Inositol Supplementation to Treat PCOS (INSUPP-PCOS)

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Milton S. Hershey Medical Center
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)
• Treatments: Inositol

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.