NCT03864068CompletedPhase 2
Inositol Supplementation to Treat PCOS (INSUPP-PCOS)
Inositol Supplementation to Treat Polycystic Ovary Syndrome: A Double Blind Dose Ranging RCT (INSUPP-PCOS)
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
To determine if Inositol, a dietary supplement, will improve ovarian and adrenal androgen excess in women with Polycystic Ovarian Syndrome(PCOS).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 154 (actual)
- First submitted
- 4 Mar 2019
- Start date
- 24 Jan 2020
- Primary completion date
- 10 Dec 2025
- Lead sponsor
- Milton S. Hershey Medical Center
- NCT number
- NCT03864068
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 154
- From 24 Jan 2020 to the primary completion date, 10 Dec 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Women with medical conditions that are contraindications to OTC inositol or previous allergic reactions to the supplement or to the placebo maltodextrin or inulin.
Other illness
- 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 Cushing's syndrome
- Women on confounding medications which affect ovarian function including metformin, hormonal contraceptives or other medications for type 2 diabetes
Other
- 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 a suspected adrenal or ovarian tumor secreting androgens
Who the study is looking for
- 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.
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Penn State College of Medicine, Penn State Milton S. Hershey Medical Center Coordinator of this site? Confirm its status | Hershey | United States | Unknown status |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.