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.
- Signature on Informed Consent form.
- 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.)
- 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.)
- Screening Exam and Physical - each element of the exam must be completed within one year prior
to enrollment in study.
- Examination Schedule:
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)
- Statistical analysis of data and results at each visit, with results discussed with the patient,
and decisions made with regard to continuing treatment options.
- Publication of results in compliance with good medical standards of practice.