Inositol Supplementation to Treat PCOS (INSUPP-PCOS)
Polycystic Ovary Syndrome · Anovulation · Hyperandrogenism · Insulin Resistance · Glucose Intolerance · Metabolic Complication
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Phase 2
- Age range
- 18 years - 45 years
- Sex eligible
- Female
- Healthy volunteers
- Not accepted
- Participants
- 99 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
To determine if Inositol, a dietary supplement, will improve ovarian and adrenal androgen excess in women with Polycystic Ovarian Syndrome(PCOS).
Read the full 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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.
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- Quadruple masked
Placebo Treatment bid
Women with PCOS will receive the daily placebo (maltodextrin and inulin) in an identical fashion as the active study group and will be monitored the same.
Other: Placebo
Active Treatment with Inositol 1gm/bid
Women with PCOS 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.
Drug: Inositol
Active Treatment with Inositol 2 gm/bid
Women with PCOS will receive daily inositol powder BID as active drug (each dose with 2000 mg of myo-inositol and 50 mg of d-chiro-inositol) over the initial 3 mos RCT period.
Drug: Inositol
Active Treatment with Inositol 3 gm/bid
Women with PCOS will receive daily inositol powder BID as active drug (each dose with 3000 mg of myo-inositol and 75 mg of d-chiro-inositol) over the initial 3 mos RCT period.
Drug: Inositol
Placebo OTHER
Placebo
Inositol DRUG
1gm/bid, 2gm/bid or 3gm/bid of Inositol powder
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Total Testosterone
Time frame: 3 months (baseline, 1 month and 3 month visits)
Total testosterone levels measured at baseline, 1 month, and 3 month visits.
Secondary measures
SHBG
Time frame: 3 months (baseline, 1 month and 3 month visits)
Sex hormone-binding globulin (SHBG) levels measured at baseline, 1 month, and 3 month visits.
Free Androgen Index (FAI)
Time frame: 3 months (baseline, 1 month and 3 month visits)
Free Androgen Index calculated at baseline, 1 month, and 3 month visits. FAI is calculated as (testosterone/SHBG)\*100 (after converting testosterone to the same units as SHBG)
Area Under the Curve (AUC) of Glucose
Time frame: 3 months (baseline and 3 month visits)
AUC of a 2-hour 75g glucose tolerance test, which measures glucose at 0, 30, 60, 90, and 120 minutes. AUC was calculated at baseline and 3 month visit.
Fasting Insulin
Time frame: 3 months (baseline and 3 month visits)
Fasting insulin levels measured at baseline and 3 month visit.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (2)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
2 locations
Penn State College of Medicine, Penn State Milton S. Hershey Medical CenterHershey, Pennsylvania, United StatesStatus unknown
University of PennsylvaniaPhiladelphia, Pennsylvania, United StatesStatus unknown
Study team and timeline
- Lead sponsor
- Milton S. Hershey Medical Center
- Study start
- Jan 24, 2020 Actual
- Primary completion
- Dec 10, 2025 Actual
- Study completion
- Dec 10, 2025 Actual
- First posted
- Mar 6, 2019 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Inositol Supplementation to Treat Polycystic Ovary Syndrome: A Double Blind Dose Ranging RCT (INSUPP-PCOS)
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026