Toxinok tsst 1
A total 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.
Részletes leírás 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. Subjects will undergo Baseline pinworms, amint eltűnnek evaluations taken from the vaginal walls 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 toxinok tsst 1 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.
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.
Personnel in the central laboratories will be blinded to the group assignment study product for each subject until completion of the study. Átfogó állapot.