Bacterial Vaginosis, Candidiasis
Conditions
Brief summary
The purpose of this study is to determine the Efficacy, Tolerability & Safety of Combination of Clindamycin 100mg and Ketoconazole 400mg in Vaginal Capsules, used for 7 consecutive days in patients with Mixed-Type Vaginosis compared to Combination of Tetracycline 100mg and Amphotericin B 50mg in Vaginal Cream.
Interventions
DRUGClindamycin 100mg and Ketoconazole 400mg
1 vaginal capsule once a day at night
DRUGTetracycline 100mg and Amphotericin B 50mg
One full applicator, once a day at night
Sponsors
Zodiac Produtos Farmaceuticos S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Mixed-type vaginosis * Bacterial vaginosis * Candidiasis
Exclusion criteria
* Pregnancy * Vaginal bleeding * History of recurrent vaginosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy based on cure rate evaluated by clinical and laboratory criteria. | 7 days |
Secondary
| Measure | Time frame |
|---|---|
| Tolerability based on adverse events reports and patient's information | 7 days |
| Safety based on adverse events reports and laboratory criterion | 7 days |
Countries
Brazil
Contacts
Primary ContactRogerio Bonassi Machado, MD
Backup ContactPaula Fabrini, MD
Outcome results
None listed