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tetracycline/ amphotericin B

Phase 3

Vaginosis, Bacterial | Small molecule | Infectious Disease |Merck & Company, Inc.|Last Updated: Aug 10, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment99

FDA Designations

No designations recorded

Clinical trial landscape

tetracycline/ amphotericin B · 1 trial · 2 indications

Phase 3 1
NCT01293643A 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)Vaginosis, Bacterial
COMPLETED99 Analytics
PHASE3COMPLETED
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)
Vaginosis, Bacterial
NCT0129364399
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Study Endpoints

Primary Endpoints

Percentage of participants that obtain clinical cure
Baseline up to Day 10
Percentage of participants that obtain microbiological cure
Baseline up to Day 10
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
clindamycin/ketoconazole combinationEXPERIMENTAL -
tetracycline hydrochloride/amphotericin B combinationACTIVE_COMPARATOR -

Interventions

NameTypeDescription
100 mg clindamycin /800 mg ketoconazole vaginal ovuleDRUG1 vaginal ovule for 3 consecutive days
100 mg tetracycline hydrochloride /50 mg amphotericin B creamDRUG1 applicator (4 g) full of cream intravaginally for 7 to 10 days
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Eligibility Criteria

Age Range18 Years to 45 Years
SexFEMALE
Healthy VolunteersNo

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...

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