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NCT00913523 · ClinicalTrials.gov registry record · NA
Clinical Evaluation of Effects of an Investigational Tampon on Vaginal Microflora
A NA study, sponsored by Johnson & Johnson Consumer and Personal Products Worldwide.
- Completed
- Registry status
- NA
- Development phase
- 482
- Enrollment target
NCT00913523 is a NA study that has completed, run by Johnson & Johnson Consumer and Personal Products Worldwide. The registered enrollment target is 482 participants.
The verdict
NCT00913523, a NA study, has completed, sponsored by Johnson & Johnson Consumer and Personal Products Worldwide.
- COMPLETED
- Registry status
- NA
- Development phase
- 482 participants
- Enrollment target
Study Summary
Subjects will be using investigational or control tampons during their menstrual period but these tampons are not intended to prevent, treat or diagnose an infection or other disease condition. A total 450 women will participate in this study at two study sites. Subjects will be randomly assigned to one of three tampon groups. The first group will test an experimental test tampon containing glycerol monolaurate (GML) on the cover. The second group will test an identical tampon, but without GML. The third group will not be issued study tampons but will be instructed to use their normal tampon brand. This study is intended to determine whether the effects of GML observed in the laboratory can be demonstrated in healthy menstruating women.
Interventions
- DEVICE Experimental - Tampon with GML
- DEVICE Sham Control - Tampons without GML
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 482 participants |
| Start Date | 2009-01 |
| Est. Completion | 2009-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00913523
The ClinicalTrials.gov registry entry for NCT00913523 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 482 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johnson & Johnson Consumer and Personal Products Worldwide, which has 26 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Experimental - Tampon with GML is the first listed.
NCT00913523 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00913523 about?
NCT00913523 is a clinical study titled "Clinical Evaluation of Effects of an Investigational Tampon on Vaginal Microflora". Subjects will be using investigational or control tampons during their menstrual period but these tampons are not intended to prevent, treat or diagnose an infection or other disease condition. A total 450 women will participate in this study at two study sites. Subjects will be randomly assigned to...
What is the current status of trial NCT00913523?
This trial is currently completed. It is a NA study. The enrollment target is 482 participants. The study started on 2009-01. Estimated completion is 2009-08.
What interventions are being tested in trial NCT00913523?
The interventions under investigation include: Experimental - Tampon with GML (DEVICE), Sham Control - Tampons without GML (DEVICE).
Who is sponsoring clinical trial NCT00913523?
This trial is sponsored by Johnson & Johnson Consumer and Personal Products Worldwide, which has 26 total clinical trials registered on ClinicalTrials.gov.
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