An Open-Label Applicator Tampon Safety-in-Use Study
Kimberly-Clark Corporation
Summary
The goal of this clinical trial is to confirm the safety of a tampon in healthy female volunteers. Participants will use the study tampons as they normally would for one menstrual cycle. Gynecological exams will be conducted before and after the menstrual cycle.
Eligibility
- Age range
- 18–49 years
- Sex
- Female
- Healthy volunteers
- Yes
Key Inclusion Criteria: * Willing and able to read and provide written informed consent. * Female in good general health, age 18-49 (inclusive). * History of regular menstrual cycles during the previous 3months lasting approximately 21-35 days, including at least 4 days of menstruation, and expecting to menstruate during the study period. * History of use of applicator tampons within the past 12 months without discomfort. * Tracks menstruation and be able to confidently predict onset of menstruation * Normally use at least 6 tampons for protection during menstruation. * Normally uses regular,…
Interventions
- DeviceTampon A
Commercially available tampons in regular, super, and super plus absorbencies
Location
- Princeton Consumer ResearchSt. Petersburg, Florida