Menstruation
Conditions
Brief 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.
Interventions
DEVICETampon A
Commercially available tampons in regular, super, and super plus absorbencies
Sponsors
Kimberly-Clark Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
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, super, and/or super plus absorbency tampons for menstrual protection. * Agrees to the conduct of all study procedures, including gynecological exams and agrees to follow all study instructions and return for scheduled appointments. * Has used an acceptable form of birth control for at least one month prior to enrollment and for the duration of the study. Key
Exclusion criteria
* 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 * Any other medical condition or history, as determined by the Investigator that could compromise the study results or subject safety.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Tampon Related Adverse Events | From enrollment to 7 days post last visit | Frequency and severity of tampon related adverse events |
Countries
United States
Outcome results
None listed