Delayed Puberty in Boys; Clinical and Biochemical Characteristics and Effect of Testosterone Treatment
1 other identifier
observational
451
1 country
1
Brief Summary
To evaluate the phenotype and biochemical characteristics of boys referred for delayed puberty, to describe the frequency of associated co-morbidities and diseases, to evaluate the diagnostic criteria and the effect of testosterone treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 1990
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 1990
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 9, 2014
CompletedFirst Posted
Study publicly available on registry
January 13, 2014
CompletedJanuary 13, 2014
January 1, 2014
23.1 years
January 9, 2014
January 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Age at diagnosis in boys with delayed puberty.
We will evaluate the mean age at diagnosis as well as the age distribution of newly diagnosed boys. These data are compared to age at onset and progression of normal puberty in contemporary healthy Danish boys.
At first evaluation
Secondary Outcomes (1)
Selected secondary outcomes include clinical, auxological and biochemical parameters and association to specific genetic polymorphisms
At first evaluation and during first 12 months of observation / treatment
Study Arms (1)
Boys with delayed puberty
Boys with no signs of puberty by an age that is -2 standard deviation below the population mean.
Interventions
Eligibility Criteria
The study population consisted of boys who were referred to be evaluated for delayed puberty at the Department of Growth and Reproduction between January 1990 and February 2013.
You may qualify if:
- All boys identified in the period from January 1990 to February 2013
You may not qualify if:
- Misclassified (other diagnoses)
- Insufficient data
- Lost to follow up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Growth and Reproduction, Rigshospitalet
Copenhagen, 2100, Denmark
Related Publications (1)
Lawaetz JG, Hagen CP, Mieritz MG, Blomberg Jensen M, Petersen JH, Juul A. Evaluation of 451 Danish boys with delayed puberty: diagnostic use of a new puberty nomogram and effects of oral testosterone therapy. J Clin Endocrinol Metab. 2015 Apr;100(4):1376-85. doi: 10.1210/jc.2014-3631. Epub 2015 Jan 16.
PMID: 25594861DERIVED
Biospecimen
serum and white cells
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anders Juul, PhD, DMSc
Rigshospitalet, Denmark
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD, DMSc
Study Record Dates
First Submitted
January 9, 2014
First Posted
January 13, 2014
Study Start
January 1, 1990
Primary Completion
February 1, 2013
Study Completion
October 1, 2013
Last Updated
January 13, 2014
Record last verified: 2014-01