Inositol for Polycystic Ovary Syndrome
(INSUPP-PCOS Trial)
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?
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive inositol supplementation or placebo in a dose-ranging double-blind RCT over a three-month period
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Inositol
- Placebo
Inositol is already approved in European Union, United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Milton S. Hershey Medical Center
Lead Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator