N/A
N=482
Clinical Evaluation of Effects of an Investigational Tampon on Vaginal Microflora
Vaginal Microflora
Bottom Line
View on ClinicalTrials.gov: NCT00913523 ↗Enrolled (actual)
482
Serious AEs
0.8%
Results posted
May 2011
Primary outcome: Primary: Percentage of Subjects Showing Unfavorable Changes in Primary Microflora — 52.7; 52.9; 60.0 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Experimental - Tampon with GML (Device); Sham Control - Tampons without GML (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Showing Unfavorable Changes in Primary Microflora |
31.6; 34.3; 36.4 | — |
| SECONDARY Percentage of Subjects Showing Unfavorable Changes in Primary Microflora |
31.6; 34.3; 36.4 | — |
| SECONDARY Percentage of Subjects With Selected Microflora in Tampons |
89.2; 85.0; 85.1; 16.2; 12.1; 19.1 | — |
| SECONDARY Abundance of Selected Microflora in Tampons |
5.5; 6.0; 6.0; 3.3; 3.7; 3.9 | — |
| SECONDARY Changes in Nugent Score |
5.9; 12.9; 10.6 | — |
| SECONDARY Changes in Nugent Score |
5.9; 12.9; 10.6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- normal healthy women
- 18-45 years of age
- regular 21- to 35-day menstrual cycles with at least 5 days of bleeding, or at least 3 days of bleeding if they are using hormonal contraception
- used tampons as their principal mode of menstrual sanitary protection for at least the previous 6 months
- willing to not change their feminine care or hygiene practices during their participation in the study (except as directed by the protocol and instructions for participants)
Exclusion Criteria
- signs or symptoms of clinically significant vulvovaginal infection or vaginosis
- history of recurrent urinary tract or vulvovaginal infection
- abnormal vaginal discharge of any etiology
- use of a systemic, vaginal, or perineal antibiotic, antifungal, anti-infective, or immunosuppressant medication or any experimental drug or medical device within the 30 days preceding the Screening/Baseline Visit
- history of treatment for Toxic Shock Syndrome (TSS) or a suspicion of having had TSS
- other clinical issues or history (per protocol) that would make participation in the trial inappropriate
Data sourced from ClinicalTrials.gov (NCT00913523). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.