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)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 3

Conditions

Vaginosis, Bacterial

Candidiasis, Vulvovaginal

Treatments

Drug: 100 mg clindamycin /800 mg ketoconazole vaginal ovule

Drug: 100 mg tetracycline hydrochloride /50 mg amphotericin B cream

Study type

Interventional

Funder types

Industry

Identifiers

NCT01293643

BR 001-09 (Other Identifier)

P08077

Details and patient eligibility

About

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.

Enrollment

99 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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