Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01859312 · ClinicalTrials.gov registry record · Phase 2
Comparison of Cortisol Pump With Standard Treatment for Congenital Adrenal Hyperplasia
A Phase 2 study of Adrenal Insufficiency and Congenital Adrenal Hyperplasia (CAH), sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT01859312 is a Phase 2 study of Adrenal Insufficiency and Congenital Adrenal Hyperplasia (CAH) that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 8 participants, below the 3,065-participant average among 5 other Adrenal Insufficiency trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01859312, a Phase 2 study of Adrenal Insufficiency and Congenital Adrenal Hyperplasia (CAH), has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: * Congenital adrenal hyperplasia (CAH) is a genetic disorder of the adrenal gland. The adrenal gland is located in the abdomen and produces small amounts of hormones such as cortisol, aldosterone, and androgen. These hormones help control blood pressure, protect the body, and maintain good health, especially during development. People with CAH do not make enough cortisol and aldosterone, and make too much androgen. This can lead to serious medical problems. The standard treatment is to take pills that mimic the effects of cortisol and aldosterone. However, treatment with pills can have long-term side effects because of the higher doses needed, and may not work well for some people. * A possible new treatment for CAH is to use a pump to deliver cortisol under the skin. Similar pumps are often used to give insulin to people with diabetes. Researchers think that a cortisol pump might be able to help the body use the cortisol more effectively than taking pills. They want to compare the results of a cortisol pump and standard pill treatments for CAH. Objectives: \- To compare the effectiveness of a cortisol pump with standard cortisol pill therapy for CAH. Eligibility: \- Men and women at least 18 years of age who have CAH (see more details in Eligibility section below). Design: * This study will involve four inpatient hospital stays at the National Institutes of Health in Bethesda, MD over 6 months (spaced 2 months apart). The first and last stays will last about 5 days. The second and third stays will last about 3 days. * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. * At the first study visit, participants will provide regular blood and urine samples. They will also have imaging studies. These studies will look at the bones, fat, and muscles in the abdomen and pelvis. * Participants will receive a cortisol pump during the first visit. They will be shown how to use the pump. They wi
Conditions Studied
Interventions
- DRUG Hydrocortisone (Solucortef)
- DEVICE Insulin pump (Medtronic)
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2013-05-06 |
| Est. Completion | 2016-12-02 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01859312
The ClinicalTrials.gov registry entry for NCT01859312 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,065-participant average among 5 other Adrenal Insufficiency trials with a reported enrollment target (100% lower). The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Adrenal Insufficiency appearing as the primary indexed condition, and to 2 interventions - of which Hydrocortisone (Solucortef) is the first listed.
NCT01859312 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT01859312 about?
NCT01859312 is a clinical study titled "Comparison of Cortisol Pump With Standard Treatment for Congenital Adrenal Hyperplasia". Background: * Congenital adrenal hyperplasia (CAH) is a genetic disorder of the adrenal gland. The adrenal gland is located in the abdomen and produces small amounts of hormones such as cortisol, aldosterone, and androgen. These hormones help control blood pressure, protect the body, and maintain g...
What is the current status of trial NCT01859312?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2013-05-06. Estimated completion is 2016-12-02.
What conditions does trial NCT01859312 study?
This clinical trial studies the following conditions: Adrenal Insufficiency, Congenital Adrenal Hyperplasia (CAH), Excess Androgen.
What interventions are being tested in trial NCT01859312?
The interventions under investigation include: Hydrocortisone (Solucortef) (DRUG), Insulin pump (Medtronic) (DEVICE).
Who is sponsoring clinical trial NCT01859312?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01859312 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Adrenal Insufficiency
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Block-and-Replace Therapy With Osilodrostat and Concomitant Glucocorticoid Replacement
RECRUITING
-
Evaluation of Children With Endocrine and Metabolic-Related Conditions
RECRUITING
-
Updated Diagnostic Cortisol Values for Adrenal Insufficiency
RECRUITING · NA
-
Cortisol Response to Moderate and Deep Sedation in Children
COMPLETED
-
Defining the Mechanisms Underlying Adrenal Insufficiency in Cirrhosis
COMPLETED
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.