Status:
COMPLETED
Testolactone for the Treatment of Girls With LHRH Resistant Precocious Puberty
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Polyostotic Fibrous Dysplasia
Precocious Puberty
Eligibility:
FEMALE
Phase:
PHASE2
Brief Summary
The normal changes of puberty, such as breast enlargement, pubic hair and menstrual periods, usually begin between the ages of 9 and 15 in response to hormones produced in the body. Some children's bo...
Detailed Description
Females with precocious puberty who have low levels of serum gonadotropins and high levels of serum estrogen, or those who have demonstrated an inadequate clinical response to therapy with the luteini...
Eligibility Criteria
INCLUSION CRITERIA:
Patients are girls aged 1-8 years (on entry to the study) with gonadotropin-independent precocious puberty. All ethnic groups are included.
EXCLUSION CRITERIA:
Males are excluded, as are patients with clinically-significant hepatic and/or renal impairment (testolactone is metabolized via the liver and kidneys).
Key Trial Info
Start Date :
October 1 1982
Trial Type :
INTERVENTIONAL
End Date :
May 1 2003
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00001181
Start Date
October 1 1982
End Date
May 1 2003
Last Update
March 4 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institute of Child Health and Human Development (NICHD)
Bethesda, Maryland, United States, 20892