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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of randomization assessed up to 20 weeks.

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor

1,379 Previous Clinical Trials

1,588,485 Total Patients Enrolled

Kyriaki Sarafoglou, MDPrincipal InvestigatorUniversity of Minnesota

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age restriction for this trial extend below thirty years old?

"This trial only accepts individuals aged between 4 and 18 years old. There are 344 studies dedicated to younger patients, while 843 explore the effects of medication on those over 65."

Answered by AI

Are there vacancies in this research project for individuals to participate?

"Currently, this trial is not enrolling new participants. The study was initially published on January 1st 2019 and last updated on August 1st 2022. However, if you are interested in other studies related to adrenal hyperplasia or congenital subcutaneous hydrocortisone there are 1198 and 60 respective trials actively recruiting patients at present."

Answered by AI

Approximately how many subjects are being observed in this experiment?

"The recruitment phase for this medical trial has concluded, as the last update was made on August 1st 2022. However, there are 1198 clinical trials presently searching for participants with adrenal hyperplasia, congenital and 60 studies actively looking to recruit patients who have Subcutaneous hydrocortisone."

Answered by AI

What other investigations have been undertaken concerning the use of Subcutaneous hydrocortisone?

"Currently, hydrocortisone has 60 ongoing studies; of these experiments, 20 are in their final Phase. 3054 sites across the USA are working with this medication and New york City holds the most trials for Subcutaneous hydrocortisone."

Answered by AI

What are the eligibility requirements to join this experiment?

"8 minors aged between 4 and 18, who have been diagnosed with congenital adrenal hyperplasia, are needed to enroll in this clinical trial. Further criteria includes: patients being of the aforementioned age range."

Answered by AI

What potential complications can arise from the usage of Subcutaneous hydrocortisone?

"Subcutaneous hydrocortisone's safety is tentatively assessed with a score 1 since this is the first phase of testing, which means there are still limited data supporting its effectiveness and security."

Answered by AI

What indications warrant the administration of subcutaneous hydrocortisone?

"Subcutaneous hydrocortisone is a viable medical option for the treatment of ulcerative colitis and other health conditions such as malignant neoplasms, varicella-zoster virus acute retinal necrosis, and crohn disease."

Answered by AI

Recent research and studies

Current Opinion in Endocrinology, Diabetes & ObesityJournal

Adrenal Insufficiency Updates in Children

Ramirez Alcantara, Jonanlis, and Alyssa Halper. 2020. “Adrenal Insufficiency Updates in Children”. Current Opinion in Endocrinology, Diabetes & Obesity. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/med.0000000000000591.

clinicaltrials.govStudy

Subcutaneous Hydrocortisone Children With Congenital Adrenal Hyperplasia

2019. "Subcutaneous Hydrocortisone Children With Congenital Adrenal Hyperplasia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03718234.