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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
Awards & highlights

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:
Select...
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 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
5%
Increased Appetite
5%
Cold/Infection/Allergy
5%
Insomnia
5%
Pulmonary
5%
Earache
5%
Thirsty
5%
Neurological
5%
Headache
5%
Tics
5%
Musculoskeletal
5%
Autonomic
5%
Dizzy/Lightheaded
5%
Agitated with Homicidal Statements
100%
80%
60%
40%
20%
0%
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

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor
504 Previous Clinical Trials
2,795,812 Total Patients Enrolled
5 Trials studying Polycystic Ovary Syndrome
473 Patients Enrolled for Polycystic Ovary Syndrome
National Center for Complementary and Integrative Health (NCCIH)NIH
846 Previous Clinical Trials
672,797 Total Patients Enrolled
3 Trials studying Polycystic Ovary Syndrome
248 Patients Enrolled for Polycystic Ovary Syndrome
Richard S. Legro, M.D.Principal Investigator - Penn State College of Medicine, Hershey Medical Center
Penn State Geisinger Rehabilitation Center, Penn State Milton S. Hershey Medical Center
Mt Sinai School Of Medical Of The City University Of New York (Medical School)
University Of Pittsburgh Medical Center (Residency)

Media Library

Inositol (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT03864068 — Phase 2
Polycystic Ovary Syndrome Research Study Groups: Placebo Treatment bid, Active Treatment with Inositol 1gm/bid, Active Treatment with Inositol 2 gm/bid, Active Treatment with Inositol 3 gm/bid
Polycystic Ovary Syndrome Clinical Trial 2023: Inositol Highlights & Side Effects. Trial Name: NCT03864068 — Phase 2
Inositol (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03864068 — Phase 2
~23 spots leftby Sep 2025
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