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Corticosteroid

Subcutaneous hydrocortisone for Congenital Adrenal Hyperplasia

Phase 1
Waitlist Available
Led By Kyriaki Sarafoglou, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization assessed up to 20 weeks.
Awards & highlights

Study Summary

This trial is testing whether a subcutaneous hydrocortisone pump is more effective than oral hydrocortisone therapy in children with congenital adrenal hyperplasia.

Eligible Conditions
  • Congenital Adrenal Hyperplasia
  • Cushing's Syndrome
  • Hydrocortisone
  • Steroid Metabolic Diseases
  • Adrenal Hyperplasia
  • Hyperplasia
  • Congenital Disorders
  • Intersex Conditions
  • Urogenital Abnormalities
  • Genetic Disorders
  • Adrenal Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization assessed up to 20 weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization assessed up to 20 weeks. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Duration of hypocortisolemia and hypercortisolemia will be significantly shorter
Serum concentrations will be within an acceptable range

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Subcutaneous Hydrocortisone via Infusion PumpExperimental Treatment1 Intervention
Patients will receive a subcutaneous injection of hydrocortisone (HC). Each patient's total daily dose (TDD) of oral tablet hydrocortisone to determine the doses to be delivered of the study drug. The 24-hr schedule and percentage of the TDD of HC will be as follows: approximately 60% of the TDD of HC will be delivered in 3 equal pulses at 0300, 0600 and 0900. Another 35% will be delivered in 3 equal pulses at 1200, 1500 and 1800 and the remaining 5% at 2100 and 2400.
Group II: Standard glucocorticoid therapyActive Control1 Intervention
Subjects in this arm will continue on standard oral hydrocortisone therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydrocortisone
FDA approved

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,388 Previous Clinical Trials
1,552,816 Total Patients Enrolled
Kyriaki Sarafoglou, MDPrincipal InvestigatorUniversity of Minnesota
~2 spots leftby Jun 2025
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