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NCT00510614 · ClinicalTrials.gov registry record · Early Phase 1
Tinidazole for Recurrent Bacterial Vaginosis: A Pilot Study
A Early Phase 1 study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 37
- Enrollment target
NCT00510614 is a Early Phase 1 study that has completed, run by University of Pittsburgh. The registered enrollment target is 37 participants.
The verdict
NCT00510614, a Early Phase 1 study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 37 participants
- Enrollment target
Study Summary
This research study is being done to evaluate the use of an oral (by mouth) medication called tinidazole to initially treat BV and then to see if additional treatment with tinidazole keeps women from getting this infection back within 3 months. Tinidazole is currently approved by the United States Food and Drug Administration (FDA) to treat bacterial vaginosis (BV). This study will evaluate the use of tinidazole to treat a woman's current BV infection and then will look at using tinidazole as a suppressive treatment (taking medication regularly to attempt to decrease the "bad" bacteria from growing back). The suppressive treatment phase will include using tinidazole twice a week compared to using placebo twice a week and then following women for recurrence of BV. The purpose of this study is to determine if tinidazole suppression will prevent BV from coming back within 3 months of treatment. The investigators hypothesize that women with a history of recurrent bacterial vaginosis who are randomized to a suppressive regimen (a dose of medication given on a regular basis to attempt to control the bacteria that causes bacterial vaginosis) of tinidazole will have lower recurrence rates and a longer time to recurrence of bacterial vaginosis when compared to those women randomized to placebo.
Interventions
- DRUG Placebo
- DRUG tinidazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2007-10 |
| Est. Completion | 2009-09 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00510614
The ClinicalTrials.gov registry entry for NCT00510614 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00510614 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00510614 about?
NCT00510614 is a clinical study titled "Tinidazole for Recurrent Bacterial Vaginosis: A Pilot Study". This research study is being done to evaluate the use of an oral (by mouth) medication called tinidazole to initially treat BV and then to see if additional treatment with tinidazole keeps women from getting this infection back within 3 months. Tinidazole is currently approved by the United States F...
What is the current status of trial NCT00510614?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 37 participants. The study started on 2007-10. Estimated completion is 2009-09.
What interventions are being tested in trial NCT00510614?
The interventions under investigation include: Placebo (DRUG), tinidazole (DRUG).
Who is sponsoring clinical trial NCT00510614?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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