Status:
WITHDRAWN
A Pilot Study of Oral Tinidazole for Women With Recurrent Bacterial Vaginosis
Lead Sponsor:
Kaiser Permanente
Conditions:
Recurrent Bacterial Vaginosis
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
Brief Summary
This is a study of the drug tinidazole for women with recurrent bacterial vaginosis. Half of the participants will get the drug for 10 days, the other half will get the drug for 10 days and then twice...
Detailed Description
This study will recruit 60 women with recurrent bacterial vaginosis. These women must have a current infection to be enrolled in the study and have had two other infections within the past 12 months. ...
Eligibility Criteria
Inclusion
- Current infection with bacterial vaginosis
- 2 previous episodes of bacterial vaginosis within the past 12 months
- Willing to use contraception
- Able to swallow pills
- Willing to refrain from douching or using vaginal products
- Willing to refrain from alcohol consumption 24 hours before and for 72 hours after taking study medication (tinidazole)
Exclusion
- Women with same sex partners
- Menstruating at initial exam
- Presence of yeast, a sexually transmitted disease, or other vaginal infection
- Purulent cervical discharge
- Use of any drug for bacterial vaginosis or yeast within the past 2 weeks prior to enrollment
- Pregnant or nursing
- Taking lithium
- Taking blood thinners (anticoagulation therapy)
- Use of any investigational drug within the previous 30 days
- Active HPV infection requiring treatment
- Use of drugs that suppress the immune system
- History of alcoholism
- Taking disulfiram
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00324142
Last Update
August 2 2012
Active Locations (1)
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1
Kaiser Permanente
San Francisco, California, United States, 94115