Status:
COMPLETED
Follicle-Stimulating Hormone (FSH) and the Onset of Puberty
Lead Sponsor:
University of Utah
Collaborating Sponsors:
University of Michigan
University of Chicago
Conditions:
Delayed Puberty
Precocious Puberty
Eligibility:
All Genders
6-17 years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this study is to determine if the timing of the onset of puberty may be affected by FSH-regulatory peptides. We will determine how these peptides relate to FSH production in prepuberta...
Detailed Description
Girls begin puberty earlier and have as much as a 5-fold increase in incidence of precocious puberty as do boys, while boys are more likely to have delayed adolescence compared to girls. The reasons ...
Eligibility Criteria
Inclusion
- Early Puberty Children who have early puberty may participate in this study. Children must be between 6 and 10 years of age and be healthy with the exception of having early puberty. For early puberty, girls should have had the onset of breast development prior to 8 years of age and boys should have the onset of pubic hair growth or genital growth prior to 9 years of age.
- Inclusion Criteria for Delayed Puberty Children who have late (delayed) puberty may participate in this study. Children must be between 12 and 17 years of age and be healthy with the exception of having late puberty. In order to have late puberty, boys and girls should have short stature compared to their family with at least one year delay in bone age as determined by bone age x-ray and/or have the onset of secondary sexual characteristics (breast and pubic hair growth) at 12 years of age or later for a girl or 13 years of age or later for a boy.
Exclusion
- Early Puberty Children with known genetic disorders, chronic medical conditions requiring the use of steroids, and use of medication for puberty within the last 3 months are excluded.
- Delayed Puberty Children with known genetic disorders with the exception of possible hypogonadotropic hypogonadism, chronic medical conditions requiring the use of steroids, and use of medication for puberty within the last 3 months are excluded.
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Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00734279
Start Date
March 1 2006
End Date
December 1 2010
Last Update
December 26 2017
Active Locations (1)
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1
Utah Diabetes Center
Salt Lake City, Utah, United States, 84108