Clinical Evaluation of Effects of an Investigational Tampon on Vaginal Microflora

Study Overview
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Brief Summary
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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.

Detailed Description
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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. This study will be a randomized, single-blinded, multi-center study of women using Tampons with GML, Tampons without GML or the Tampons Normally Used for one menstrual period. Subjects will undergo Baseline microflora evaluations taken from the vaginal walls 5-10 days following their menstrual period (Baseline evaluation). Subjects will be randomly assigned to use one of the three study products during their next menstrual period. Microflora will be re-evaluated in samples taken from the tampons and from the vaginal walls during use of the study tampons, and from vaginal walls soon after the end of the menstrual period. Evaluations of microflora will be done by quantitative cultures of tampons and vaginal swabs, and also by Nugent scoring of the vaginal swabs. Staphylococcal α-hemolysin and TSST-1 will be analyzed in extracts of the study tampons from subjects found to be colonized with S. aureus. Vaginal pH will be measured, using electronic meters, at each clinic visit. All samples (tampons and vaginal swabs) will be analyzed at a central microbiology laboratory. Extracts of tampons found to contain S. aureus will be forwarded to another central laboratory for the toxin assays. Personnel in the central laboratories will be blinded to the group assignment (study product) for each subject until completion of the study.

Official Title
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Vaginal Lactobacillus and Other Key Microflora During and After Menses in Women Using Tampons Containing Glycerol Monolaurate (GML) and Women Using Tampons Without GML

Conditions
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Vaginal Microflora

Intervention / Treatment
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* Device: Experimental - Tampon with GML
* Device: Sham Control - Tampons without GML


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tampon with GML<br>Regular and Super Tampon with GML added to the cover | Device: Experimental - Tampon with GML<br>* Regular and Super Tampon with Glycerol Monolaurate (GML) added to the cover<br>* Other names: Not yet marketed;|
| Sham Comparator: Tampon without GML<br>Regular and Super Tampon without GML | Device: Sham Control - Tampons without GML<br>* There is no intervention associated with these arms - they are sham controls.<br>* Other names: Tampons with no GML;|
| Sham Comparator: Tampon Normally Used<br>Type and Size of Tampon Normally Used by Subjects | Device: Sham Control - Tampons without GML<br>* There is no intervention associated with these arms - they are sham controls.<br>* Other names: Tampons with no GML;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Showing Unfavorable Changes in Primary Microflora | Percentage of subjects showing unfavorable changes of at least 1-log in lactobacilli (decrease), C. albicans (increase), or G. vaginalis (increase) | Mid-Cycle Baseline to Mid-Menstrual Samples | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Showing Unfavorable Changes in Primary Microflora | Percentage of subjects showing unfavorable changes of at least 1-log in lactobacilli (decrease), C. albicans (increase), or G. vaginalis (increase) | Mid-Cycle Baseline to Post-Menstrual Samples | 
| Percentage of Subjects With Selected Microflora in Tampons | Percentage of subjects with selected relevant microorganisms in tampons during menses | During Menses | 
| Abundance of Selected Microflora in Tampons | Abundance of selected relevant microorganisms in tampons during menses, in log10 colony forming units (CFU) per gram of menstrual fluid add-on to the tampon, in subjects who had detectable counts of the microorganism. | During Menses | 
| Changes in Nugent Score | Percentage of subjects who showed a change in Nugent score from a score of </= 3 to a score of >/= 4. | Mid-Cycle Baseline to Mid-Menstrual Samples | 
| Changes in Nugent Score | Percentage of subjects who showed a change in Nugent score from a score of </= 3 to a score of >/= 4. | Mid-Cycle Baseline to Post-Menstrual Samples | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tampons, Glycerol Monolaurate, vaginal microflora, microbes, Vaginal Tampon