Double-blind randomized placebo-controlled multicenter clinical trial (phase IIa) on XXXX 's efficacy and safety in the treatment of @entity3146 : implications for @entity5 prevention.

@entity5 @entity1 @entity13589 @entity3146
BACKGROUND: The article presents the results of a clinical trial on the efficacy and safety of a novel pharmaceutical composition in the form of vaginal suppositories containing @entity13589 in the course of @entity3146 ( @entity3146 ) I-II conservative treatment. It offers an attractive drug therapy for more personalized prevention of @entity5 . METHODS: A total of 78 @entity1 of reproductive age were included. This was a multicenter, randomized, placebo-controlled, double-blind, parallel-group trial with efficacy determined by histological evaluation of cervical biopsies. The efficacy of active drug treatment (100 and 200  mg/day) in both treatment groups was significantly higher in comparison with the placebo group, according to the primary efficacy end point (proportion of @entity1 with complete @entity3146 regression after 90-180  days of the study drug treatment). RESULTS: The efficacies were 100.0  % (confidence interval (CI) 95  %: 82.35-100.00  %), 90.5  % (CI 95  %: 69.62-98.83  %), and 61.1  % (CI 95  %: 35.75-82.70  %), for the high dose, low does, and placebo, respectively. Adverse events in the placebo group were reported in 22  % of @entity1 (CI 95  %: 7.5-43.7  %); in the first treatment group (100  mg/day), adverse events were reported in 40.0  % of @entity1 (CI 95  %: 21.1-61.3  %); in the second treatment group (200  mg/day), adverse events were reported in 42.0  % of @entity1 (CI 95  %: 22.1-63.4  %). The differences in side effects between treatment groups treated with the active drug and placebo were statistically significant. No serious adverse events were reported in any of the groups. CONCLUSIONS: Thus, the use of @entity13589 in the form of intravaginal suppositories can be effective in @entity1 with @entity3146 and is not accompanied by clinically significant side effects. This approach could be a better option for young @entity1 with @entity3146 as it takes in attention their reproductive plans. TRIAL REGISTRATION: ID: ChiCTR-INR-15007497 (2 December 2015).
