Objective: To confirm the safety of a new experimental Tampax® tampon and applicator compared with that
of a currently marketed Tampax®
tampon and applicator using comprehensive gynecological and microbiological
assessments.Methods: A 2-month, single-blind, randomized, crossover study was conducted in which each subject served
as her own control. Safety was evaluated by comparing potential product-related irritation (using colposcopic
examination and subject diary data), assessment of vaginal discharge, vaginal pH, and effects on selected microorganisms
(yeast, Escherichia coli ,Staphylococcus aureus and group B streptococci) obtained by vaginal swab
cultures 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 groups
that used either the experimental or control tampon with regard to prevalence or mean cell density for the
selected microorganisms. No differences were observed in the incidence or severity of erythema, in abrasion
or 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 (diary
recall) methodologies in order to assess tampon safety during use more thoroughly than has previously been
reported, and it supports a comparable safety profile for the experimental tampon and a currently marketed
tampon.
