A Phase 2 Study of SYM-1219 to Treat Bacterial Vaginosis

Phase 2 Completed 215 enrolled Symbiomix Therapeutics

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this research study is to test the safety and effectiveness of the oral investigational new drug, SYM-1219, for the treatment of bacterial vaginosis.

Timeline

Start: 2014-05
Primary completion: 2014-10
Completion: 2014-10

Outcome

Met primary endpoint

paper (P<.05 for secnidazole compared with placebo; all endpoints). PMID 28697102 ↗

paper CONCLUSION: Oral granules containing 1 and 2 g secnidazole were superior to placebo in bacterial vaginosis treatment (P<.001 for both groups). PMID 28697102 ↗

Publications

Hillier SL, Nyirjesy P, Waldbaum AS, Schwebke JR, Morgan FG, Adetoro NA, Braun CJ. Secnidazole Treatment of Bacterial Vaginosis: A Randomized Controlled Trial. Obstet Gynecol. 2017 Aug;130(2):379-386. doi: 10.1097/AOG.0000000000002135.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Secnidazole	Small molecule	1 g	Oral
Subject	Secnidazole	Small molecule	2 g	Oral