Treatment of Bacterial Vaginosis (BV) With Tinidazole
Tinidazole for the Treatment of Bacterial Vaginosis
2 other identifiers
interventional
593
1 country
1
Brief Summary
We are trying to determine if treatment of bacterial vaginosis with tinidazole is better than treatment with metronidazole
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2004
Longer than P75 for phase_4
1 active site
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
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 7, 2006
CompletedFirst Posted
Study publicly available on registry
June 8, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
June 23, 2011
CompletedDecember 2, 2017
October 1, 2017
5.1 years
June 7, 2006
March 3, 2011
October 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cure of Bacterial Vaginosis
resolution of Amsel criteria for bacterial vaginosis
one month
Secondary Outcomes (1)
Recurrence of BV
baseline to 4 weeks
Study Arms (3)
control
ACTIVE COMPARATORmetronidazole 500 BID for 7 days
tinidazole 500
ACTIVE COMPARATORtinidazole 500 BID for 7 days
tinidazole 1 gm
ACTIVE COMPARATORtinidazole 1 gm BID for 7 days
Interventions
Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid
Eligibility Criteria
You may qualify if:
- Women be at least 18 years of age
- Have symptoms of vaginal odor and or/discharge
- Meet the clinical (Amsel) criteria for BV
- Willing to participate in research
You may not qualify if:
- Presence of another vaginal infection or STD
- Allergy to metronidazole
- Pregnant or nursing
- Use of oral or intravaginal antibiotics within the past 2 weeks
- HIV or other chronic disease
- Inability to keep return appointments
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jefferson County Department of Health STD Clinic
Birmingham, Alabama, 35294, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- jane R Schwebke, MD
- Organization
- University of Alabama at Birmingham
Study Officials
- PRINCIPAL INVESTIGATOR
Jane Schwebke, MD
University of Alabama at Birmingham
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 7, 2006
First Posted
June 8, 2006
Study Start
November 1, 2004
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
December 2, 2017
Results First Posted
June 23, 2011
Record last verified: 2017-10