Clinical Evaluation of Effects of an Investigational Tampon on Vaginal Microflora
Condition: Vaginal Microflora
Study type: Interventional

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.
    

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.
    

Intervention name(s): Experimental - Tampon with GML; Sham Control - Tampons without GML
Intervention type(s): Device; Device
Intervention description(s): Regular and Super Tampon with Glycerol Monolaurate (GML) added to the cover; There is no intervention associated with these arms - they are sham controls.
Other intervention name(s): Not yet marketed; Tampons with no GML
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: tampons; Glycerol Monolaurate; vaginal microflora; microbes; Vaginal Tampon