Table 1.
Baseline characteristics
| 2% PRO2000*(n=2734) | 0·5% PRO2000 (n=3326) | Placebo (n=3325) | ||
|---|---|---|---|---|
| Demographic | ||||
| Age (years) | ||||
| 15–24 | 1022/2734 (37%) | 1249/3326 (38%) | 1267/3324 (38%) | |
| 25–34 | 955/2734 (35%) | 1076/3326 (32%) | 1096/3324 (33%) | |
| 35–44 | 532/2734 (19%) | 723/3326 (22%) | 702/3324 (21%) | |
| ≥45 | 225/2734 (8%) | 278/3326 (8%) | 259/3324 (8%) | |
| Education | ||||
| None | 177/2734 (6%) | 240/3326 (7%) | 233/3324 (7%) | |
| Primary | 1927/2734 (70%) | 2309/3326 (69%) | 2271/3324 (68%) | |
| Secondary or higher | 630/2734 (23%) | 777/3326 (23%) | 820/3324 (25%) | |
| Medical history (ever) | ||||
| Non-menstrual bleeding | 266/2734 (10%) | 339/3326 (10%) | 307/3325 (9%) | |
| Sores or ulcers | 294/2734 (11%) | 357/3326 (11%) | 342/3325 (10%) | |
| Unusual genital discomfort | 656/2734 (24%) | 786/3326 (24%) | 820/3325 (25%) | |
| Unusual genital discharge | 686/2734 (25%) | 796/3326 (24%) | 820/3325 (25%) | |
| Pain during sex | 140/2734 (5%) | 181/3326 (5%) | 163/3325 (5%) | |
| Other genital disorders | 22/2734 (1%) | 21/3326 (1%) | 28/3325 (1%) | |
| Positive laboratory results | ||||
| Chlamydia trachomatis | 202/2698 (7%) | 256/3293 (8%) | 266/3295 (8%) | |
| Neisseria gonorrhoeae | 93/2698 (3%) | 110/3293 (3%) | 119/3295 (4%) | |
| Herpes simplex virus type 2 seropositive | 1622/2725 (60%) | 2029/3312 (61%) | 1982/3311 (60%) | |
| Syphilis† | 106/2726 (4%) | 116/3300 (4%) | 137/3304 (4%) | |
| Trichomonas vaginalis | 268/2723 (10%) | 312/3314 (9%) | 314/3311 (9%) | |
| Behavioural | ||||
| Effective contraception‡ | 1514/2732 (55%) | 1850/3326 (56%) | 1873/3325 (56%) | |
| Sex acts in previous week | ||||
| 0 | 542/2732 (20%) | 627/3326 (19%) | 610/3325 (19%) | |
| 1 | 433/2732 (16%) | 573/3326 (17%) | 534/3325 (17%) | |
| ≥2 | 1754/2732 (64%) | 2124/3326 (64%) | 2178/3325 (64%) | |
| Missing/unknown | 3/2732 (<1%) | 2/3326 (<1%) | 3/3325 (<1%) | |
| Partners in previous week (median [IQR]) | 1 (1–1) | 1 (1–1) | 1 (1–1) | |
| Condom use at last sex act | 1500/2732 (55%) | 1894/3326 (57%) | 1826/3325 (55%) | |
| Anal sex in previous 4 weeks | 28/2732 (1%) | 42/3326 (1%) | 31/3325 (1%) | |
Data are n/n of participants with reported data (%) unless otherwise stated.
*
2% PRO2000 gel was discontinued Feb 14, 2008.
†
Active syphilis was defined on the basis of rapid plasma reagin titre.
‡
Sterilisation, intrauterine contraceptive device, or use of injected, implanted, or oral contraception.