Table 3.
Testosterone | Placebo | P-value* | |||||||
---|---|---|---|---|---|---|---|---|---|
Baseline | 8 Weeks | Baseline | 8 Weeks | ||||||
Mean | SD | Mean | SD | Mean | SD | Mean | SD | ||
Depression Symptom Severity | |||||||||
MADRS Score | 26.8 | 6.3 | 15.3 | 9.6 | 26.3 | 5.4 | 14.4 | 9.3 | 0.91 |
CGI-S Score | 4.3 | 0.6 | 3.1 | 1.4 | 4.3 | 0.6 | 2.8 | 1.2 | 0.78 |
IDS-SR | 35.9 | 10.5 | 20.1 | 11.2 | 34.9 | 10.0 | 19.1 | 10.1 | 0.81 |
Fatigue and Sleepiness | |||||||||
BFI | 6.2 | 1.9 | 4.0 | 2.3 | 5.6 | 2.0 | 3.7 | 2.8 | 0.92 |
ESS | 8.0 | 4.7 | 6.0 | 4.2 | 9.4 | 4.7 | 6.8 | 3.6 | 0.80 |
FSS | 45.0 | 12.5 | 38.6 | 13.8 | 42.4 | 12.3 | 35.9 | 13.9 | 0.81 |
Sexual Function | |||||||||
DISF | 32.8 | 27.3 | 45.1 | 31.3 | 38.7 | 30.1 | 47.5 | 34.0 | 0.37 |
Quality of Life | |||||||||
SF-36 PCS | 66.7 | 20.3 | 72.6 | 19.6 | 66.7 | 20.6 | 74.3 | 18.3 | 0.43 |
SF-36 MCS | 29.5 | 13 | 54.5 | 22.4 | 33.1 | 14.5 | 54.5 | 19.7 | 0.27 |
Hormone Levels | |||||||||
Total testosterone | 19 | 11 | 105 | 70 | 18 | 9 | 18 | 10 | p<0.0001 |
Free testosterone | 0.3 | 0.2 | 1.9 | 1.1 | 0.3 | 0.2 | 0.4 | 0.2 | p<0.001 |
P -value for comparison of change in psychiatric assessment or hormone level from baseline to 8 weeks in subjects randomized to receive testosterone vs placebo. For SF-36, lower scores indicate worse quality of life. For DISF, lower scores indicate worse sexual function. For all other scales/questionnaires, higher scores indicate worse symptom severity. Abbreviations: MADRS: Montgomery-Asberg Depression Rating Scale; CGI-S: Clinician Global Impressions-Severity Scale; IDS-SR: Inventory of Depressive Symptomology-Self-Report; BFI: Brief Fatigue Inventory; ESS: Epworth Sleepiness Scale; FSS: Fatigue Severity Scale; DISF: Derogatis Interview for Sexual Function; SF-36 PCS: Short Form-36 Physical Component Score; SF-36 MCS: Short Form-36 Mental Component Score.