Trials / Completed
CompletedNCT03864068
Inositol Supplementation to Treat PCOS (INSUPP-PCOS)
Inositol Supplementation to Treat Polycystic Ovary Syndrome: A Double Blind Dose Ranging RCT (INSUPP-PCOS)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 154 (actual)
- Sponsor
- Milton S. Hershey Medical Center · Academic / Other
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
To determine if Inositol, a dietary supplement, will improve ovarian and adrenal androgen excess in women with Polycystic Ovarian Syndrome(PCOS).
Detailed description
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.
Conditions
- Polycystic Ovary Syndrome
- Anovulation
- Hyperandrogenism
- Insulin Resistance
- Glucose Intolerance
- Metabolic Complication
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Placebo | Placebo |
| DRUG | Inositol | 1gm/bid, 2gm/bid or 3gm/bid of Inositol powder |
Timeline
- Start date
- 2020-01-24
- Primary completion
- 2025-12-10
- Completion
- 2025-12-10
- First posted
- 2019-03-06
- Last updated
- 2026-01-07
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03864068. Inclusion in this directory is not an endorsement.