Safety Study of a New Tampon Design
Author Information
Author(s): Stacey E. Shehin, Michaelle B. Jones, Anne E. Hochwalt, Frank C. Sarbaugh, Stephen Nunn
Primary Institution: Procter & Gamble Company
Hypothesis
The new experimental Tampax tampon and applicator are as safe as the currently marketed Tampax tampon and applicator.
Conclusion
The study found no significant differences in safety profiles between the new and currently marketed tampons.
Supporting Evidence
- The study involved 110 women who completed the safety assessments.
- There were no significant differences in the prevalence of selected microorganisms between the two tampon types.
- Both tampons had similar low incidences of reported symptoms during use.
- The experimental tampon received a more favorable overall product rating.
Takeaway
This study tested a new tampon to see if it was safe to use, and it turned out to be just as safe as the old one.
Methodology
A 2-month, single-blind, randomized, crossover study where each subject served as her own control, evaluating safety through gynecological and microbiological assessments.
Limitations
Some subjects were not evaluable for statistical analyses due to non-compliance with the protocol.
Participant Demographics
Healthy adult women aged 18-45, mostly Caucasian (94%).
Statistical Information
P-Value
0.003
Statistical Significance
p = 0.003
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