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Clinical Evaluation of Effects of an Investigational Tampon on Vaginal Microflora

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier:
NCT00913523
First received: June 3, 2009
Last updated: August 19, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Vaginal Microflora
Device: Experimental - Tampon with GML
Device: Sham Control - Tampons without GML

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Vaginal Lactobacillus and Other Key Microflora During and After Menses in Women Using Tampons Containing Glycerol Monolaurate (GML) and Women Using Tampons Without GML

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • Percentage of Subjects Showing Unfavorable Changes in Primary Microflora [ Time Frame: Mid-Cycle Baseline to Mid-Menstrual Samples ] [ Designated as safety issue: No ]
    Percentage of subjects showing unfavorable changes of at least 1-log in lactobacilli (decrease), C. albicans (increase), or G. vaginalis (increase)


Secondary Outcome Measures:
  • Percentage of Subjects Showing Unfavorable Changes in Primary Microflora [ Time Frame: Mid-Cycle Baseline to Post-Menstrual Samples ] [ Designated as safety issue: No ]
    Percentage of subjects showing unfavorable changes of at least 1-log in lactobacilli (decrease), C. albicans (increase), or G. vaginalis (increase)

  • Percentage of Subjects With Selected Microflora in Tampons [ Time Frame: During Menses ] [ Designated as safety issue: No ]
    Percentage of subjects with selected relevant microorganisms in tampons during menses

  • Abundance of Selected Microflora in Tampons [ Time Frame: During Menses ] [ Designated as safety issue: No ]
    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.

  • Changes in Nugent Score [ Time Frame: Mid-Cycle Baseline to Mid-Menstrual Samples ] [ Designated as safety issue: No ]
    Percentage of subjects who showed a change in Nugent score from a score of </= 3 to a score of >/= 4.

  • Changes in Nugent Score [ Time Frame: Mid-Cycle Baseline to Post-Menstrual Samples ] [ Designated as safety issue: No ]
    Percentage of subjects who showed a change in Nugent score from a score of </= 3 to a score of >/= 4.


Enrollment: 482
Study Start Date: January 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Tampons with no 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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00913523

Locations
United States, Arizona
Hill Top Research
Scottsdale, Arizona, United States, 85251
United States, Florida
Hill Top Research
St. Petersburg, Florida, United States, 33710
Sponsors and Collaborators
Johnson & Johnson Consumer and Personal Products Worldwide
Investigators
Study Director: David J Chase, PhD Johnson & Johnson Consumer and Personal Products Worldwide
  More Information

No publications provided

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT00913523     History of Changes
Other Study ID Numbers: 2007-101
Study First Received: June 3, 2009
Results First Received: April 12, 2011
Last Updated: August 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
tampons
Glycerol Monolaurate
vaginal microflora
microbes
Vaginal Tampon

Additional relevant MeSH terms:
Monolaurin
Cariostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on November 24, 2014