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NCT00635622 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of Lactobacillus Administered Vaginally in Women With Bacterial Vaginosis
A Phase 2 study, sponsored by Osel.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT00635622 is a Phase 2 study that has completed, run by Osel. The registered enrollment target is 40 participants.
The verdict
NCT00635622, a Phase 2 study, has completed, sponsored by Osel.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
This is a phase IIa clinical trial in women with bacterial vaginosis. This study will determine whether treatment with vaginal lactobacillus in combination with antibiotic therapy (metronidazole) is effective in colonizing the vagina with the lactobacillus bacteria found in normal vaginal flora.
Interventions
- DRUG LACTIN-V
- DRUG Placebo control substance
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2008-04 |
| Est. Completion | 2009-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00635622
The ClinicalTrials.gov registry entry for NCT00635622 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Osel, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which LACTIN-V is the first listed.
NCT00635622 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00635622 about?
NCT00635622 is a clinical study titled "Safety and Efficacy Study of Lactobacillus Administered Vaginally in Women With Bacterial Vaginosis". This is a phase IIa clinical trial in women with bacterial vaginosis. This study will determine whether treatment with vaginal lactobacillus in combination with antibiotic therapy (metronidazole) is effective in colonizing the vagina with the lactobacillus bacteria found in normal vaginal flora.
What is the current status of trial NCT00635622?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2008-04. Estimated completion is 2009-01.
What interventions are being tested in trial NCT00635622?
The interventions under investigation include: LACTIN-V (DRUG), Placebo control substance (DRUG).
Who is sponsoring clinical trial NCT00635622?
This trial is sponsored by Osel, which has 3 total clinical trials registered on ClinicalTrials.gov.
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