Safety of the pharmaceutical composition comprising dim in suppository form in patients with CIN 1-2 (phase II)

Abstract Purpose of the study: To evaluate safety of the novel pharmaceutical composition «Cervicon-DIM» in suppository form containing 3,3’-diindolylmethane (DIM) substance in patients with cervical intraepithelial neoplasia grade 1-2 (CIN 1-2). Materials and methods: 78 patients with CIN 1-2 were included and randomized to three groups. The patients in the first study group received 100 mg DIM intravaginally per day. In the second study group patients received 200 mg DIM intravaginally per day. In the control group patients received placebo. Patients were followed for six months. Safety was evaluated by adverse events (AEs), laboratory tests and physical examinations. Results: We noted total 34 AEs: 13 in group 100 mg DIM per day, 14 in group 200 mg DIM per day, 7 in placebo group. An association between treatment and AEs was registered for 4 cases. In other cases, the relationship of AEs with study drug was assessed as unlikely. All registered AEs had non-severe form. Serious adverse events haven’t been observed. Conclusions: We confirmed safety and good tolerability of novel DIM-based formulation.