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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 3 months
Awards & highlights

INSUPP-PCOS Trial Summary

This trial is testing whether Inositol, a dietary supplement, can help improve ovarian and adrenal androgen excess in women with Polycystic Ovarian Syndrome (PCOS).

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.Check my eligibility
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.See study design
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.

INSUPP-PCOS Trial Eligibility Criteria

Inclusion Criteria

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

INSUPP-PCOS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in total testosterone
Secondary outcome measures
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

INSUPP-PCOS 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
491 Previous Clinical Trials
2,798,677 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
829 Previous Clinical Trials
668,801 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would elderly citizens be interested in participating in this clinical research?

"The age qualifications for this particular clinical trial are that applicants must be between 18-45 years old. There are 441 other studies for patients who fall below the age of majority and 1220 for senior citizens."

Answered by AI

Are there any dangers associated with Inositol?

"Inositol's safety is estimated to be a 2 because, while there is data attesting to its safety, there is no available evidence that it is an effective medication."

Answered by AI

To whom is this research project available?

"This study is looking for 128 women of childbearing age who have anovulation issues. The most important criteria that candidates must meet are as follows: having polycystic ovaries (as shown on ultrasound), chronic anovulation or oligomenorrhea, and hyperandrogenism."

Answered by AI

What other research exists on Inositol's medical benefits?

"At this time, there are seven ongoing clinical trials researching inositol with one of them being in Phase 3. Most of the research is taking place in Boston, although there are investigations happening at seven different locations."

Answered by AI

Are people still being signed up for this experiment?

"The search for eligible participants is ongoing, as this clinical trial has not yet reached its quota. The study was first publicized on 1/24/2020 and updated as recently as 10/3/2022 according to the information available on clinicaltrials.gov"

Answered by AI

Who else is applying?

What state do they live in?
Michigan
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
University of Pennsylvania
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

What questions have other patients asked about this trial?

Would this trial cover costs of research related imaging and medication, or am I responsible for certain fees? When would this study start, and do I have any flexibility regarding preferred days of the week for in person visits?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Penn State College of Medicine, Penn State Milton S. Hershey Medical Center: < 48 hours
Average response time
  • < 2 Days
~12 spots leftby Aug 2024