Inositol Supplementation to Treat PCOS (INSUPP-PCOS)

Phase 2

Recruiting

• Conditions: Anovulation; Glucose Intolerance; Insulin Resistance; Metabolic Complication; Polycystic Ovary Syndrome; Hyperandrogenism
• Interventions: Other: Placebo; Drug: Inositol

• Registration Number: NCT03864068
• Lead Sponsor: Milton S. Hershey Medical Center

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 of three doses of inositol vs. placebo over a three month period with the reduction in hyperandrogenism (based on serum testosterone levels) as the primary outcome and key secondary outcomes of the change in sex hormone binding globulin(SHBG) and the related free androgen index, fasting insulin levels and area under the curve glucose levels from an oral glucose challenge test (OGTT). The hypothesis is that women with PCOS who receive inositol supplementation will have a dose related reduction in hyperandrogenism. Further, we propose that the primary mechanism of inositol will be a significant improvement in hyperandrogenism (both ovarian and adrenal) vs. placebo, as documented by a lower free androgen index \[decreased total testosterone and increased sex hormone blinding globulin (SHBG)\], lower sebum measures and lower antral follicle counts of the ovary and anti-Mullerian hormone, all of which will correlate with the decrease in hyperandrogenism.

Study Timeline

• Study First Submitted: 2019-03-04
• Study First Submitted QC: 2019-03-04
• Study First Posted: 2019-03-06
• Study Start: 2020-01-24
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 128

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Treatment bid	Placebo	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.
Active Treatment with Inositol 1gm/bid	Inositol	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.
Active Treatment with Inositol 3 gm/bid	Inositol	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.
Active Treatment with Inositol 2 gm/bid	Inositol	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.

Primary Outcome Measures

Name	Time	Method
Change in total testosterone	baseline and 3 months	Serum total testosterone levels

Secondary Outcome Measures

Name	Time	Method
Change in fasting insulin	baseline and 3 months	Fasting insulin levels
Change in SHBG	baseline and 3 months	SHBG levels
Change in Free Androgen Index (FAI)	baseline and 3 months	FAI levels
Change in area under the curve (AUC) of glucose	baseline and 3 months	AUC of a 2-hour 75g glucose tolerance test, which measures glucose at 0, 30, 60, 90, and 120 minutes.

Trial Locations

Locations (2)

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States