NCT02147899

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

A Phase 2, Multi-center, Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effectiveness and Safety of SYM-1219 for the Treatment of Women With Bacterial Vaginosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 215 (actual)
• Sponsor: Symbiomix Therapeutics · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

:This was a Phase 2, multi-center, prospective, randomized, double-blind, placebo-controlled study to evaluate the effectivenessand safety of SYM-1219 in women with bacterial vaginosis. Patients determined to be eligible for the study were randomized to one of the following treatments: SYM-1219 1 gram orallyas a single dose;SYM-1219 2 grams orally as a single dose;or matching placebo. Patients determined to be eligible based on the clinical assessments at the Baseline visit (Day 1) were randomized in a 1:1:1 ratio and received a singledose of the assigned study treatment on Day 1 under fasted conditions (i.e., no food 2 hours prior to or 1 hour after dosing). The centralized randomization was stratified by the number of reported episodes of BV in the past 12 months (including the current episode): 3 or fewer episodes versus 4 or more episodes. Patients were asked to complete a daily telephone questionnaire on Days1to7 and at the Test of Cure (TOC)/End of Study (EOS)visit. Patients were also contacted by telephone once on Day 8 to 10 to inquire about possible adverse events (AEs). A TOC visit was conducted between Day 21 and 30; or at EOSif the final visit was notconducted between Day 21and30

Conditions

• Bacterial Vaginosis

Interventions

Type	Name	Description
DRUG	SYM-1219	Oral
DRUG	Placebo	Oral

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2014-05-28
• Last updated: 2020-11-13
• Results posted: 2017-12-14

Locations

16 sites across 1 country: United States