Safety Study of an Applicator Tampon in Healthy Women Ages 18 to 49

What this Trial Is About

This clinical trial evaluates the safety of a commercially available tampon in healthy females aged 18 to 49 who have regular menstrual cycles. The study focuses on confirming the safety profile of tampons in normal use during one menstrual cycle. Participants are expected to have a history of tampon use without discomfort and to follow study procedures including gynecological exams. Participants will use the test tampon, available in regular, super, and super plus absorbencies, as they normally would throughout one menstrual cycle. The study is open-label, meaning all participants use the test tampon without comparison to placebo or other products. Gynecological examinations will be performed before and after the menstrual cycle to monitor safety. During the study, participants will attend scheduled visits for exams and follow instructions to track menstruation and tampon use. Researchers will measure the incidence of tampon-related adverse events from enrollment through seven days after the last visit. The total participation period covers one menstrual cycle with safety monitoring continuing shortly after tampon use ends.

Tampon Safety-in-Use Study