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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Metronidazole Vaginal Gel 1.3% administered via applicator
Allergan Research Site #318
Long Beach, California, United States
Allergan Research Site #324
Paramount, California, United States
Allergan Research Site #315
Bardstown, Kentucky, United States
Allergan Research Site #314
New Orleans, Louisiana, United States
Number of subjects with treatment-emergent adverse events (AEs), serious AEs, treatment-related AEs and AEs leading to study discontinuation after Metronidazole Vaginal Gel is administered in post-menarcheal, adolescent females with bacterial vaginosis.
No serious AEs reported during the completed study
Time frame: up to 10 days
A multicenter open label to evaluate safety and tolerability of metronidazole vaginal gel 1.3% for adolescents female subject with bacterial and vaginosis
Metronidazole Vaginal Gel 1.3% is safe, well tolerated, and efficacious in treating vaginal discharge and odor in adolescent females aged 12 to \< 18 years with bacterial vaginosis. The safety and efficacy profiles in this study were consistent with the known safety and efficacy profiles for the adult population and no new safety concerns were identified.
Time frame: up tp 10 days
Number of subjects reporting presence of daily vaginal discharge and/or odor following single dose administration of Metronidazole Vaginal Gel 1.3%assessment of the presence of vaginal discharge and odor following single dose administration.
no order or smelling observed
Time frame: up to 10 days
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Allergan Research Site #319
Columbus, Ohio, United States
Allergan Research Site #322
Dayton, Ohio, United States
Allergan Research Site #321
Memphis, Tennessee, United States
Allergan Research Site #316
Irving, Texas, United States