Bacterial Vaginosis
Conditions
Brief summary
The purpose of this study is to determine if product 55394 is safe and efficacious for the treatment of bacterial vaginosis.
Interventions
DRUGProduct 55394
Product 55394 vaginal gel in a prefilled applicator.
DRUGPlacebo Vehicle (non-treatment)
The vehicle vaginal gel in an applicator (placebo).
Sponsors
Medicis Global Service Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a clinical diagnosis of bacterial vaginosis as determined by the investigator. * Other items as identified in the protocol.
Exclusion criteria
* Have a known or suspected other infectious cause of vulvovaginitis. * Other items as identified in the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Cure | Day 21 | The proportion of subjects with a clinical cure at the Day 21 visit, as assessed by the investigator. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Therapeutic Cure | Day 21 | The proportion of subjects with a therapeutic cure at the Day 21 visit. Therapeutic cure is defined as both a clinical cure and bacteriological cure as assessed by the investigator and the central laboratory, respectively. |
Countries
United States
Outcome results
None listed