Clinical trial · Interventional
Inositol Supplementation to Treat PCOS (INSUPP-PCOS)
Inositol Supplementation to Treat Polycystic Ovary Syndrome: A Double Blind Dose Ranging RCT (INSUPP-PCOS)
NCT03864068CI-TRIAL-00100295INSUPP-PCOScompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To determine if Inositol, a dietary supplement, will improve ovarian and adrenal androgen excess in women with Polycystic Ovarian Syndrome(PCOS).
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anovulation | — | UNRESOLVED | — |
| Glucose Intolerance | — | UNRESOLVED | — |
| Hyperandrogenism | — | UNRESOLVED | — |
| Insulin Resistance | — | UNRESOLVED | — |
| Metabolic Complication | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Inositol | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- PLACEBO_COMPARATOR
- label
- Placebo Treatment bid
- description
- Women with PCOS (N = 30) will receive the daily placebo (maltodextrin and inulin) in an identical fashion as the active study group and will be monitored the same.
- interventionNames
- Other: Placebo
- type
- EXPERIMENTAL
- label
- Active Treatment with Inositol 1gm/bid
- description
- Women with PCOS (N = 30) will receive daily inositol powder BID as active drug (each dose with 1000 mg of myo-inositol and 25 mg of d-chiro-inositol) over the initial 3 mos RCT period.
- interventionNames
- Drug: Inositol
- type
- EXPERIMENTAL
- label
- Active Treatment with Inositol 2 gm/bid
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.