Table 1. Two independently conducted, randomized, double-blind, placebo-controlled phase II clinical trials used to assess the efficacy of progesterone in TBI patients.
| Characteristics | Wright et al21 | Xiao et al20 |
|---|---|---|
| Country | US | China |
| Glasgow coma scale (GCS) | 4 to 12 | ≤8 |
| Time after injury | <11 h | <8 h |
| Delivery method (length) | Intravenous (3 d) | Intramuscular (5 d) |
| Outcome assessment post-injury | 30 d | 3 and 6 months |
| Randomization (progesterone:placebo) | 4:1 | 1:1 |
| Patients | 100 | 159 |
| Progesterone | 77 | 77 |
| Placebo | 23 | 82 |
| Primary endpoint | GOS-E; DRS and Mortality | GOS; Mortality and the modified FIM |
GOS, glasgow outcome scale; GOS-E, glasgow outcome scale-extended; DRS, disability rating scale; FIM, functional independence measure.