Inositol Supplementation to Treat PCOS (INSUPP-PCOS)

Description

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

Conditions

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

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Study Overview

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Study Details

Study overview

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

Inositol Supplementation to Treat Polycystic Ovary Syndrome: A Double Blind Dose Ranging RCT (INSUPP-PCOS)

Inositol Supplementation to Treat PCOS (INSUPP-PCOS)

Condition
Polycystic Ovary Syndrome
Intervention / Treatment

-

Contacts and Locations

Hershey

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States, 17033

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 45 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Milton S. Hershey Medical Center,

Richard S. Legro, M.D., PRINCIPAL_INVESTIGATOR, Penn State College of Medicine, Hershey Medical Center

Study Record Dates

2025-11-30