Table 2.
Primary endpoint: Regression rate of the combination of histological or cytological findings of CIN2 and CIN1 p16 positive after 3 months treatment with SAM gel among patients by SAM gel and control arm
| Regression (primary endpoint) | Active arm | Control arm | p between arms* | ||||
|---|---|---|---|---|---|---|---|
| Visit 1—Visit 3 | Cytology | Histology | Cyto or Histo | Cytology | Histology | Cyto or Histo | |
| Present (success) | 77 (71.3%) | 19 (86.4%) | 78 (72.2%) | 27 (25.0%) | 2 (20.0%) | 27 (25.0%) | P < 0.001 |
| Absent (failure) | 31 (28.7%) | 3 (13.6%) | 30 (27.8%) | 81 (75.0%) | 8 (80.0%) | 81 (75.0%) | |
| Total | 108 (100.0%) | 22 (100.0%) | 108 (100.0%) | 108 (100.0%) | 10 (100.0%) | 108 (100.0%) | |
*Pearson’s chi-squared test/two-sample proportional test