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)

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Amphotericin B; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Ketoconazole; Liposomal amphotericin B; Tetracycline

Criteria

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