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NCT00537576 · ClinicalTrials.gov registry record · Phase 1
Safety Study of Lactobacillus Administered Vaginally to Healthy Women
A Phase 1 study, sponsored by Osel.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT00537576: Completed Phase 1 study, sponsored by Osel.
NCT00537576 is a Phase 1 study that has completed, run by Osel. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00537576, a Phase 1 study, has completed, sponsored by Osel.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the safety, tolerability, and acceptability of LACTIN-V (Active Ingredient: Lactobacillus crispatus CTV-05) with a matching placebo at three doses using pre-filled vaginal applicators in healthy pre-menopausal women. The study hypothesis is that LACTIN-V will be safe, tolerable, and acceptable at each dose and will not differ significantly from the placebo controls.
Primary Outcome
Safety was measured by comparing the number of women experiencing adverse events of grade 3 or higher during the study.
Interventions
- BIOLOGICAL Low dose LACTIN-V applicator
- BIOLOGICAL Medium dose LACTIN-V applicator
- BIOLOGICAL High dose LACTIN-V applicator
- OTHER Low dose Placebo applicator
- OTHER Medium dose Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2007-11 |
| Est. Completion | 2008-04 |
| Phase | Phase 1 |
What the finished NCT00537576 record still lists
NCT00537576 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 5 interventions - of which Low dose LACTIN-V applicator is the first listed.
NCT00537576 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00537576 about?
NCT00537576 is a clinical study titled "Safety Study of Lactobacillus Administered Vaginally to Healthy Women". The purpose of this study is to compare the safety, tolerability, and acceptability of LACTIN-V (Active Ingredient: Lactobacillus crispatus CTV-05) with a matching placebo at three doses using pre-filled vaginal applicators in healthy pre-menopausal women. The study hypothesis is that LACTIN-V will ...
What is the current status of trial NCT00537576?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2007-11. Estimated completion is 2008-04.
What interventions are being tested in trial NCT00537576?
The interventions under investigation include: Low dose LACTIN-V applicator (BIOLOGICAL), Medium dose LACTIN-V applicator (BIOLOGICAL), High dose LACTIN-V applicator (BIOLOGICAL), Low dose Placebo applicator (OTHER), Medium dose Placebo (OTHER).
Who is sponsoring clinical trial NCT00537576?
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 NCT00537576's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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