Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT00689260
Eligibility Criteria:
Inclusion Criteria:
* Be male or female from 10 to 18 years of age, inclusive, with open epiphyses
* Have GH deficiency diagnosed by treating pediatric endocrinologist for at least 6 months
* Be undergoing rhGH treatment via self-injection using the Lilly Humatrope® or Pfizer Genotropin® pen injection device for at least 6 months
* Be willing and able to comply with the protocol for the duration of the trial
* Have access to the Internet
* Be able to read, speak and understand English
* If female of childbearing potential, have a negative urine pregnancy test at Screening and use an acceptable form of birth control during the trial, including abstinence, a hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with spermicide
Exclusion Criteria:
* Known allergy or hypersensitivity to rhGH or prescribed diluent (0.3% metacresol for click.easy® cartridge)
* Severe illness during the previous 6 months
* Active malignancy (except non-melanomatous skin malignancies)
* Diabetes mellitus (type I or II)
* Pregnancy or lactation
* Any medical condition that, in the opinion of the Investigator, would jeopardize the subject's safety following exposure to the investigational device
* Participation in any other investigational study during the duration of participation in this trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
18 Years
Study:
NCT00689260
Study Brief:
Protocol Section:
NCT00689260