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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: Completed NA study, sponsored by Johnson & Johnson Consumer and Personal Products Worldwide.
NCT00913523 is a NA study that has completed, run by Johnson & Johnson Consumer and Personal Products Worldwide. The registered enrollment target is 482 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Percentage of subjects showing unfavorable changes of at least 1-log in lactobacilli (decrease), C. albicans (increase), or G. vaginalis (increase)
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 |
What the finished NCT00913523 record still lists
NCT00913523 is an interventional study that assigns participants to a tested intervention. The registered 482 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 2 interventions - of which Experimental - Tampon with GML is the first listed.
NCT00913523 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00913523's enrollment target sits among peer trials
482 216th of 2000 higher than 1,785 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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