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Inositol Supplementation to Treat PCOS (INSUPP-PCOS)

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Conditions

Polycystic Ovary SyndromeAnovulationHyperandrogenismInsulin ResistanceGlucose IntoleranceMetabolic Complication

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Inositol Supplementation to Treat Polycystic Ovary Syndrome: A Double Blind Dose Ranging RCT (INSUPP-PCOS)

Quick Facts

Study Start:2020-01-24
Study Completion:2025-12-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT03864068

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Women with Hyperandrogenism defined as a total testosterone greater than 50 ng/dL or a free androgen index greater than 10.
  3. * 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.
  1. * Women with Hyperprolactinemia defined as 2 prolactin levels at least one week apart greater than 30 ng/mL.
  2. * Women with known 21-hydroxylase deficiency or other enzyme deficiency leading to the congenital adrenal hyperplasia.
  3. * Women with elevated FSH levels greater than 10 mIU/mL.
  4. * 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).
  5. * Women with a suspected adrenal or ovarian tumor secreting androgens
  6. * Women with Cushing's syndrome
  7. * Women on confounding medications which affect ovarian function including metformin, hormonal contraceptives or other medications for type 2 diabetes
  8. * Women with medical conditions that are contraindications to OTC inositol or previous allergic reactions to the supplement or to the placebo maltodextrin or inulin.

Contacts and Locations

Principal Investigator

Richard S. Legro, M.D.
PRINCIPAL_INVESTIGATOR
Penn State College of Medicine, Hershey Medical Center

Study Locations (Sites)

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Milton S. Hershey Medical Center

  • Richard S. Legro, M.D., PRINCIPAL_INVESTIGATOR, Penn State College of Medicine, Hershey Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-24
Study Completion Date2025-12-10

Study Record Updates

Study Start Date2020-01-24
Study Completion Date2025-12-10

Terms related to this study

Keywords Provided by Researchers

  • Polycystic Ovary Syndrome
  • Anovulation
  • Hyperandrogenism
  • Insulin Resistance
  • Glucose Intolerance
  • Metabolic Complication

Additional Relevant MeSH Terms

  • Polycystic Ovary Syndrome
  • Anovulation
  • Hyperandrogenism
  • Insulin Resistance
  • Glucose Intolerance
  • Metabolic Complication