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Dietary Supplement

Inositol for Polycystic Ovary Syndrome (INSUPP-PCOS Trial)

Phase 2

Recruiting

Led By Richard S. Legro, M.D.

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women with chronic anovulation or oligomenorrhea defined as spontaneous intermenstrual periods of greater than or equal to 45 days or a total of less than or equal to 8 menses per year

Women with Polycystic Ovaries on Ultrasound defined as either 12 or more follicles measuring 2-9 mm in diameter or increased ovarian volume greater than 10 cm

Must not have

Women with known 21-hydroxylase deficiency or other enzyme deficiency leading to the congenital adrenal hyperplasia

Women with Hyperprolactinemia defined as 2 prolactin levels at least one week apart greater than 30 ng/mL

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 3 months

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Inositol is generally considered safe but may cause mild side effects such as nausea, tiredness, headache, dizziness. Since it's a dietary supplement being tested against a placebo which has no active ingredients, severe side effects are not commonly expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Select...

My ultrasound shows I have polycystic ovaries.

Select...

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

Select...

My ultrasound shows I have polycystic ovaries.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

Select...

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

Select...

My FSH hormone level is above 10 mIU/mL.

Select...

I may have a tumor in my adrenal gland or ovary that is producing male hormones.

Select...

I am a woman diagnosed with Cushing's syndrome.

Select...

I am allergic to inositol, maltodextrin, or inulin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in total testosterone

Secondary study objectives

Change in Free Androgen Index (FAI)

Change in SHBG

Change in area under the curve (AUC) of glucose

+1 more

Side effects data

From 2019 Phase 4 trial • 69 Patients • NCT01396486

14%

Nausea/Vomit/Diarrhea

Increased Appetite

Cold/Infection/Allergy

Insomnia

Pulmonary

Earache

Thirsty

Neurological

Headache

Tics

Musculoskeletal

Autonomic

Dizzy/Lightheaded

Agitated with Homicidal Statements

100%

80%

60%

40%

20%

Study treatment Arm

Omega-3/Placebo

Omega-3/Inositol

Placebo/Inositol

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Active Treatment with Inositol 3 gm/bidExperimental Treatment1 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/bidExperimental Treatment1 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/bidExperimental Treatment1 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 bidPlacebo Group1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Inositol

2012

Completed Phase 4

~140

0 / 10Eligibility criteria met