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Search / Trial NCT00001202

Treatment of Boys With Precocious Puberty

Launched by EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT (NICHD) · Nov 3, 1999

Trial Information

Current as of March 23, 2025

Completed

Keywords

Luteinizing Hormone High Serum Testosterone Levels Low Baseline Gonadotropin Lhrh Precocious Puberty Familial Isosexual Precocious Puberty

ClinConnect Summary

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 Releasing Hormone Analog (D-Trp6-Pro9-Net-LHRH)." A subset of these patients, however, all of whom had familial male isosexual precocity, had an inadequate response to LHRH analog as demonstrated by high serum testosterone levels, rapid advancement in bone age, testicular growth, sperm production, and lack of regression of secondary sex characteristics. These patients had low baseline gonadotrop...

Gender

MALE

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:
  • 1. 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.
  • 2. 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.

About Eunice Kennedy Shriver National Institute Of Child Health And Human Development (Nichd)

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is a prominent research agency within the National Institutes of Health (NIH), dedicated to advancing the health and well-being of children, families, and individuals across the lifespan. NICHD supports a wide range of clinical trials and research initiatives aimed at understanding the complex biological, behavioral, and environmental factors that influence human development and health. By fostering innovative research and facilitating collaboration among scientists, healthcare professionals, and communities, NICHD plays a vital role in translating scientific discoveries into effective interventions and policies that enhance child health, reproductive health, and the prevention of diseases.

Locations

Bethesda, Maryland, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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