Assessment | Information visit and inclusion criteria | Screening and randomization visit | Phone call 6 weeks | Visit 13 weeks | Final visit 26 weeks |
---|---|---|---|---|---|
 | V1 | V2 |  | V3 | V4 |
Check in & exclusion criteria | X | X | Â | Â | Â |
Informed consent | X | Â | Â | Â | Â |
Medical history (/update) | X | X | X | X | X |
Physical examination | Â | X | Â | Â | X |
Vital signs | Â | X | Â | X | X |
Anthropometry | Â | X | Â | Â | X |
Blood sample | X | Â | Â | X | X |
Glucose | X | Â | Â | Â | X |
DNA blood sample | X | Â | Â | Â | Â |
Testosterone | X | Â | Â | Â | X |
PSA | X | Â | Â | X | X |
Liver functions | X | Â | Â | X | X |
Renal functions | X | Â | Â | X | X |
Hematology | X | Â | Â | X | X |
Spare blood | X | Â | Â | X | X |
Rectal Ultrasound | Â | X | Â | Â | X |
Rectal Toucher | Â | X | Â | X | X |
DEXA full body | Â | X | Â | Â | X |
DEXA bone mineral density | Â | X | Â | Â | X |
Ultrasound abdominal fat mass | Â | X | Â | Â | X |
Pulse wave velocity (PWV) | Â | X | Â | Â | X |
Functional mobility | Â | X | Â | Â | X |
Cognition tests | Â | X | Â | Â | X |
Quality of Life (QoL) | Â | X | Â | Â | X |
ADAM/AMS questionnaire | X | Â | Â | Â | X |
Sexual functioning questionnaire | Â | X | Â | Â | X |
IPSS questionnaire | Â | X | X | X | X |
Randomization | Â | X | Â | Â | Â |