Clinical trial NCT05553600: Tampon Design Validation Study
Official title: An Open-Label Clinical Validation Study of an Applicator Tampon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menstruation
Lead sponsor: Kimberly-Clark Corporation
Sponsor class: INDUSTRY
First posted: 2022-09-23
Enrollment: 732
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This prospective multi-center, open-label, randomized, cross-over study is designed to validate the user needs of a tampon design. The hypothesis is that user needs are met.


Eligibility criteria: 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 without discomfort.
* 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 (if applicable), 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, including rayon.
* Any other medical condition or history, as determined by the Investigator that could compromise the study results or subject safety.

Primary outcomes:
measure: The Percentage of Used Tampons That Have Elongated
timeFrame: At the end of 1 menstrual period (up to 10 days) for each intervention
Secondary outcomes:
measure: Validation of Performance User Needs Based on Participant Diary Responses.
timeFrame: At the end of 1 menstrual period (up to 10 days) for each intervention
measure: Validation of Performance User Needs Based on Participant Diary Responses
timeFrame: At the end of 1 menstrual period (up to 10 days) for each intervention
measure: Validation of Packaging/Labeling User Needs Based on Interview Responses
timeFrame: At baseline, prior to any interventions
measure: Number of Subjects That Had Any Lesions Noted During Gynecological Exam
timeFrame: Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention
measure: Additional Gynecological Exam Results: Pre-use Vaginal pH
timeFrame: Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention
measure: Additional Gynecological Exam Results: Post-use Vaginal pH
timeFrame: Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention
measure: Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results
timeFrame: Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Del Sol Research Management, LLC
state: Arizona
city: Atlanta
country: United States
facility: Agile Clinical Research Trials, LLC
state: Georgia
city: Boise
country: United States
facility: Velocity Clinical Research
state: Idaho
city: New Orleans
country: United States
facility: Best Clinical Trials, LLC
state: Louisiana
city: Raritan
country: United States
facility: Princeton Consumer Research
state: New Jersey
city: Anderson
country: United States
facility: Velocity Clinical Research
state: South Carolina
city: Greenville
country: United States
facility: Velocity Clinical Research
state: South Carolina
city: Fort Worth
country: United States
facility: Signature Gyn Services
state: Texas
city: Houston
country: United States
facility: TMC Life Research, Inc.
state: Texas
Study officials:
References: