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)
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
2 other identifiers
interventional
99
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2010
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 9, 2011
CompletedFirst Posted
Study publicly available on registry
February 10, 2011
CompletedAugust 10, 2015
August 1, 2015
8 months
February 9, 2011
August 7, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of participants that obtain clinical cure
Baseline up to Day 10
Percentage of participants that obtain microbiological cure
Baseline up to Day 10
Study Arms (2)
clindamycin/ketoconazole combination
EXPERIMENTALtetracycline hydrochloride/amphotericin B combination
ACTIVE COMPARATORInterventions
1 vaginal ovule for 3 consecutive days
1 applicator (4 g) full of cream intravaginally for 7 to 10 days
Eligibility Criteria
You may qualify if:
- Diagnosis of vaginal candidiasis
- No Trichomonas vaginalis or any other protozoa
- No clinical evidences of infection by Neisseria gonorrhoeae, Chlamydia trachomatis, or viral infections
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2011
First Posted
February 10, 2011
Study Start
May 1, 2010
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
August 10, 2015
Record last verified: 2015-08