NCT02452866

Open-Label Study to Evaluate Safety of A Single Dose of SYM-1219

Multi-center, Prospective, Open-Label Study to Evaluate the Safety of A Single Dose of SYM-1219, a Granule Formulation Containing 2 Grams of Secnidazole, for the Treatment of Women and Postmenarchal Adolescent Girls With Bacterial Vaginosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 325 (actual)
• Sponsor: Symbiomix Therapeutics · Industry
• Sex: Female
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bacterial Vaginosis

Interventions

Type	Name	Description
DRUG	SYM-1219	Administered with 4 ounces of unsweetened applesauce, and 8 ounces of water

Timeline

• Start date: 2015-06-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2015-05-25
• Last updated: 2021-04-13
• Results posted: 2021-04-13

Locations

40 sites across 1 country: United States