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
This trial accepts healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Tampon A
DeviceCommercially available tampons in regular, super, and super plus absorbencies
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Test TamponExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Tampon Related Adverse Events
Frequency and severity of tampon related adverse events
Time frame
From enrollment to 7 days post last visitSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov