Conditions: Bacterial Vaginosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 215
Healthy volunteers: no

Brief 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

Arms:
arm 1: Administered orally arm 2: Administered orally arm 3: Administered orally

Interventions: intervention 1: SYM-1219 intervention 2: Placebo
Intervention descriptions: intervention 1: Oral intervention 2: Oral

Protocol document: