Inositol for Polycystic Ovary Syndrome

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center, Hershey, PA
Polycystic Ovary Syndrome+5 More ConditionsInositol - Drug
Eligibility
18 - 45
Female
What conditions do you have?
Select

Study 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).

Eligible Conditions
  • Polycystic Ovary Syndrome
  • Excess Androgen Syndrome
  • Anovulation
  • Metabolic Syndrome
  • Diabetes
  • Insulin Resistance

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: baseline and 3 months

baseline and 3 months
Change in Free Androgen Index (FAI)
Change in SHBG
Change in area under the curve (AUC) of glucose
Change in fasting insulin
Change in total testosterone

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Side Effects for

Omega-3/Inositol
14%Nausea/Vomit/Diarrhea
5%Insomnia
5%Pulmonary
5%Thirsty
5%Neurological
5%Headache
5%Tics
5%Cold/Infection/Allergy
5%Musculoskeletal
5%Earache
5%Autonomic
5%Increased Appetite
5%Dizzy/Lightheaded
5%Agitated with Homicidal Statements
This histogram enumerates side effects from a completed 2019 Phase 4 trial (NCT01396486) in the Omega-3/Inositol ARM group. Side effects include: Nausea/Vomit/Diarrhea with 14%, Insomnia with 5%, Pulmonary with 5%, Thirsty with 5%, Neurological with 5%.

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

4 Treatment Groups

Active Treatment with Inositol 3 gm/bid
1 of 4
Active Treatment with Inositol 2 gm/bid
1 of 4
Active Treatment with Inositol 1gm/bid
1 of 4
Placebo Treatment bid
1 of 4

Experimental Treatment

Non-Treatment Group

128 Total Participants · 4 Treatment Groups

Primary Treatment: Inositol · Has Placebo Group · Phase 2

Active Treatment with Inositol 3 gm/bid
Drug
Experimental Group · 1 Intervention: Inositol · Intervention Types: Drug
Active Treatment with Inositol 2 gm/bid
Drug
Experimental Group · 1 Intervention: Inositol · Intervention Types: Drug
Active Treatment with Inositol 1gm/bid
Drug
Experimental Group · 1 Intervention: Inositol · Intervention Types: Drug
Placebo Treatment bid
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inositol
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and 3 months

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor
469 Previous Clinical Trials
2,785,631 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
796 Previous Clinical Trials
657,484 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)

Eligibility Criteria

Age 18 - 45 · Female Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
Michigan50.0%
Pennsylvania50.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria50.0%
Met criteria50.0%

How responsive is this trial?

Typically responds via
Phone Call100.0%
Most responsive sites:
  1. Penn State College of Medicine, Penn State Milton S. Hershey Medical Center: < 48 hours
Average response time
  • < 2 Days

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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" - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.