Table 1.
Intervention | Group | Total | ||
---|---|---|---|---|
DIM | DIM | Placebo | ||
100 mg/day | 200 mg/day | |||
Number of patients enrolled | 26 | 26 | 26 | 78 |
Date of inclusion of the first patient | 10 December 2012 | 10 December 2012 | 21 December 2012 | |
Date of inclusion of the last patient | 21 November 2013 | 20 November 2013 | 20 November 2013 | |
Date of the last visit of the last patient | 4 April 2014 | 5 April 2014 | 15 April 2014 | |
Eliminated from the study due to withdrawal of consent to participate in the study prior to receiving the first dose of the drug and excluded from the analysis (both safety and efficacy) | 1 | 2 | 3 | 6 |
Eliminated from the study due to withdrawal of consent to participate in the study after the beginning of therapy | 2 | 4 | 4 | 10 |
Ceased to meet the criteria for participation in the study | 0 | 0 | 0 | 0 |
Excluded from the study for safety reasons ahead of schedule | 2 | 1 | 1 | 4 |
Completed visit procedure in 90 days of treatment in accordance with the study protocol and included in the efficacy analysis | 22 | 20 | 19 | 61 |
Stopped taking the drug due to CIN recovery after 90 days of therapy | 15 | 17 | 10 | 42 |
Completed visit procedures after 180 days of treatment in accordance with the study protocol and included in the efficacy analysis | 21 | 19 | 18 | 58 |
CIN cervical intraepithelial neoplasia, DIM 3,3′-diindolylmethane