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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.

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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

FieldValue
Enrollment Target 40 participants
Start Date 2008-04
Est. Completion 2009-01
Phase Phase 2

Sponsor

Osel

3 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.