Inositol Supplementation to Treat PCOS (INSUPP-PCOS)

NCT03864068 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: Study000102521R01AT009484-01A1
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 2

Brief Summary

To determine if Inositol, a dietary supplement, will improve ovarian and adrenal androgen excess in women with Polycystic Ovarian Syndrome(PCOS).

Conditions

Insulin Resistance; Glucose Intolerance; Metabolic Complication; Polycystic Ovary Syndrome; Anovulation; Hyperandrogenism

Keywords

Polycystic Ovary Syndrome; Anovulation; Hyperandrogenism; Insulin Resistance; Glucose Intolerance; Metabolic Complication

Outcome Measures

Primary Outcomes (1)

• Change in total testosterone

  Serum total testosterone levels

  baseline and 3 months

Secondary Outcomes (4)

• Change in SHBG

  baseline and 3 months

• Change in Free Androgen Index (FAI)

  baseline and 3 months

• Change in area under the curve (AUC) of glucose

  baseline and 3 months

• Change in fasting insulin

  baseline and 3 months

Study Arms (4)

Placebo Treatment bid

PLACEBO COMPARATOR

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.

Other: Placebo

Active Treatment with Inositol 1gm/bid

EXPERIMENTAL

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.

Drug: Inositol

Active Treatment with Inositol 2 gm/bid

EXPERIMENTAL

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.

Drug: Inositol

Active Treatment with Inositol 3 gm/bid

EXPERIMENTAL

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.

Drug: Inositol

Interventions

Placebo OTHER

Placebo

Also known as: maltodextrin and inulin

Placebo Treatment bid

Inositol DRUG

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

Active Treatment with Inositol 1gm/bid; Active Treatment with Inositol 2 gm/bid; Active Treatment with Inositol 3 gm/bid

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: PCOS is a disorder that only affects women and therefore men are not eligible to participate in this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (2)

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

Hershey, Pennsylvania, 17033, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Anovulation; Hyperandrogenism; Insulin Resistance; Glucose Intolerance

Interventions

maltodextrin; Inulin; Inositol

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; 46, XX Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Adrenogenital Syndrome; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperglycemia

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides; Sugar Alcohols; Alcohols; Organic Chemicals

Study Officials

• Richard S. Legro, M.D.

  Penn State College of Medicine, Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Obstetrics and Gynecology

Model Details: Placebo Group; Active Treatment with Inositol 1gm/bid; Active Treatment with Inositol 2gm/bid; Active Treatment with Inositol 3gm/ bid

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 6, 2019
• Study Start: January 24, 2020
• Primary Completion: December 10, 2025
• Study Completion: December 10, 2025
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

US (2)