Candidiasis research study
What is the primary objective of this study?
Who is eligible to participate?
Inclusion Criteria: - Mixed-type vaginosis - Bacterial vaginosis - Candidiasis Exclusion Criteria: - Pregnancy - Vaginal bleeding - History of recurrent vaginosis
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Clindamycin 100mg and Ketoconazole 400mg1 vaginal capsule once a day at night
Drug:Tetracycline 100mg and Amphotericin B 50mgOne full applicator, once a day at night
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Clindamycin 100mg and Ketoconazole 400mg
Tetracycline 100mg and Amphotericin B 50mg
Start Date: September 2009
Completed Date: March 2010
Phase: Phase 3
Primary Outcome: Efficacy based on cure rate evaluated by clinical and laboratory criteria.
Secondary Outcome: Tolerability based on adverse events reports and patient's information
Study sponsors, principal investigator, and references
Principal Investigator: Rogerio Bonassi Machado, MD
Lead Sponsor: Zodiac Produtos Farmaceuticos S.A.