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NCT00250159 · ClinicalTrials.gov registry record
Natural History Study of Patients With Excess Androgen
A clinical trial of Congenital Adrenal Hyperplasia (CAH) and Familial Male-Limited Precocious Puberty (FMPP), sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Recruiting
- Registry status
- 3,000
- Enrollment target
- 2
- Study locations
NCT00250159: Recruiting study of Congenital Adrenal Hyperplasia (CAH) and Familial Male-Limited Precocious Puberty (FMPP), sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
NCT00250159 is a study of Congenital Adrenal Hyperplasia (CAH) and Familial Male-Limited Precocious Puberty (FMPP) that is actively recruiting participants, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 3,000 participants. The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00250159, a study of Congenital Adrenal Hyperplasia (CAH) and Familial Male-Limited Precocious Puberty (FMPP), is actively recruiting participants, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- RECRUITING
- Registry status
- 3,000 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study will evaluate and gather information in patients with genetic causes of too much androgen (male-like hormone) in order to better understand the effects of too much androgen and describe problems associated with it. Too much androgen in childhood, if untreated, results in rapid growth and early puberty with early cessation of growth and short stature in adulthood. Too much androgen in adulthood may result in infertility, and women may have excess facial hair, acne and a more male-like appearance. Excess androgen may also affect mood and behavior and possibly the secretion of other hormones, such as insulin. Two genetic diseases that result in early childhood androgen excess are congenital adrenal hyperplasia (CAH) and familial male-limited precocious puberty (FMPP). Patients with known or suspected CAH due to 21-hydroxylase deficiency, 11- hydroxylase deficiency, or 3-beta-hydroxysteroid dehydrogenase deficiency and males with known or suspected FMPP may be eligible for this study. Patients with both classic and non-classic CAH are eligible, and patients with androgen excess of unknown cause may be eligible. Participants undergo the following procedures: * Medical history and physical examination. * Fasting blood tests for analysis of hormones, blood chemistries including blood sugar and cardiovascular risk factors such as lipids. * Oral glucose tolerance test for patients with elevated insulin levels. For this test, a catheter (plastic tube) is placed in a vein in the patient's arm. The patient drinks a sugar-containing fluid and blood samples are collected through the catheter at intervals starting with drinking the solution, and then 30, 60 and 120 minutes after drinking the solution. * 24-hour urine collection to measure hormone levels in the urine. * DNA testing for patients with 21-hydroxylase deficiency to help identify the type of genetic mutation responsible for the disease. * X-ray of the left hand to measure bone age in growing children. The
Primary Outcome
Better understanding of CAH and FMPP
Conditions Studied
Study Locations (2)
District of Columbia
- Medstar Washington Hospital Center - Washington D.C.
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,000 participants |
| Start Date | 2006-01-02 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
What NCT00250159 shows while recruiting
NCT00250159 is an observational study that tracks outcomes without assigning an intervention. Its 3,000 participants enrollment target places it among the larger protocols in the corpus.
The record links to 2 conditions, with Congenital Adrenal Hyperplasia (CAH) appearing as the primary indexed condition, and to 0 interventions.
NCT00250159 reports a single indexed study location in District of Columbia, Maryland.
Frequently Asked Questions
What is clinical trial NCT00250159 about?
NCT00250159 is a clinical study titled "Natural History Study of Patients With Excess Androgen". This study will evaluate and gather information in patients with genetic causes of too much androgen (male-like hormone) in order to better understand the effects of too much androgen and describe problems associated with it. Too much androgen in childhood, if untreated, results in rapid growth and ...
What is the current status of trial NCT00250159?
This trial is currently recruiting. The enrollment target is 3,000 participants. The study started on 2006-01-02.
What conditions does trial NCT00250159 study?
This clinical trial studies the following conditions: Congenital Adrenal Hyperplasia (CAH), Familial Male-Limited Precocious Puberty (FMPP).
Who is sponsoring clinical trial NCT00250159?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00250159 being conducted?
This trial has 2 study locations across District of Columbia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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