Comparison of a Needle-free Injection Method With a Needle-syringe Injection Method

Inclusion Criteria:

• Subjects must require a routine Tev-Tropin® dose that does not exceed 2.5 mg in oneinjection (0.5 mL) using the dosing schedule individualized for each patient by theirprescribing physician

• Male, age 7-17 years, with the capability to provide assent, as determined by theinvestigator and/or parent or legal guardian

• Clinically definite growth hormone deficiency as previously diagnosed by theinvestigator or other physician

• Subjects must be using Tev-Tropin® prior to enrollment for 28 days

• Informed consent signed by parent(s) or legal custodian of patient prior to studyentry and patient assent as determined by the investigator and/or subject's parent orlegal custodian

Exclusion Criteria:

• More than one subcutaneous injection per Tev-Tropin® dose

• Female gender

• Use of any other needle-free injection device at any time

• Current use of another human growth hormone product other than Tev-Tropin®

• Concurrent treatment with other routine injectable medications

• History of benign intracranial hypertension

• Significant communication difficulties, or medical or psychiatric condition, thataffects the subject's and/or caregiver's ability to perform the necessary functions tocomplete the study, or any condition which the investigator in their medical judgmentthinks may interfere with participation in the study

• Use of an investigational drug within 30 days prior to randomization

• Contraindications related to routine use of Tev-Tropin® as per investigators' medicaljudgment (e.g., subjects with closed epiphyses, active proliferative or severenon-proliferative diabetic retinopathy, active malignancy, acute critical illness, orPrader-Willi syndrome who are severely obese or have severe respiratory impairment)

• Current participation in another pharmaceutical or device study

• Previous participation in this study