Tampon Safety-in-Use Study
ConditionMenstruation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-49
SponsorKimberly-Clark Corporation
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Pregnant, lactating or is trying to become pregnant.
Less than six (6) weeks post-partum.
Has a menstrual abnormality (such as oligomenorrhea or amenorrhea).
Has a known allergy or sensitivity to components of the investigational products
Trial design
Treatments tested in this trial
- Tampon A
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov