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Corticosteroid

Triple-Drug Therapy for Congenital Adrenal Hyperplasia

Phase 4
Waitlist Available
Led By Deborah P Merke, M.D.
Research Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects will be boys with bone ages 2 to 13 years and girls with bone ages 2 to 11 years with classic 21-hydroxylase
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at study conclusion and analysis
Awards & highlights

Study Summary

This trial is testing a new four-drug combination to see if it can normalize growth in children with congenital adrenal hyperplasia. The children will be followed until they reach their final adult height to see if the new combination is effective.

Who is the study for?
This trial is for children with Congenital Adrenal Hyperplasia who haven't started puberty or are suppressing it. Boys aged 2-13 and girls aged 2-11, based on bone age, can join. Kids needing steroids for other illnesses or those not stabilized on standard treatments cannot participate.Check my eligibility
What is being tested?
The study compares a new four-drug combo (flutamide, testolactone, reduced hydrocortisone dose, fludrocortisone) to the usual care in kids with Congenital Adrenal Hyperplasia. It aims to see if growth normalizes using these drugs until they reach adult height.See study design
What are the potential side effects?
Possible side effects include hormonal imbalances due to Fludrocortisone and Hydrocortisone; Letrozole may cause bone pain or hot flashes; Flutamide might lead to liver issues or gastrointestinal discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a boy aged 2-13 or a girl aged 2-11 with classic 21-hydroxylase deficiency.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at study conclusion and analysis
This trial's timeline: 3 weeks for screening, Varies for treatment, and at study conclusion and analysis for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adult height
Secondary outcome measures
Growth velocity (SD units)
Predicted adult height (Bayley-Pinneau)
Weight velocity (SD units)
+1 more

Side effects data

From 2011 Phase 4 trial • 115 Patients • NCT00611923
38%
headache
31%
stomach pain
23%
dry skin
15%
insomnia
15%
hot flushes
15%
nausea
15%
Diarrhea
8%
fatigue
8%
dry mouth
8%
leg pain
8%
parasthesia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Flutamide

Trial Design

2Treatment groups
Experimental Treatment
Group I: Investigational 2Experimental Treatment3 Interventions
girls/flutamide, letrozole, and reduced hydrocortisone dose, the Letrozole will discontinue at 13 y.o. and continue flutamide until 2 years after menarche or when final height is reached, whichever occurs first
Group II: Investigational 1Experimental Treatment4 Interventions
boys/flutamide, letrozole, and reduced hydrocortisone dose or conventional treatment (with hydrocortisone and fludrocortisone ) until the age of 14
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludrocortisone
2016
Completed Phase 4
~440
Hydrocortisone
2005
Completed Phase 4
~1280
Letrozole
2002
Completed Phase 4
~2770
Flutamide
2013
Completed Phase 4
~1980

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Lead Sponsor
1,978 Previous Clinical Trials
2,680,291 Total Patients Enrolled
Deborah P Merke, M.D.Principal InvestigatorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
2 Previous Clinical Trials
3,008 Total Patients Enrolled

Media Library

Fludrocortisone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT00001521 — Phase 4
Congenital Adrenal Hyperplasia Research Study Groups: Investigational 2, Investigational 1
Congenital Adrenal Hyperplasia Clinical Trial 2023: Fludrocortisone Highlights & Side Effects. Trial Name: NCT00001521 — Phase 4
Fludrocortisone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00001521 — Phase 4
~2 spots leftby Jun 2025
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