Status:
COMPLETED
Inositol Supplementation to Treat PCOS (INSUPP-PCOS)
Lead Sponsor:
Milton S. Hershey Medical Center
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Polycystic Ovary Syndrome
Anovulation
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2025
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT03864068
Start Date
January 24 2020
End Date
December 10 2025
Last Update
January 7 2026
Active Locations (2)
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1
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
2
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104