Table 1.
Reasons for exclusion of subjects for analyses and baseline characteristics of evaluable subjects
| Group
|
All subjects | |||||||
|---|---|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | 6 | 7 | ||
| T gel dose (g) | 0 | 0 | 10 | 10 | 10 | 10 | 10 | |
| NES gel dose (mg) | 2 | 4 | 0 | 2 | 4 | 6 | 8 | |
| Randomized (n) | 20 | 20 | 20 | 20 | 20 | 20 | 20 | 140 |
| Withdrawn (n) | 1 | 0 | 0 | 0 | 2 | 0 | 2 | 5 |
| <80% compliant (n) | 1 | 0 | 0 | 0 | 2 | 0 | 1 | 4 |
| Sample >48 h after dose (n) | 0 | 2 | 1 | 0 | 0 | 1 | 0 | 4 |
| Nondetectable serum NES levels (n) | 2 | 2 | NA | 1 | 1 | 1 | 1 | 8 |
| Efficacy evaluable (n) | 16 | 16 | 19 | 19 | 15 | 18 | 16 | 119 |
| Age (yr)a | 32 (23–37) | 30 (23–36) | 35 (26–42) | 34 (24–42) | 35 (28–46) | 29 (26–39) | 29 (26–34) | 31 (25–39) |
| Caucasian (n) | 13 (81%) | 15 (94%) | 13 (68%) | 16 (84%) | 11 (73%) | 12 (67%) | 13 (81%) | 93 (78%) |
| Weight (lbs)a | 185 (155–203) | 181 (169–201) | 175 (164–194) | 193 (165–207) | 191 (160–207) | 162 (141–177) | 189 (164–209) | 179 (162–202) |
| BMI (kg/m2)a | 26.9 (23–29) | 25.0 (24–27) | 27.1 (24–29) | 25.5 (25–28) | 27.7 (24–30) | 24.9 (21–26) | 27.2 (24–29) | 25.9 (24–29) |
| Serum T (nmol/liter)a | 14.2 (10.1–18.4) | 16.1 (12.2–17.3) | 15.9 (13.2–20.3) | 16.2 (13.0–21.3) | 15.5 (13.5–19.1) | 19.6 (15.4–21.7) | 16.8 (13.4–19.8) | 16.3 (13.2–19.8) |
| Serum Free T (nmol/liter)a | 0.32 (0.25–0.41) | 0.32 (0.26–0.38) | 0.37 (0.29–0.47) | 0.33 (0.30–0.41) | 0.32 (0.25–0.36) | 0.31 (0.20–0.45) | 0.32 (0.21–0.36) | 0.33 (0.25–0.41) |
| Serum SHBG (nmol/liter)a | 30.1 (18.9–36.8) | 31.0 (23.4–41.0) | 24.5 (19.9–45.8) | 32.4 (27.2–41.4) | 35.6 (21.8–54.1) | 30.3 (20.0–42.1) | 21.5 (15.8–32.9) | 28.6 (20.8–41.5) |
BMI, Body mass index; NA, not applicaple.
a
Results are shown as median (first to third quartiles).