Recruitment

Recruitment Status
Completed
Estimated Enrollment
80

Inclusion Criteria

Current height less than 5th percentile AND/OR
Predicted adult height (based on bone age) more than 10 cm below target height (mid parental height)
Evidence of puberty: physical signs and serum luteinizing hormone > 0.3 IU/L and testosterone > 15 ng/dl
Current height less than 5th percentile AND/OR
Predicted adult height (based on bone age) more than 10 cm below target height (mid parental height)
Evidence of puberty: physical signs and serum luteinizing hormone > 0.3 IU/L and testosterone > 15 ng/dl

Exclusion Criteria

Bone age reading more than 14.0 years
Follicle stimulating hormone > 20 IU/L
Bone age reading more than 14.0 years
Follicle stimulating hormone > 20 IU/L

Summary

Conditions
Short Stature
Type
Interventional
Phase
Phase 4
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 10 years and 17 years
Gender
Only males

Inclusion Criteria

Current height less than 5th percentile AND/OR
Predicted adult height (based on bone age) more than 10 cm below target height (mid parental height)
Evidence of puberty: physical signs and serum luteinizing hormone > 0.3 IU/L and testosterone > 15 ng/dl
Current height less than 5th percentile AND/OR
Predicted adult height (based on bone age) more than 10 cm below target height (mid parental height)
Evidence of puberty: physical signs and serum luteinizing hormone > 0.3 IU/L and testosterone > 15 ng/dl

Exclusion Criteria

Bone age reading more than 14.0 years
Follicle stimulating hormone > 20 IU/L
Bone age reading more than 14.0 years
Follicle stimulating hormone > 20 IU/L

Locations

Palo Alto, California, 94301
Palo Alto, California, 94301

Tracking Information

NCT #
NCT02137538
Collaborators
Not Provided
Investigators
  • Principal Investigator: E Kirk Neely, MD Stanford University
  • E Kirk Neely, MD Stanford University Principal Investigator: Laura K Bachrach, MD Stanford University Principal Investigator: Walter A Zegarra, MD Stanford University