Clinical Safety-in-Use Study of a New Tampon Design

摘要

Objective:To confirm the safety of a new experimental Tampax?tampon and applicator compared with thatof a currently marketed Tampax?tampon and applicator using comprehensive gynecological and microbiologicalassessments.Methods:A 2-month, single-blind, randomized, crossover study was conducted in which each subject servedas her own control. Safety was evaluated by comparing potential product-related irritation (using colposcopicexamination and subject diary data), assessment of vaginal discharge, vaginal pH, and effects on selected microorganisms(yeast,Escherichia coli,Staphylococcus aureusand group B streptococci) obtained by vaginal swabcultures after normal menstrual use in the experimental and control groups.Results:In total, 110 women completed the study. There were no significant differences between the groupsthat used either the experimental or control tampon with regard to prevalence or mean cell density for theselected microorganisms. No differences were observed in the incidence or severity of erythema, in abrasionor ulceration of the cervix, vagina, introitus, vulva or perineum, or in mean vaginal pH and discharge assessments.There were equivalent low incidences of reported symptoms such as discomfort during insertion, wear or removal,and a similar low incidence of burning, stinging or itching during use of either the control or experimental tampon.There was a more favorable overall product rating for the experimental tampon (p= 0.003).Conclusions:This approach provides a combination of gynecological, microbiological and self-reported (diaryrecall) methodologies in order to assess tampon safety during use more thoroughly than has previously beenreported, and it supports a comparable safety profile for the experimental tampon and a currently marketedtampon.