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NCT03864068 | RECRUITING | Polycystic Ovary Syndrome

Inositol Supplementation to Treat PCOS (INSUPP-PCOS)
Sponsor:

Milton S. Hershey Medical Center

Information provided by (Responsible Party):

Richard S. Legro, M.D.

Brief Summary:

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

Condition or disease

Polycystic Ovary Syndrome

Anovulazation

Hyperandrogenism

Insulin Resistance

Glucose Intolerance

Metabolic Complication

Intervention/treatment

Placebo

Inositol

Phase

PHASE2

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 Type : INTERVENTIONAL
Estimated Enrollment : 128 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : Inositol Supplementation to Treat Polycystic Ovary Syndrome: A Double Blind Dose Ranging RCT (INSUPP-PCOS)
Actual Study Start Date : 2020-01-24
Estimated Primary Completion Date : 2025-11-30
Estimated Study Completion Date : 2025-11-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 45 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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.
Inositol Supplementation to Treat PCOS (INSUPP-PCOS)

Location Details

NCT03864068

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Locations

RECRUITING

United States, Pennsylvania

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

Hershey, Pennsylvania, United States, 17033

RECRUITING

United States, Pennsylvania

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104