Recruitment

Recruitment Status
Completed
Estimated Enrollment
80

Inclusion Criterias

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
Current height less than 5th percentile AND/OR

Exclusion Criterias

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 Criterias

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
Current height less than 5th percentile AND/OR

Exclusion Criterias

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