# Inositol Supplementation to Treat Reproductive and Metabolic Dysfunction in Polycystic Ovary Syndrome: A Double Blind RCT (INSUPP-PCOS)

> **NIH NIH R01** · PENNSYLVANIA STATE UNIV HERSHEY MED CTR · 2024 · $403,288

## Abstract

PROJECT SUMMARY ABSTRACT
Polycystic ovary syndrome (PCOS) is the most common endocrinopathy among women. It is a heterogeneous
syndrome with reproductive dysfunction of chronic anovulation and hyperandrogenism, as well as metabolic
dysfunction: insulin resistance, glucose intolerance and metabolic syndrome. One such medication that may
improve both aspects of PCOS is inositol and it is available throughout the world as a dietary supplement.
More specifically we will study a combination of isomers, d-chiro and myo-inositol. The combination is thought
to improve insulin (and gonadotropin) signaling by restoring an imbalance in inositolglycans which are second
messengers in cell surface signaling. This project is the first adequately powered and designed double-blind
randomized clinical trial to test prospectively the effects of inositol supplementation in a double blind study (the
INSUPP PCOS study). We are conducting a four-armed study of inositol: Inositol at 1 gm, 2 gm, 3 gm bid vs.
placebo bid over a 3 month period in 108 women with PCOS. The purpose of this supplement is for us to
complete the total enrollment count of 108 women. We want to successfully complete this project in order to
reach our study goals and specific aims, which remain the same. Identify the effect of inositol supplementation
on serum testosterone levels during the study. Hypothesis 1 (Primary Outcome): Women with PCOS who
receive inositol supplementation will have a significantly greater reduction in serum total testosterone than
women on placebo, as well as our secondary markers of hyperandrogenism: SHBG and the free androgen
index.

## Key facts

- **NIH application ID:** 11167238
- **Project number:** 3R01AT009484-04S1
- **Recipient organization:** PENNSYLVANIA STATE UNIV HERSHEY MED CTR
- **Principal Investigator:** RICHARD S. LEGRO
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $403,288
- **Award type:** 3
- **Project period:** 2018-09-01 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11167238

## Citation

> US National Institutes of Health, RePORTER application 11167238, Inositol Supplementation to Treat Reproductive and Metabolic Dysfunction in Polycystic Ovary Syndrome: A Double Blind RCT (INSUPP-PCOS) (3R01AT009484-04S1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/11167238. Licensed CC0.

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