Status:
COMPLETED
Constitutional Delay of Growth and Puberty: Towards Evidence-based Treatment
Lead Sponsor:
Helsinki University Central Hospital
Collaborating Sponsors:
Foundation for Paediatric Research, Finland
Conditions:
Constitutional Delay of Growth and Puberty
Eligibility:
MALE
14-17 years
Phase:
PHASE2
PHASE3
Brief Summary
Boys with constitutional delay of growth and puberty (CDGP) should be offered evidence-based effective and safe treatment option. This study compares the effects of low-dose testosterone and aromatase...
Eligibility Criteria
Inclusion
- Constitutional delay of growth and puberty
- Age 14 years or more
- mean testicular volume 2.5 ml or more and less than 4 ml
- serum testosterone level less than 5 nM OR
- as above, but serum testosterone 1 nM or more with normal DHEAS level, even if the mean testicular volume is less than 2.5 ml OR
- as above, but tanner stage G2 and testosterone level less than 3 nM
Exclusion
- Chronic diseases
- Primary or secondary hypogonadism
- Chromosomal anomalies
- Chronic medication that potentially adversely affects bone mineralization (excluding inhaled corticosteroid treatment)
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 5 2018
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01797718
Start Date
October 1 2013
End Date
February 5 2018
Last Update
February 6 2018
Active Locations (4)
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1
Helsinki University Central Hospital
Helsinki, Finland, 00029
2
Kotka Central Hospital
Kotka, Finland
3
Kuopio University Central Hospital
Kuopio, Finland, 70211
4
Turku University Central Hospital
Turku, Finland, 20521