Conditions: Bacterial Vaginosis
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 325
Healthy volunteers: no

Brief summary:
This is a Phase 3, multi-center, prospective, open-label study to evaluate the safety of SYM-1219 granules containing 2 grams of secnidazole in women and postmenarchal adolescent girls with bacterial vaginosis.

Detailed description:
Approximately 325 patients will be enrolled. Patients determined to be eligible for the study will receive SYM-1219 granules containing 2 grams of secnidazole orally as a single dose.

Patients determined to be eligible at the Baseline visit will receive a single dose of SYM-1219 granules containing 2 grams of secnidazole in 4 ounces of unsweetened applesauce to be self-administered on Day 1. Patients will be contacted by telephone once between Days 8 to 10 to inquire about possible adverse events. A final study visit will occur on Day 21 to 30 to assess the patient for safety.

Arms:
arm 1: All pateints recieved single dose SYM-1219 Containing 2 Grams of Secnidazole

Interventions: intervention 1: SYM-1219
Intervention descriptions: intervention 1: Administered with 4 ounces of unsweetened applesauce, and 8 ounces of water

Protocol document: