ABSTRACT
I. Introduction.......................................................................................... 152
A. Physiology..................................................................................... 152
B. Goals of Testosterone Replacement ............................................. 152
II. General Design Considerations of TRT Trials ................................... 153
A. Serum Testosterone Levels........................................................... 153
B. Clinical Endpoints......................................................................... 154
1. Sexual Functions ..................................................................... 155
2. Bone Mineral Density............................................................. 155
3. Body Composition .................................................................. 155
III. Inclusion/Exclusion Criteria ................................................................ 156
A. Inclusion Criteria .......................................................................... 156
B. Exclusion Criteria ......................................................................... 156
IV. Efficacy ................................................................................................ 157
A. Serum T, Free T, DHT Levels ..................................................... 157
1. Normalization of Serum T Levels.......................................... 157
2. Analysis of T Levels............................................................... 158
3. Analysis of Free T and DHT.................................................. 158
B. Serum E2....................................................................................... 159
C. Clinical Endpoints......................................................................... 159
D. Sample Size Considerations ......................................................... 159
V. Safety ................................................................................................... 159
A. Prostate .......................................................................................... 160
VI. Conclusion ........................................................................................... 160
References........................................................................................................ 160
Testosterone (abbreviated as T in this chapter) in the male is associated with
sexual function and fertility, intellectual capacity, depression, fatigue, body
composition (muscle and fat mass), muscle strength, bone mineral density
(BMD), and red blood cell production.
