Clinical Evaluation of Effects of an Investigational Tampon on Vaginal Microflora

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

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.

Study Overview

• Status: Completed
• Conditions: Vaginal Microflora
• Intervention / Treatment: Device: Experimental - Tampon with GML; Device: Sham Control - Tampons without GML

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 482
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85251
      • Hill Top Research
  • Florida
    • St. Petersburg, Florida, United States, 33710
      • Hill Top Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
• Investigators: Study Director: David J Chase, PhD, Johnson & Johnson Consumer and Personal Products Worldwide

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: June 3, 2009
• First Submitted That Met QC Criteria: June 3, 2009
• First Posted (Estimate): June 4, 2009

Study Record Updates

• Last Update Posted (Estimate): August 23, 2011
• Last Update Submitted That Met QC Criteria: August 19, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: tampons; Glycerol Monolaurate; vaginal microflora; microbes; Vaginal Tampon
• Other Study ID Numbers: 2007-101