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Clinical Evaluation of Effects of an Investigational Tampon on Vaginal Microflora

NCT00913523 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 482

Last updated 2011-08-23

Study results available
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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.

Conditions

  • Vaginal Microflora

Interventions

DEVICE

Experimental - Tampon with GML

Regular and Super Tampon with Glycerol Monolaurate (GML) added to the cover

DEVICE

Sham Control - Tampons without GML

There is no intervention associated with these arms - they are sham controls.

Sponsors & Collaborators

  • Johnson & Johnson Consumer and Personal Products Worldwide

    lead INDUSTRY

Principal Investigators

  • David J Chase, PhD · Johnson & Johnson Consumer and Personal Products Worldwide

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00913523 on ClinicalTrials.gov