An Investigational Study

Study Screening and Examinations

      The following is a breakdown of the examination required prior to starting the program and at progressively scheduled intervals. This is to insure the correct combination of hormones are added to the rGH injection, and to insure the patients safety. It is also necessary for management of the study to monitor each patients progress and provide empirical results. The study continues three years depending on the patients progress.

      In conjunction with the examination, a pre-consent agreement is required to comply with the Institutional Review Boards (IRB) requirements prior to starting the study.

Examination Requirements
  1. Signature on Informed Consent form.
  2. Screening - Extensive physical and health exam: chest X-rays, EKG, complete blood chemistry, hormone evaluation, cancer screening, personal medical history and training on the administration and storage of rGH. This sets the necessary baseline measurements for managing and documenting physical and mental improvements over the course of the study. (Actual details will be explained at acceptance into the study.)
  3. Body Composition Analysis and Performance Physical: Similar to the above, but focused on measurable physical and mental performance designed to document improvements over the course of the study. (Specific tests and parameters explained at acceptance into the study.)

Examination Schedule
  1. Screening Exam and Physical - each element of the exam must be completed within one year prior to enrollment in study.
  2. Examination Schedule:
  3. Visit 1: Screening Exam (Year 1)
    Visit 2: 3 months
    Visit 3: 6 months
    Visit 4: 9 months
    Visit 5: 12 months (Year 2)
    Visit 6: 18 months
    Visit 7: 24 months
    Visit 8: 30 months
    Visit 9: 36 months (Year 3)

Study Conclusion
  1. Statistical analysis of data and results at each visit, with results discussed with the patient, and decisions made with regard to continuing treatment options.
  2. Publication of results in compliance with good medical standards of practice.