Inositol Supplementation to Treat PCOS (INSUPP-PCOS)

NCT ID: NCT03864068

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-24
• Study Completion Date: 2025-12-10

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo Treatment bid

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo

Active Treatment with Inositol 1gm/bid

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.

Group Type: EXPERIMENTAL

Inositol

Intervention Type: DRUG

1gm/bid, 2gm/bid or 3gm/bid of Inositol powder

Active Treatment with Inositol 2 gm/bid

Women with PCOS (N = 30) 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.

Group Type: EXPERIMENTAL

Inositol

Intervention Type: DRUG

1gm/bid, 2gm/bid or 3gm/bid of Inositol powder

Active Treatment with Inositol 3 gm/bid

Women with PCOS (N = 30) 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.

Group Type: EXPERIMENTAL

Inositol

Intervention Type: DRUG

1gm/bid, 2gm/bid or 3gm/bid of Inositol powder

Interventions

Placebo

Placebo

Intervention Type: OTHER

Inositol

1gm/bid, 2gm/bid or 3gm/bid of Inositol powder

Intervention Type: DRUG

Other Intervention Names

maltodextrin and inulin

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Richard S. Legro, M.D.

Chair, Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard S. Legro, M.D.

Role: PRINCIPAL_INVESTIGATOR

Penn State College of Medicine, Hershey Medical Center

Locations

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

1R01AT009484-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Study00010252

Identifier Type: -

Identifier Source: org_study_id