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. 2003;11(2):89–99. doi: 10.1080/10647440300025504

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

Stacey E Shehin 1,✉, Michaelle B Jones 1, Anne E Hochwalt 1, Frank C Sarbaugh 1, Stephen Nunn 2,3
PMCID: PMC1852271  PMID: 14627214

Abstract

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.

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Selected References

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  1. Barrett K. F., Bledsoe S., Greer B. E., Droegemueller W. Tampon-induced vaginal or cervical ulceration. Am J Obstet Gynecol. 1977 Feb 1;127(3):332–333. doi: 10.1016/0002-9378(77)90483-5. [DOI] [PubMed] [Google Scholar]
  2. Berkeley A. S., Micha J. P., Freedman K. S., Hirsch J. C. The potential of digitally inserted tampons to induce vaginal lesions. Obstet Gynecol. 1985 Jul;66(1):31–35. [PubMed] [Google Scholar]
  3. Chow A. W., Bartlett K. H., Percival-Smith R., Morrison B. J. Vaginal colonization with Staphylococcus aureus, positive for toxic-shock marker protein, and Escherichia coli in healthy women. J Infect Dis. 1984 Jul;150(1):80–84. doi: 10.1093/infdis/150.1.80. [DOI] [PubMed] [Google Scholar]
  4. Chow A. W., Percival-Smith R., Bartlett K. H., Goldring A. M., Morrison B. J. Vaginal colonization with Escherichia coli in healthy women. Determination of relative risks by quantitative culture and multivariate statistical analysis. Am J Obstet Gynecol. 1986 Jan;154(1):120–126. doi: 10.1016/0002-9378(86)90406-0. [DOI] [PubMed] [Google Scholar]
  5. Danielson R. W. Vaginal ulcers caused by tampons. Am J Obstet Gynecol. 1983 Jul 1;146(5):547–549. doi: 10.1016/0002-9378(83)90799-8. [DOI] [PubMed] [Google Scholar]
  6. Fraser I. S., Lähteenmäki P., Elomaa K., Lacarra M., Mishell D. R., Jr, Alvarez F., Brache V., Weisberg E., Hickey M., Vallentine P. Variations in vaginal epithelial surface appearance determined by colposcopic inspection in healthy, sexually active women. Hum Reprod. 1999 Aug;14(8):1974–1978. doi: 10.1093/humrep/14.8.1974. [DOI] [PubMed] [Google Scholar]
  7. Friedrich E. G., Jr, Siegesmund K. A. Tampon-associated vaginal ulcerations. Obstet Gynecol. 1980 Feb;55(2):149–156. [PubMed] [Google Scholar]
  8. Kjaergaar S. K., Hodgson M. The assessment of irritation using clinical methods and questionnaires. AIHAJ. 2001 Nov-Dec;62(6):711–716. doi: 10.1080/15298660108984679. [DOI] [PubMed] [Google Scholar]
  9. Martin R. R., Buttram V., Besch P., Kirkland J. J., Petty G. P. Nasal and vaginal Staphylococcus aureus in young women: quantitative studies. Ann Intern Med. 1982 Jun;96(6 Pt 2):951–953. doi: 10.7326/0003-4819-96-6-951. [DOI] [PubMed] [Google Scholar]
  10. Morris C. A., Morris D. F. Normal vaginal microbiology of women of childbearing age in relation to the use of oral contraceptives and vaginal tampons. J Clin Pathol. 1967 Jul;20(4):636–640. doi: 10.1136/jcp.20.4.636. [DOI] [PMC free article] [PubMed] [Google Scholar]
  11. Onderdonk A. B., Zamarchi G. R., Rodriguez M. L., Hirsch M. L., Muñoz A., Kass E. H. Qualitative assessment of vaginal microflora during use of tampons of various compositions. Appl Environ Microbiol. 1987 Dec;53(12):2779–2784. doi: 10.1128/aem.53.12.2779-2784.1987. [DOI] [PMC free article] [PubMed] [Google Scholar]
  12. Onderdonk A. B., Zamarchi G. R., Rodriguez M. L., Hirsch M. L., Muñoz A., Kass E. H. Quantitative assessment of vaginal microflora during use of tampons of various compositions. Appl Environ Microbiol. 1987 Dec;53(12):2774–2778. doi: 10.1128/aem.53.12.2774-2778.1987. [DOI] [PMC free article] [PubMed] [Google Scholar]
  13. Onderdonk A. B., Zamarchi G. R., Walsh J. A., Mellor R. D., Muñoz A., Kass E. H. Methods for quantitative and qualitative evaluation of vaginal microflora during menstruation. Appl Environ Microbiol. 1986 Feb;51(2):333–339. doi: 10.1128/aem.51.2.333-339.1986. [DOI] [PMC free article] [PubMed] [Google Scholar]
  14. Persson K., Bjerre B., Hansson H., Forsgren A. Several factors influencing the colonization of group B streptococci--rectum probably the main reservoir. Scand J Infect Dis. 1981;13(3):171–175. doi: 10.3109/inf.1981.13.issue-3.03. [DOI] [PubMed] [Google Scholar]
  15. Raudrant D., Landrivon G., Frappart L., De Haas P., Champion F., Ecochard R. Comparison of the effects of different menstrual tampons on the vaginal epithelium: a randomised clinical trial. Eur J Obstet Gynecol Reprod Biol. 1995 Jan;58(1):41–46. doi: 10.1016/0028-2243(94)01977-f. [DOI] [PubMed] [Google Scholar]
  16. Robinson M. K., Perkins M. A. Evaluation of a quantitative clinical method for assessment of sensory skin irritation. Contact Dermatitis. 2001 Oct;45(4):205–213. doi: 10.1034/j.1600-0536.2001.450403.x. [DOI] [PubMed] [Google Scholar]
  17. Shaw C., Matthews R. J., Perry S. I., Assassa R. P., Williams K., McGrother C., Dallosso H., Jagger C., Mayne C., Clarke M. Validity and reliability of an interviewer-administered questionnaire to measure the severity of lower urinary tract symptoms of storage abnormality: the Leicester Urinary Symptom Questionnaire. BJU Int. 2002 Aug;90(3):205–215. doi: 10.1046/j.1464-410x.2002.02893.x. [DOI] [PubMed] [Google Scholar]
  18. Smith C. B., Noble V., Bensch R., Ahlin P. A., Jacobson J. A., Latham R. H. Bacterial flora of the vagina during the menstrual cycle: findings in users of tampons, napkins, and sea sponges. Ann Intern Med. 1982 Jun;96(6 Pt 2):948–951. doi: 10.7326/0003-4819-96-6-948. [DOI] [PubMed] [Google Scholar]
  19. Wagner G., Ottesen B. Vaginal physiology during menstruation. Ann Intern Med. 1982 Jun;96(6 Pt 2):921–923. doi: 10.7326/0003-4819-96-6-921. [DOI] [PubMed] [Google Scholar]

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