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

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

The safety assessment of tampons: illustration of a comprehensive approach for four different products

IntroductionWe illustrate a comprehensive tampon safety assessment approach that assures products can be used safely. Material biocompatibility, vaginal mucosa assessment, vaginal microbiome evaluation, and in vitro assessment of potential risk of staphylococcal toxic shock syndrome expressed through growth of Staphylococcus aureus (S. aureus) and production of TSST-1 are the four essential portions of the approach. Post-marketing surveillance informs of possible health effects that warrant follow up. The approach meets or exceeds US and international regulatory guidance and is described through the example of four tampon products.Methods/ResultsEach product is comprised mostly of large molecular weight components (cotton, rayon, polymers) that cannot pass the vaginal mucosa, are widely used across the industry, and replete with a vast body of safety data and a long history of safe use in the category. Quantitative risk assessment of all small molecular weight components assured a sufficient margin of safety supporting their use. Vaginal mucosa assessment confirmed that pressure points, rough edges and/or sharp contact points were absent. A randomized cross-over clinical trial (ClinicalTrials.gov Identifier: NCT03478371) revealed favorable comfort ratings, and few complaints of irritation, burning, stinging, or discomfort upon insertion, wear, and removal. Adverse events were few, mild in severity, self-limited and resolved without treatment. Vaginal microbiota assessment in vitro presented no adverse effect on microbial growth. Culture-independent microbiome analyses from vaginal swab samples obtained during the clinical trial showed no differences attributable to tampon usage, but instead due to statistically significant subject-to-subject variability. Growth of S. aureus and TSST-1 toxin production in the presence of any of the four products in vitro were statistically significantly reduced when compared to medium control alone.DiscussionThe data from the four elements of the comprehensive safety assessment approach illustrated herein confirm that tampons evaluated using this system can be used safely for menstrual protection. A post-marketing surveillance system that monitors and responds to in-market experiences indicated in-use tolerability of the product among consumers, thus confirming the conclusions of the pre-marketing safety assessment

Inactivation of Coxackievirus B5 with monochloramine

Waterborne pathogens in water sources used for drinking water supply and recreational purposes can have negative health effects on communities in both developed and developing regions of the world. In the United States, the EPA has developed a Drinking Water Contaminant Candidate List including pathogens for potential regulatory action, as they persist in the natural environment and are a threat to public health. One group of pathogens on this list are enteroviruses, of which Coxsackievirus B5 (CVB5), the focus of this study, is a serotype of enterovirus species B that can cause paralysis, myocarditis, and hepatitis. Several disinfectants have been previously considered for the inactivation of a variety of waterborne pathogens. The most common mode of disinfection is free chlorine, which offers the advantage of fast disinfection kinetics. However, using free chlorine also offers the potential to form toxic disinfection by-products (DBPs) such as trihalomethanes and haloacetic acids. Additionally, as free chlorine is relatively reactive, its application could result in low residual disinfectant for the distribution system. In this study, monochloramine is being considered as an alternative disinfectant to free chlorine. Although this form of chlorine is less reactive, and thus, the disinfection kinetics are slower compared to those of free chlorine, it forms lower concentrations of regulated DBPs and under most conditions it provides adequate residual in the distribution system. However, the inactivation kinetics of CVB5 with monochloramine remain to be fully characterized. Accordingly, the main objective of this study was to investigate the inactivation kinetics of CVB5 with monochloramine as a function of pH and temperature within ranges relevant to drinking water treatment. Experiments were performed at all combinations of pH of 7, 8.5, and 10 and temperatures of 5 ̊ C, 15 ̊ C, and 25 ̊ C. Each experimental combination was tested in triplicate and then analyzed using Chick-Watson kinetics. The trends in the data showed that although there was a strong temperature dependence, there was a comparatively limited pH dependence. Additionally, the inactivation data was compared to recommended exposures corresponding to EPA regulations for enteric viruses. Upon analysis, it was determined that the current regulations were generally conservative to represent disinfection kinetics for CVB5.U of I OnlyAuthor requested U of Illinois access only (OA after 2yrs) in Vireo ETD syste