A Study to Compare the Efficacy and Safety of a Combination of Ketoconazole and Clindamycin Compared to Tetracycline/Amphotericin B Combination Cream for the Treatment of Bacterial Vaginosis and Vaginal Candidiasis (P08077)

A Phase 3b, Comparative and Randomized Study to Assess the Efficacy and Safety of an Intravaginal Ovule Combination of Ketoconazole and Clindamycin Compared With an Intravaginal Cream Combination of Tetracycline and Amphotericin B for the Treatment of Bacterial Vaginosis and Vaginal Candidiasis, Either Mixed or Isolated

This is a study to compare the safety and efficacy of the use of a intravaginal ovule containing a combination of Ketoconazole and Clindamycin to the use of an intravaginal cream containing a combination Tetracycline and Amphotericin B for the treatment of bacterial vaginosis and/or mixed or isolated vaginal candidiasis.

Inclusion Criteria:

• Diagnosis of vaginal candidiasis
• No Trichomonas vaginalis or any other protozoa
• No clinical evidences of infection by Neisseria gonorrhoeae, Chlamydia trachomatis, or viral infections

Exclusion Criteria:

• Known sensitivity to the formula components
• Pregnant or nursing patients
• Any gynecological condition contraindicating the use of vaginal ovule or cream.
• Use of any other local or systemic bactericidal, anti-protozoa or antifungal agent within the 2 weeks prior to the study start or during it
• Presence of other sexually transmitted diseases (except from Candidal vaginitis).
• History of recurrent candidiasis (≥4 episodes per year)
• Use of intra-uterine device, spermicides, or diaphragms
• Has metabolic or immune disorder
• Has abnormal uterine bleeding