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)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Vaginosis, Bacterial, Candidiasis, Vulvovaginal

Intervention / Treatment
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* Drug: 100 mg clindamycin /800 mg ketoconazole vaginal ovule
* Drug: 100 mg tetracycline hydrochloride /50 mg amphotericin B cream


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: clindamycin/ketoconazole combination<br> | Drug: 100 mg clindamycin /800 mg ketoconazole vaginal ovule<br>* 1 vaginal ovule for 3 consecutive days<br>|
| Active Comparator: tetracycline hydrochloride/amphotericin B combination<br> | Drug: 100 mg tetracycline hydrochloride /50 mg amphotericin B cream<br>* 1 applicator (4 g) full of cream intravaginally for 7 to 10 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants that obtain clinical cure |  | Baseline up to Day 10 | 
| Percentage of participants that obtain microbiological cure |  | Baseline up to Day 10 |