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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: Completed Phase 2 study, sponsored by Osel.
NCT00635622 is a Phase 2 study that has completed, run by Osel. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00635622 record still lists
NCT00635622 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which LACTIN-V is the first listed.
NCT00635622 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00635622's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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