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Infectious Diseases in Obstetrics and Gynecology
Volume 11, Issue 2, Pages 89-99

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

1Procter & Gamble Company, 6110 Center Hill Avenue, Cincinnati 45224, OH, USA
2Arizona School of Health Sciences, Phoenix, AZ, USA
3Hill Top Research, Inc., Scottsdale, AZ, USA

Received 23 September 2002; Accepted 22 April 2003

Copyright © 2003 Hindawi Publishing Corporation. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


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.