Table 3.
Secondary efficacy outcomes
|
End of study |
Censored at 2% PRO2000 gel discontinuation, Feb 14, 2008 |
|||||
|---|---|---|---|---|---|---|
| 0·5% PRO2000 (n=3326) | Placebo (n=3325) | 2% PRO2000 (n=2734) | 0·5% PRO2000 (n=2732) | Placebo (n=2722) | ||
| Herpes simplex virus type 2 | ||||||
| Infection by week 40 | 59/890 (6·6%) | 66/907 (7·3%) | 18/395 (4·6%) | 22/374 (5·9%) | 22/380 (5·8%) | |
| Odds ratio | 0·90 (0·63–1·30) | 1 | 0·78 (0·41–1·47) | 1·01 (0·55–1·87) | 1 | |
| p value | 0·59 | .. | 0·44 | 0·55 | .. | |
| Infection by week 52 | 109/919 (11·9%) | 115/888 (13·0%) | 34/297 (11·5%) | 34/292 (11·6%) | 32/284 (11·3%) | |
| Odds ratio | 0·90 (0·68–1·20) | 1 | 1·01 (0·61–1·70) | 1·04 (1·62–1·73) | 1 | |
| p value | 0·48 | .. | 0·95 | 0·89 | .. | |
| Neisseria gonorrhoeae | ||||||
| Infection at week 24 (±4 weeks) | 77/2674 (2·9%) | 74/2597 (2·9%) | 42/1613 (2·6%) | 44/1632 (2·7%) | 48/1550 (3·1%) | |
| Odds ratio | 1·01 (0·73–1·40) | 1 | 0·85 (0·56–1·29) | 0·88 (0·56–1·29) | 1 | |
| p value | 0·95 | .. | 0·44 | 0·54 | .. | |
| Chlamydia trachomatis | ||||||
| Infection at week 24 (±4 weeks) | 159/2674 (6·0%) | 164/2597 (6·3%) | 79/1611 (4·9%) | 95/1632 (5·9%) | 90/1570 (5·8%) | |
| Odds ratio | 0·94 (0·75–1·17) | 1 | 0·82 (0·60–1·11) | 0·98 (0·73–1·31) | 1 | |
| p value | 0·58 | .. | 0·20 | 0·90 | .. | |
Data are n/n (%) or n (95% CI) unless otherwise stated. ..=not applicable.