NCT02392026

Safety and Tolerability of Metronidazole Gel 1.3%

A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Metronidazole Vaginal Gel 1.3% in Adolescent Female Subjects With Bacterial Vaginosis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Insud Pharma · Industry
• Sex: Female
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

Multicenter, open-label study to evaluate safety and tolerability of Metronidazole Vaginal Gel in females 12 to \<18 years for the treatment of bacterial vaginosis.

Detailed description

A multicenter, open-label study to evaluate safety and tolerability of Metronidazole Vaginal Gel 1.3% when administered as a single dose in adolescent females (aged 12 to \<18 years) for the treatment of bacterial vaginosis.

Conditions

• Vaginosis, Bacterial

Interventions

Type	Name	Description
DRUG	Metronidazole Gel	Metronidazole Vaginal Gel 1.3% administered via applicator

Timeline

• Start date: 2015-08-12
• Primary completion: 2016-10-05
• Completion: 2016-10-05
• First posted: 2015-03-18
• Last updated: 2023-08-15

Locations

8 sites across 1 country: United States