Status:
COMPLETED
Treatment of Boys With Precocious Puberty
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Precocious Puberty
Eligibility:
MALE
Phase:
PHASE2
Brief Summary
This study is a continuation of two previous studies conducted at the NIH. The first study , "Treatment of True Precocious Puberty with a Long-Acting Lutenizing Hormone Releasing Hormone Analog (D-Trp...
Detailed Description
Most males with precocious puberty who have been referred to NIH have been successfully treated under protocol 79-CH-0112 "Treatment of True Precocious Puberty with a Long-Acting Luteinizing Hormone R...
Eligibility Criteria
INCLUSION CRITERIA:
Patients with familial male precocious puberty will be admitted to the Clinical Center.
In order to be eligible for the study, the following criteria will be met:
Boys 10 years of age or less.
Tanner II to IV pubertal development.
Unfused epiphyses by bone films.
Evidence that precocious puberty is not secondary to another recognized cause of pseudopuberty:
- We will exclude congenital adrenal hyperplasia, and document pretreatment androgen levels, by a 1-hour ACTH test, which will include measurement of 11-deoxycortisol and 17-OH-progesterone at 0 and 60 minutes.
- We will exclude tumor of adrenal or testes by physical exam, ultrasound, and measurement of adrenal androgens (DHA, DHAS, androstenedione).
Elevated testosterone levels measured at 10 am, 2pm, 10 pm and 2 am over a 24 hour period.
Key Trial Info
Start Date :
January 1 1985
Trial Type :
INTERVENTIONAL
End Date :
January 1 2004
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00001202
Start Date
January 1 1985
End Date
January 1 2004
Last Update
March 4 2008
Active Locations (1)
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1
National Institute of Child Health and Human Development (NICHD)
Bethesda, Maryland, United States, 20892