A Phase 2 interventional study of Oral tinidazole in Recurrent Bacterial Vaginosis, sponsored by Kaiser Permanente. Withdrawn at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2012-08-02.
Sponsored by Kaiser Permanente · Phase 2, Interventional, and Treatment
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 a week for 12 weeks.
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. After initial screening to make sure that the vaginal symptoms are due to bacterial vaginosis and not the results of a different infection, all of the women will receive tinidazole (a drug that is similar to metronidazole) by mouth for 10 days. At the end of the 10 days, patients will be re-examined. Those women who are free of bacterial vaginosis will enter the second phase of the study, where half of the patients will continue to take tinidazole twice a week for twelve weeks and the other half will take no medication. During this time participants will be examined by the study doctor every 4 weeks to see how effective the treatment has been at preventing the recurrence of bacterial vaginosis. At the end of the 12 weeks, women who are still free of bacterial vaginosis will be seen for 3 more visits over 3 months.
220 studies on the registry are indexed under Vaginosis, Bacterial; 36 are open to participants now.
Browse Vaginosis, Bacterial studies →Kaiser Permanente is the lead sponsor of 385 studies on the registry; 41 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Efficacy of oral tinidazole for treatment of recurrent bacterial vaginosis
Efficacy of oral tinidazole for prevention of recurrent bacterial vaginosis
Patient satisfaction with tinidazole for recurrent bacterial vaginosis
This study is withdrawn, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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