Inositol for Polycystic Ovary Syndrome

(INSUPP-PCOS Trial)

Recruiting at 1 trial location

Overseen By Anuja Dokras, MD, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2

Sponsor: Milton S. Hershey Medical Center

Must not be taking: Metformin, Hormonal contraceptives

Disqualifiers: Hyperprolactinemia, Cushing's syndrome, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

154 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Inositol, a dietary supplement, can reduce excess androgens, such as testosterone, in women with Polycystic Ovarian Syndrome (PCOS). Participants will receive either different doses of Inositol or a placebo to compare effects on symptoms. Women with infrequent or irregular periods who have been diagnosed with PCOS may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that inositol is generally safe for people. A review of studies found that inositol is effective and safe for women with Polycystic Ovary Syndrome (PCOS). Other studies support this, indicating that inositol remains safe during pregnancy and breastfeeding, demonstrating a strong safety record. Although individual reactions can vary, most reports mention only minor side effects. For those considering joining a trial, current evidence suggests that inositol is a safe choice. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about inositol for treating Polycystic Ovary Syndrome (PCOS) because it offers a potentially safer and more natural alternative to current medications like hormonal treatments and insulin sensitizers. Inositol, a naturally occurring compound, may help restore hormonal balance and improve insulin sensitivity in women with PCOS, addressing the root causes of the condition. Unlike traditional treatments that can have significant side effects, inositol is well-tolerated and could provide a gentler option for managing PCOS symptoms. Different doses are being tested to find the most effective amount, which could further personalize treatment plans for individuals.

What evidence suggests that this trial's treatments could be effective for PCOS?

Research has shown that inositol can benefit women with Polycystic Ovary Syndrome (PCOS) by improving overall health and reducing high levels of male hormones. Studies have found that inositol can enhance ovarian function, which is crucial for women with PCOS. In this trial, participants will receive different dosages of inositol—1 gram, 2 grams, and 3 grams daily—to evaluate its effectiveness. One study found that taking 2 grams of inositol daily was effective for this purpose. However, limited information exists on how inositol affects ovulation, pregnancy, and birth rates. While inositol appears promising, more research is needed to fully understand its benefits for PCOS. ^{3 5 6 7 8}

Who Is on the Research Team?

Richard S. Legro, M.D.

Principal Investigator

Penn State College of Medicine, Hershey Medical Center

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Inositol
• Placebo

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.

How Is the Trial Designed?

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.

Inositol is already approved in European Union, United States for the following indications:

Approved in European Union as Inositol for:

• Polycystic Ovary Syndrome (PCOS)

Approved in United States as Inositol for:

• Polycystic Ovary Syndrome (PCOS)

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

In a study of 50 women with polycystic ovary syndrome (PCOS), both myo-inositol and D-chiro-inositol were effective in improving ovarian function and metabolic health over six months.

Myo-inositol had a more significant positive impact on metabolic profiles, while D-chiro-inositol was more effective in reducing symptoms of hyperandrogenism, indicating that both forms of inositol can be beneficial but may serve different therapeutic roles.

NCBI (Pubmed)

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. Pizzo, A., Laganà, AS., Barbaro, L.[2014]

In a pilot study involving patients with type 2 diabetes (T2DM), a combination of myo-inositol and d-chiro-inositol taken for three months significantly reduced fasting blood glucose and HbA1c levels, indicating improved glycemic control.

The treatment was found to be safe, with no reported side effects, suggesting that inositol supplementation could be a beneficial add-on to existing glucose-lowering medications for T2DM patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Myo-Inositol and D-Chiro Inositol Treatment in Type 2 Diabetes. Pintaudi, B., Di Vieste, G., Bonomo, M.[2022]

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]

Inositol, particularly myo-inositol (MI), is an effective insulin sensitizer for treating polycystic ovary syndrome (PCOS), which affects about 10% of women of reproductive age.

Research indicates that MI improves oocyte and embryo quality more effectively than D-chiro-inositol (DCI), suggesting that MI may be the preferred choice in clinical gynecology and reproductive medicine for PCOS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bye-bye chiro-inositol - myo-inositol: true progress in the treatment of polycystic ovary syndrome and ovulation induction. Galletta, M., Grasso, S., Vaiarelli, A., et al.[2013]

In a study of 46 polycystic ovary syndrome (PCOS) patients without insulin resistance, treatment with myo-inositol and d-chiro-inositol (40:1) resulted in significantly higher ovulation rates in normal-weight patients (79.3%) compared to obese/overweight patients (29.4%).

The normal-weight group also had higher post-treatment progesterone levels and a much greater rate of spontaneous pregnancies (85.7%) compared to the obese/overweight group (33.3%), suggesting that MI:DCI treatment is particularly effective for normal-weight PCOS patients.

NCBI (Pubmed)

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? Colak, E., Ozcimen, EE., Tohma, YA., et al.[2021]

The analysis highlights that the combination of myo-inositol and D-chiro-inositol for treating Polycystic Ovary Syndrome (PCOS) must be carefully considered, as higher doses of D-chiro-inositol can negatively impact reproductive performance and IVF outcomes.

Clinical evidence supports a specific 40:1 ratio of myo-inositol to D-chiro-inositol as optimal for restoring ovulation in women with PCOS, yet many current inositol products lack this therapeutic rationale and may include ineffective or harmful ingredients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inositol Treatment for PCOS Should Be Science-Based and Not Arbitrary. Roseff, S., Montenegro, M.[2020]

Myoinositol (MI) treatment has been shown to improve ovarian function and fertility in patients with polycystic ovarian syndrome (PCOS), as well as reduce symptoms like acne and hirsutism, based on a review of 47 clinical trials.

The combination of MI and D-chiro-inositol (DCI) in a 40:1 ratio may enhance metabolic, hormonal, and reproductive outcomes in PCOS, indicating a promising therapeutic approach for managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inositols in PCOS. Kamenov, Z., Gateva, A.[2023]

Diet and lifestyle changes are essential for managing Polycystic Ovary Syndrome (PCOS), and they can help restore ovarian function in some patients, but medications or supplements may also be necessary.

Inositol therapy, particularly Myo-inositol and D-chiro-Inositol, has been shown to play a significant role in treating PCOS, with D-chiro-Inositol potentially acting as an ovarian aromatase inhibitor, which could help regulate hormone levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

D-Chiro-inositol and PCOS: between myth and reality. The never-ending story. Cianci, A., Vitale, SG.[2022]

Myo-Inositol (MI) and D-Chiro-Inositol (DCI) are important for treating Polycystic Ovary Syndrome (PCOS) and type 2 diabetes, with a 40:1 MI/DCI ratio showing promising efficacy in managing these conditions.

The use of MI, either alone or in combination with DCI, is considered safe and effective, but further research is needed to determine the optimal MI/DCI ratio for type 2 diabetes and its potential benefits in fertility treatments.

NCBI (Pubmed)

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. Facchinetti, F., Appetecchia, M., Aragona, C., et al.[2021]

Myo-inositol (MI) supplementation significantly reduces fasting insulin levels and improves metabolic profiles in women with polycystic ovary syndrome (PCOS), based on a meta-analysis of 9 randomized controlled trials involving 496 participants.

MI supplementation for at least 24 weeks leads to a significant increase in serum sex hormone-binding globulin (SHBG), which may help alleviate hyperandrogenism, although testosterone levels showed only a slight reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Myo-inositol effects in women with PCOS: a meta-analysis of randomized controlled trials. Unfer, V., Facchinetti, F., Orrù, B., et al.[2020]

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