Back to resultsA 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)
Primary Purpose
Vaginosis, Bacterial, Candidiasis, Vulvovaginal
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
100 mg clindamycin /800 mg ketoconazole vaginal ovule
100 mg tetracycline hydrochloride /50 mg amphotericin B cream
Sponsored by
About this trial
This is an interventional treatment trial for Vaginosis, Bacterial
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
clindamycin/ketoconazole combination
tetracycline hydrochloride/amphotericin B combination
Arm Description
Outcomes
Primary Outcome Measures
Percentage of participants that obtain clinical cure
Percentage of participants that obtain microbiological cure
Secondary Outcome Measures
Full Information
NCT ID
NCT01293643
First Posted
February 9, 2011
Last Updated
August 7, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01293643
Brief Title
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)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginosis, Bacterial, Candidiasis, Vulvovaginal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
clindamycin/ketoconazole combination
Arm Type
Experimental
Arm Title
tetracycline hydrochloride/amphotericin B combination
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
100 mg clindamycin /800 mg ketoconazole vaginal ovule
Intervention Description
1 vaginal ovule for 3 consecutive days
Intervention Type
Drug
Intervention Name(s)
100 mg tetracycline hydrochloride /50 mg amphotericin B cream
Intervention Description
1 applicator (4 g) full of cream intravaginally for 7 to 10 days
Primary Outcome Measure Information:
Title
Percentage of participants that obtain clinical cure
Time Frame
Baseline up to Day 10
Title
Percentage of participants that obtain microbiological cure
Time Frame
Baseline up to Day 10
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
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)
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