [2013]

9. England pubmed.ncbi.nlm.nih.gov

D-Chiro-inositol and PCOS: between myth and reality. The never-ending story. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Experts' opinion on inositols in treating polycystic ovary syndrome and non-insulin dependent diabetes mellitus: a further help for human reproduction and beyond. [2021]