RESULTS OF RESEARCH OF SAFETY AND ACCEPTABILITY OF NEW FORMULIZATION OF DIINDOLYLMETHANE AT PATIENTS WITH HYPERPLASIA OF ENDOMETRIUM WITHOUT ATYPIA

The objective of research was the assessment of safety and acceptability of therapy by «Cineton» preparation on the basis of diindolylmethane (DIM) at patients with the diagnosis of hyperplasia of endometrium without atypia. Participants of research (81 patients) were randomized into 3 groups. Patients of the 1^st group received the studied preparation in a dose of 400 mg of DIM per day. Patients of the 2^nd group received the studied preparation in a dose of 600 mg of DIM per day. Patients of the 3^rdgroup received placebo. The patients received standard hormonal therapy within 160 days in addition to taking of the studied preparation and placebo. The assessment of safety and acceptability of therapy was carried out according to results of registration of the undesirable phenomena (UP) clinically and by means of tool and laboratory methods of research. Totally during research 16 UP (19,8 %) were registered generally from reproductive system, 7 UP were connected with the termination of taking of preparation (1 - in group of «Cineton» taking of 400 mg of DIM per day, 3 - in group of «Cineton» taking of 600 mg of DIM per day, 1 - in group of placebo). Differences between groups on the UP frequency and cases of intolerance when comparing with placebo group weren’t statistically significant at application of both doses.

3, 3’-дииндолилметан (ДИМ), 3, 3’-diindolylmethane (DIM), clinical trial, safety, acceptability, pluronic, hyperplasia of endometrium

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