Table 1.
Patient disposition and baseline demographics/clinical characteristics
| Category | Treatment arm | |||
|---|---|---|---|---|
| 50 mg SC TE | 100 mg SC TE | 200 mg IM TE | Total | |
| Enrolled—n (%) | 14 (100) | 15 (100) | 10 (100) | 39 (100) |
| Mean age (SD) | 54.0 (12.4) | 54.7 (12.8) | 48.9 (10.9) | 52.9 (12.1) |
| Race—n (%) | ||||
| Caucasian | 14 (100) | 13 (86.7) | 8 (80.0) | 35 (89.7) |
| African descent | 0 (0.0) | 2 (13.3) | 1 (10.0) | 3 (7.7) |
| Multiple | 0 (0.0) | 0 (0.0) | 1 (10.0) | 1 (2.6) |
| Ethnicity—n (%) | ||||
| Hispanic or Latino | 0 (0.0) | 0 (0.0) | 2 (20.0) | 2 (5.1) |
| Not Hispanic or Latino | 14 (100.0) | 15 (100.0) | 8 (80.0) | 37 (94.9) |
| Enrollment status—n (%) | ||||
| Treatment naïve | 13 (92.9) | 13 (86.7) | ||
| Requiring washout | 1 (7.1) | 2 (13.3) | ||
| Mean BMI—kg/m2 at screening (SD) | 28.51 (2.17) | 29.19 (2.87) | 29.05 (2.21) | 28.91 (2.43) |
| Mean weight—kg at screening (SD) | 91.75 (10.27) | 93.16 (12.27) | 90.35 (12.03) | 91.93 (11.27) |
| Mean height—cm at screening (SD) | 179.21 (4.98) | 178.50 (8.39) | 176.02 (8.02) | 178.12 (7.16) |
| Mean baseline TT—ng/dL (SD) | 214.64 (59.05) | 201.50 (71.53) | 735.10 (187.96) | |
| Safety population*—n (%) | 14 (100) | 15 (100) | 10 (100) | 39 (100) |
| Pharmacokinetic population † —n (%) | 14 (100) | 15 (100) | 10 (100) | 39 (100) |
| Completed the study—n (%) | 14 (100) | 15 (100) | 9 (90) | 38 (97.4) |
| Discontinued from the study—n (%) | 0 (0.0) | 0 (0.0) | 1 (10.0) | 1 (2.6) |
| Primary reason for discontinuation: Other—n (%) | 0 (0.0) | 0 (0.0) | 1 (10.0) | 1 (2.6) |
*The safety population consisted of all patients who were randomized to treatment and received at least one dose of study medication. †The pharmacokinetic population consisted of all patients from the safety population who did not have a major protocol deviation that would impact the integrity of the PK data following dose administration and had at least one valid plasma concentration value post‐dose. For SC TE treatments, baseline TT was the measurement at SV2 for treatment‐naïve patients and the average of measurements at SV2 and SV3 for patients receiving any buccal or transdermal T treatment. If retest of TT happened because of a sample being ≥300 ng/dL, the average of two of the three samples with TT levels <300 ng/dL was used to calculate the baseline. For the 200 mg IM TE arm, baseline TT was the measurement at QV. If retest of the QV was needed, the retest value was used for baseline. BMI = body mass index; IM = intramuscular; PK = pharmacokinetic; QV = qualifying visit; SC = subcutaneous; SD = standard deviation; SV = screening visit; T = testosterone; TE = testosterone enanthate; TT = total testosterone