128 Participants Needed

Inositol for Polycystic Ovary Syndrome

(INSUPP-PCOS Trial)

Recruiting at 1 trial location
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AM
AD
Overseen ByAnuja Dokras, MD, PhD
Age: 18 - 65
Sex: Female
Trial Phase: Phase 2
Sponsor: Milton S. Hershey Medical Center
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

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.12345

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.36789

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.134910

Who Is on the Research Team?

RS

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.
See 3 more

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.
See 5 more

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?
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Active Treatment with Inositol 3 gm/bidExperimental Treatment1 Intervention
Group II: Active Treatment with Inositol 2 gm/bidExperimental Treatment1 Intervention
Group III: Active Treatment with Inositol 1gm/bidExperimental Treatment1 Intervention
Group IV: Placebo Treatment bidPlacebo Group1 Intervention

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

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Approved in European Union as Inositol for:
🇺🇸
Approved in United States as Inositol for:

Find a Clinic Near You

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.
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]
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.
Inositols in PCOS.Kamenov, Z., Gateva, A.[2023]
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.
Inositol Treatment for PCOS Should Be Science-Based and Not Arbitrary.Roseff, S., Montenegro, M.[2020]

Citations

Comparison between effects of myo-inositol and D-chiro-inositol on ovarian function and metabolic factors in women with PCOS. [2014]
Inositols in PCOS. [2023]
Inositol Treatment for PCOS Should Be Science-Based and Not Arbitrary. [2020]
Myo-inositol effects in women with PCOS: a meta-analysis of randomized controlled trials. [2020]
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]
The Effectiveness of Myo-Inositol and D-Chiro Inositol Treatment in Type 2 Diabetes. [2022]
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]
Bye-bye chiro-inositol - myo-inositol: true progress in the treatment of polycystic ovary syndrome and ovulation induction. [2013]
D-Chiro-inositol and PCOS: between myth and reality. The never-ending story. [2022]
Experts' opinion on inositols in treating polycystic ovary syndrome and non-insulin dependent diabetes mellitus: a further help for human reproduction and beyond. [2021]
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