ClinicalTrials.gg
CompletedNCT07561905Updated Sep 23, 2026

Tampon Safety-in-Use Study

An interventional study of Tampon A in Menstruation, sponsored by Kimberly-Clark Corporation. Completed at 1 site in United States. Open to female participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Kimberly-Clark Corporation · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Not applicable
Ages
18 Years to 49 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Menstruation
03

In context

Lead sponsor

Kimberly-Clark Corporation is the lead sponsor of 16 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Eligibility criteria

Key Inclusion Criteria:

  • Willing and able to read and provide written .
  • 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 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 products
  • Any other medical condition or history, as determined by the Investigator that could compromise the study results or subject safety.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    Test Tampon

    Device: Tampon A

Interventions

  • DeviceTampon A

    Commercially available tampons in regular, super, and super plus absorbencies

06

What researchers measure

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 visit

07

Study locations

1 site
  • Princeton Consumer Research
    St. Petersburg, Florida 33702, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2026 to primary completion in Sep 2026, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 24, 2026
First posted
May 1, 2026
StartActual
May 12, 2026
Primary completionActual
Sep 15, 2026
CompletionActual
Sep 16, 2026
Last update
Sep 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07561905
Lead sponsor
Kimberly-Clark Corporation
Responsible party
Sponsor
First posted
May 1, 2026
Start date
May 12, 2026
Primary completion
Sep 15, 2026
Completion
Sep 16, 2026
Last update
Sep 23, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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