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Triple-Drug Therapy for Congenital Adrenal Hyperplasia
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2011 Phase 4 trial • 115 Patients • NCT00611923Trial Design
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Who is running the clinical trial?
Media Library
- My child's bone age is between 1 and 2 years, and we're seeking optimized therapy.My child needs steroids for another illness or takes medication that affects steroid use.I am a boy aged 2-13 or a girl aged 2-11 with classic 21-hydroxylase deficiency.I have not started puberty or I am taking medication to manage early puberty.
- Group 1: Investigational 1
- Group 2: Investigational 2
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Could you please share what other research studies have used Flutamide?
"As of now, 245 clinical trials are underway to study flutamide. 74 of those studies are in Phase 3. Torrance, California is homebase for many of these investigations, however there are 17760 total locations running related research."
For what sorts of treatments is Flutamide usually prescribed?
"Flutamide has been shown to be an effective medical intervention for patients struggling with ulcerative colitis, malignant neoplasms, and varicella-zoster virus acute retinal necrosis."
How many research subjects are included in this investigation?
"This research project is no longer recruiting patients. The study was created on 6/8/1995 and last updated 11/1/2022. Currently, there are 245 clinical trials for Flutamide admitting patients and 145 trials for adrenal hyperplasia, congenital that are actively looking for participants."
Are volunteers still being sought for this research project?
"This research project, as specified on clinicaltrials.gov, is not looking for participants at this time. The date the trial was originally posted was 6/8/1995 and the last update to the posting was on 11/1/2022. There are other 390 trials that are open for enrollment currently."
Do the elderly qualify for this particular experiment?
"Eligible participants for this clinical trial must be between 2 and 18 years old."
How does Flutamide impact patients' safety?
"Flutamide is a medication that has gone through Phase 2 clinical trials, meaning there is some data to support its safety. However, as it has not yet reached Phase 3, there is no evidence affirming its efficacy."
How can I sign up to be a part of this research?
"This study is looking for 62 participants who currently have adrenal hyperplasia, congenital. In order to be eligible, subjects must meet the following criteria: Children with a bone age of 1 to 2 years may enroll in the protocol for optimization of conventional therapy, but will not be randomized to a study arm until the bone age reaches 2., Subjects will be boys with bone ages 2 to 13 years and girls with bone ages 2 to 11 years with classic 21-hydroxylase., Subjects must either not yet have undergone pubertal activation of the hypothalamic-pituitary-gonadal axis, or, if pu"
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