NCT07561905 · Kimberly-Clark Corporation
Tampon Safety-in-Use Study
What this study is about
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.
View original scientific description
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
Frequency and severity of tampon related adverse events
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- St. Petersburg, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 22, 2026 · Source of record for eligibility and locations