Inositol Supplementation to Treat PCOS (INSUPP-PCOS)

Last updated: December 3, 2024
Sponsor: Milton S. Hershey Medical Center
Overall Status: Active - Recruiting

Phase

2

Condition

Diabetes Prevention

Female Hormonal Deficiencies/abnormalities

Infertility

Treatment

Placebo

Inositol

Clinical Study ID

NCT03864068
Study00010252
1R01AT009484-01A1
  • Ages 18-45
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women with chronic anovulation or oligomenorrhea defined as spontaneousintermenstrual periods of greater than or equal to 45 days or a total of less thanor equal to 8 menses per year.

  • Women with Hyperandrogenism defined as a total testosterone greater than 50 ng/dL ora free androgen index greater than 10.

  • Women with Polycystic Ovaries on Ultrasound defined as either 12 or more folliclesmeasuring 2-9 mm in diameter or increased ovarian volume greater than 10 cm.

Exclusion

Exclusion Criteria:

  • Women with Hyperprolactinemia defined as 2 prolactin levels at least one week apartgreater than 30 ng/mL.

  • Women with known 21-hydroxylase deficiency or other enzyme deficiency leading to thecongenital adrenal hyperplasia.

  • Women with elevated FSH levels greater than 10 mIU/mL.

  • Women with uncorrected thyroid disease as per ASRM guidelines for nonpregnantsubjects (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 previousallergic reactions to the supplement or to the placebo maltodextrin or inulin.

Study Design

Total Participants: 128
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
January 24, 2020
Estimated Completion Date:
November 30, 2025

Study 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.

Connect with a study center

  • Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

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