Clinical Safety-in-Use Study of a New Tampon Design
| Autor: | Stephen Nunn, Anne E. Hochwalt, Michaelle B. Jones, Stacey E. Shehin, Frank C. Sarbaugh |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2003 |
| Předmět: |
Vaginal discharge
Adult medicine.medical_specialty Adolescent Dentistry Dermatology medicine.disease_cause lcsh:Gynecology and obstetrics Introitus lcsh:Infectious and parasitic diseases medicine Subject Diary Humans lcsh:RC109-216 Single-Blind Method Menstrual Hygiene Products Cervix lcsh:RG1-991 Colposcopy Cross-Over Studies medicine.diagnostic_test business.industry Obstetrics and Gynecology Hydrogen-Ion Concentration Middle Aged equipment and supplies Surgery Infectious Diseases medicine.anatomical_structure Vaginal Discharge Mental Recall Vagina Female medicine.symptom Irritation Safety business Tampon Research Article |
| Zdroj: | Infectious Diseases in Obstetrics and Gynecology Infectious Diseases in Obstetrics and Gynecology, Vol 11, Iss 2, Pp 89-99 (2003) |
| ISSN: | 1064-7449 |
| DOI: | 10.1080/10647440300025504 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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