Table 1.
Sexual Function Trial Outcomes.*
| Cohort and Outcome | No. of Men | Baseline Value | Change from Baseline Value | Treatment Effect (95% CI)† | Effect Size (95% CI)‡ | P Value§ | |||
|---|---|---|---|---|---|---|---|---|---|
| Month 3 | Month 6 | Month 9 | Month 12 | ||||||
| Men enrolled in Sexual Function Trial | |||||||||
| Primary outcome: PDQ-Q4 score¶ | |||||||||
| Testosterone | 230 | 1.4±1.3 | 0.6±1.3 | 0.6±1.5 | 0.5±1.5 | 0.2±1.6 | 0.58 (0.38–0.78) | 0.45 (0.30–0.60) | <0.001 |
| Placebo | 229 | 1.4±1.3 | 0.1±1.1 | −0.1±1.2 | −0.1±1.2 | −0.1±1.4 | |||
| Secondary outcomes | |||||||||
| DISF-M-II sexual desire score|| | |||||||||
| Testosterone | 234 | 11.9±6.7 | 3.5±6.3 | 3.5±6.0 | 4.0±7.4 | 2.6±6.5 | 2.93 (2.13–3.74) | 0.44 (0.32–0.56) | <0.001 |
| Placebo | 236 | 11.6±6.6 | 0.7±5.8 | 0.8±5.6 | 0.9±5.5 | 0.0±5.0 | |||
| IIEF erectile function score** | |||||||||
| Testosterone | 234 | 8.0±8.2 | 3.4±6.1 | 3.3±6.5 | 3.4±6.9 | 3.1±6.9 | 2.64 (1.68–3.61) | 0.32 (0.20–0.44) | <0.001 |
| Placebo | 236 | 7.7±8.2 | 1.0± 5.3 | 0.5±6.1 | 0.5±7.1 | 1.0±6.0 | |||
| All Testosterone Trials participants†† | |||||||||
| PDQ-Q4 score¶ | |||||||||
| Testosterone | 387 | 1.5±1.3 | 0.7±1.3 | 0.6±1.6 | 0.6±1.6 | 0.3±1.7 | 0.62 (0.45–0.79) | 0.45 (0.33–0.58) | <0.001 |
| Placebo | 384 | 1.5±1.4 | 0.0±1.2 | −0.1±1.3 | −0.1±1.3 | −0.1±1.4 | |||
Plus–minus values are means ±SD.
The treatment effect is the mean difference in change from baseline for participants assigned to testosterone versus those assigned to placebo, with adjustment for balancing factors: baseline total testosterone level (≤200 or >200 ng per deciliter), age (≤75 or >75 years), trial site, participation in the main trials, use or nonuse of antidepressants, and use or nonuse of phosphodiesterase type 5 inhibitors.
The effect size is the treatment effect divided by the baseline standard deviation.
The P value for the treatment effect was determined with the use of a linear mixed model with a random effect for participant.
Scores for sexual activity (question 4) on the Psychosexual Daily Questionnaire (PDQ-Q4) range from 0 to 12, with higher scores indicating more activity.
Scores on the sexual-desire domain of the Derogatis Interview for Sexual Functioning in Men–II (DISF-M-II) range from 0 to 33, with higher scores indicating greater desire.
Scores on the erectile-function domain of the International Index of Erectile Function (IIEF) range from 0 to 30, with higher scores indicating better function.
The outcomes for all Testosterone Trials participants are exploratory outcomes.