Recruiting NCT07561905
Tampon Safety-in-Use Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tampon A.
- Who it may be relevant to
- Registry conditions: Menstruation. Basic parameters: 18 years — 49 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-Label Applicator Tampon Safety-in-Use Study
Overview
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
- Device Tampon A
Commercially available tampons in regular, super, and super plus absorbencies
Primary outcome measures
- Incidence of Tampon Related Adverse Events [Time frame: From enrollment to 7 days post last visit]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Princeton Consumer Research — St. Petersburg
Identifiers
NCT: NCT07561905 · CNS-2026-0003