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Recruiting

NCT Number: NCT07561905

Tampon Safety-in-Use Study

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.

Recruiting

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Key information

Conditions

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Princeton Consumer Research

St. Petersburg, Florida, 33702, United States

Location status: Recruiting

Location contact

Christine Maraghy

CONTACT

[email protected]

727-576-7300

Christine Maraghy

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tampon A

Device

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

Primary outcomes

  1. Incidence of Tampon Related Adverse Events

    Time frame: From enrollment to 7 days post last visit

    Frequency and severity of tampon related adverse events

Sponsors and collaborators

Lead sponsor

Kimberly-Clark Corporation

Industry

Registry information

Official study title

An Open-Label Applicator Tampon Safety-in-Use Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 1, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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