Using Inositol to Improve Symptoms of PCOS
Inositol Supplementation to Treat Polycystic Ovary Syndrome: A Double Blind Dose Ranging RCT (INSUPP-PCOS)
This study tests if taking inositol can help women with PCOS feel better by lowering their testosterone levels and improving other related symptoms.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Milton S. Hershey Medical Center Academic / other |
| Locations | 2 sites (Hershey, Pennsylvania and 1 other locations) |
| Trial ID | NCT03864068 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effects of inositol supplementation on women with Polycystic Ovary Syndrome (PCOS), focusing on its potential to reduce hyperandrogenism. It is a double-blind, randomized controlled trial with four arms, comparing three different doses of inositol against a placebo over a three-month period. The primary outcome is the reduction in serum testosterone levels, while secondary outcomes include changes in sex hormone binding globulin, fasting insulin levels, and glucose tolerance. The hypothesis is that inositol will lead to a dose-dependent decrease in hyperandrogenism symptoms.
Who should consider this trial
Good fit: Ideal candidates for this study are women diagnosed with PCOS who experience chronic anovulation or oligomenorrhea and exhibit signs of hyperandrogenism.
Not a fit: Patients with conditions such as hyperprolactinemia, congenital adrenal hyperplasia, or uncorrected thyroid disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-invasive option for managing symptoms of PCOS, particularly hyperandrogenism.
How similar studies have performed: Previous studies have shown promising results with inositol supplementation in managing PCOS symptoms, indicating that this approach has potential based on existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Hyperandrogenism defined as a total testosterone greater than 50 ng/dL or a free androgen index greater than 10. * 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. Exclusion Criteria: * Women with Hyperprolactinemia defined as 2 prolactin levels at least one week apart greater than 30 ng/mL. * Women with known 21-hydroxylase deficiency or other enzyme deficiency leading to the congenital adrenal hyperplasia. * Women with elevated FSH levels greater than 10 mIU/mL. * Women with uncorrected thyroid disease as per ASRM guidelines for nonpregnant subjects (TSH less than 0.45 mIU/mL or greater than 4.5 MIU/mL). * Women with a suspected adrenal or ovarian tumor secreting androgens * Women with Cushing's syndrome * Women on confounding medications which affect ovarian function including metformin, hormonal contraceptives or other medications for type 2 diabetes * Women with medical conditions that are contraindications to OTC inositol or previous allergic reactions to the supplement or to the placebo maltodextrin or inulin.
Where this trial is running
Hershey, Pennsylvania and 1 other locations
- Penn State College of Medicine, Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Richard S. Legro, M.D. — Penn State College of Medicine, Hershey Medical Center
- Study coordinator: Amyee McMonagle, BSN
- Email: amcmonagle@pennstatehealth.psu.edu
- Phone: 717-531-4484
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.