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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 is a Phase 1 study that has completed, run by Osel. The registered enrollment target is 12 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00537576
The ClinicalTrials.gov registry entry for NCT00537576 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 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 5 interventions - of which Low dose LACTIN-V applicator is the first listed.
NCT00537576 reports 0 study locations.
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.
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