NCT07561905CompletedNot Applicable
An Open-Label Applicator Tampon Safety-in-Use Study
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Kimberly-Clark Corporation
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Incidence of Tampon Related Adverse Events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 49 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
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.
Arms & Interventions
Test Tampon
Experimental
Intervention: Tampon A (Device)
Outcomes
Primary Outcomes
Incidence of Tampon Related Adverse Events
Time Frame: From enrollment to 7 days post last visit
Frequency and severity of tampon related adverse events
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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