Inositol Supplementation to Treat PCOS (INSUPP-PCOS) (INSUPP-PCOS)
Inositol Supplementation to Treat Polycystic Ovary Syndrome: A Double Blind Dose Ranging RCT (INSUPP-PCOS)
Sponsor: Milton S. Hershey Medical Center
Listed as NCT03864068, this PHASE2 trial focuses on Anovulation and Glucose Intolerance and remains completed. Sponsored by Milton S. Hershey Medical Center, it has been updated 23 times since 2020, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)This trial will test prospectively the effects of inositol supplementation in a dose ranging double blind randomized controlled trial, according to CONSORT guidelines. This will be a four armed study of three doses of inositol vs. placebo over a three month period with the reduction in hyperandrogenism (based on serum testosterone levels) as the primary outcome and key secondary outcomes of the change in sex hormone binding globulin(SHBG) and the related free androgen index, fasting insulin levels and area under the curve glucose levels from an oral glucose challenge test (OGTT). The hypothesis is that women with PCOS who receive inositol supplementation will have a dose related reduction in hyperandrogenism. Further, we propose that the primary mechanism of inositol will be a significant improvement in hyperandrogenism (both ovarian and adrenal) vs. placebo, as documented by a lower free androgen index \[decreased total testosterone and increased sex hormone blinding globulin (SHBG)\], lower sebum measures and lower antral follicle counts of the ovary and anti-Mullerian hormone, all of which will correlate with the decrease in hyperandrogenism.
This trial will test prospectively the effects of inositol supplementation in a dose ranging double blind randomized controlled trial, according to CONSORT guidelines. This will be a four armed study of three doses of inositol vs. placebo over a three month period with the reduction in hyperandrogenism (based on serum testosterone levels) as the primary outcome and key secondary outcomes of the change in sex hormone binding globulin(SHBG) and the related free androgen index, fasting insulin levels and area under the curve glucose levels from an oral glucose challenge test (OGTT). The hypothesis is that women with PCOS who receive inositol supplementation will have a dose related reduction in hyperandrogenism. Further, we propose that the primary mechanism of inositol will be a significant improvement in hyperandrogenism (both ovarian and adrenal) vs. placebo, as documented by a lower free androgen index \[decreased total testosterone and increased sex hormone blinding globulin (SHBG)\], lower sebum measures and lower antral follicle counts of the ovary and anti-Mullerian hormone, all of which will correlate with the decrease in hyperandrogenism.
Status Flow
Change History
23 versions recorded-
Feb 2026 — Present [monthly]
Completed PHASE2
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Feb 2026 — Present [monthly]
Completed PHASE2
Status: Recruiting → Completed
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Jan 2026 — Feb 2026 [monthly]
Recruiting PHASE2
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Jan 2026 — Present [monthly]
Recruiting PHASE2
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Jan 2025 — Jan 2026 [monthly]
Recruiting PHASE2
▶ Show 18 earlier versions
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Sep 2024 — Jan 2025 [monthly]
Recruiting PHASE2
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Jul 2024 — Sep 2024 [monthly]
Recruiting PHASE2
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Mar 2024 — Jul 2024 [monthly]
Recruiting PHASE2
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Nov 2023 — Mar 2024 [monthly]
Recruiting PHASE2
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Nov 2022 — Nov 2023 [monthly]
Recruiting PHASE2
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Sep 2022 — Nov 2022 [monthly]
Recruiting PHASE2
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Sep 2021 — Sep 2022 [monthly]
Recruiting PHASE2
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Jan 2021 — Sep 2021 [monthly]
Recruiting PHASE2
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Jul 2020 — Jan 2021 [monthly]
Recruiting PHASE2
Status: Active Not Recruiting → Recruiting
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May 2020 — Jul 2020 [monthly]
Active Not Recruiting PHASE2
Status: Recruiting → Active Not Recruiting
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Mar 2020 — May 2020 [monthly]
Recruiting PHASE2
Status: Not Yet Recruiting → Recruiting
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Feb 2020 — Mar 2020 [monthly]
Not Yet Recruiting PHASE2
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Dec 2019 — Feb 2020 [monthly]
Not Yet Recruiting PHASE2
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Nov 2019 — Dec 2019 [monthly]
Not Yet Recruiting PHASE2
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Oct 2019 — Nov 2019 [monthly]
Not Yet Recruiting PHASE2
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Aug 2019 — Oct 2019 [monthly]
Not Yet Recruiting PHASE2
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Jun 2019 — Aug 2019 [monthly]
Not Yet Recruiting PHASE2
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Apr 2019 — Jun 2019 [monthly]
Not Yet Recruiting PHASE2
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- Milton S. Hershey Medical Center
- National Center for Complementary and Integrative Health (NCCIH)
For direct contact, visit the study record on ClinicalTrials.gov .