CompletedNCT05553600Updated Jan 17, 2024Results posted

Tampon Design Validation Study

An interventional study of Tampon BR and Tampon CR in Menstruation, sponsored by Kimberly-Clark Corporation. Completed at 9 sites in United States. Open to female participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-17.

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

Phase: Not applicable
Study type: Interventional
Enrollment: 732
Allocation: Randomized
Ages: 18 Years to 49 Years
Sex: Female

Study 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.

Conditions studied

Menstruation

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.

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 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 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, including rayon.
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.

Study design

Phase: Not applicable
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 732 participants (actual)

Study arms

Other
Regular Absorbency
Modified regular absorbency tampon versus regular absorbency reference tampon
Device: Tampon BR · Device: Tampon CR
Other
Super Absorbency
Modified super absorbency tampon versus super absorbency reference tampon
Device: Tampon BS · Device: Tampon CS

Interventions

DeviceTampon BR
Modified Regular Absorbency Tampons
DeviceTampon CR
Reference Regular Absorbency Tampons
DeviceTampon BS
Modified Super Absorbency Tampons
DeviceTampon CS
Reference Super Absorbency Tampons

What researchers measure

Primary outcomes

The Percentage of Used Tampons That Have Elongated
The percentage of used tampons within each test code that have elongated \>10mm. The denominator for the percentage calculation is based upon the number of used tampons returned within each test code.
Time frame: At the end of 1 menstrual period (up to 10 days) for each intervention

Secondary outcomes

Validation of Performance User Needs Based on Participant Diary Responses.
Percentage of participants reporting tampons performed as needed through diary responses. The following responses were solicited once at the end of the menstrual period.
Time frame: At the end of 1 menstrual period (up to 10 days) for each intervention
Validation of Performance User Needs Based on Participant Diary Responses
Percentage of tampons performing as needed. The following diary responses were solicited after every tampon use.
Time frame: At the end of 1 menstrual period (up to 10 days) for each intervention
Validation of Packaging/Labeling User Needs Based on Interview Responses
Proportion of participants able to locate key packaging/labeling information.
Time frame: At baseline, prior to any interventions
Number of Subjects That Had Any Lesions Noted During Gynecological Exam
Number of subjects noted during pre- and post-use gynecological exams that had any lesions by anatomical location
Time frame: Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention
Additional Gynecological Exam Results: Pre-use Vaginal pH
Vaginal pH prior to tampon use.
Time frame: Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention
Additional Gynecological Exam Results: Post-use Vaginal pH
Vaginal pH after tampon use.
Time frame: Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention
Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results
Additional gynecological exam results prior to and following tampon use including: number of participants with suspected infections, other abnormal finding, and exam results that the investigators found clinically significant.
Time frame: Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention

Results

Posted Jan 17, 2024

Participant flow

Prior to First Menstrual Cycle Starting

Participant flow — Prior to First Menstrual Cycle Starting
Milestone	Regular Absorbency: BR, Then CR	Regular Absorbency: CR, Then BR	Super Absorbency: BS, Then CS	Super Absorbency: CS, Then BS
Started	201	203	166	162
Completed	174	173	145	140
Not completed	27	30	21	22
Withdrew: Withdrawal by subject	4	8	6	7
Withdrew: Protocol violation	0	1	0	2
Withdrew: Physician decision	0	0	0	1
Withdrew: Lost to follow-up	16	13	12	10
Withdrew: Other various reasons	7	8	3	2

Prior to Second Menstrual Cycle Starting

Participant flow — Prior to Second Menstrual Cycle Starting
Milestone	Regular Absorbency: BR, Then CR	Regular Absorbency: CR, Then BR	Super Absorbency: BS, Then CS	Super Absorbency: CS, Then BS
Started	174	173	145	140
Completed	156	151	132	121
Not completed	18	22	13	19
Withdrew: Adverse event	0	0	1	0
Withdrew: Withdrawal by subject	2	2	4	1
Withdrew: Protocol violation	1	3	0	1
Withdrew: Physician decision	6	4	1	6
Withdrew: Lost to follow-up	5	6	4	3
Withdrew: Other various reasons	4	7	3	8

After Second Menstrual Cycle Began

Participant flow — After Second Menstrual Cycle Began
Milestone	Regular Absorbency: BR, Then CR	Regular Absorbency: CR, Then BR	Super Absorbency: BS, Then CS	Super Absorbency: CS, Then BS
Started	156	151	132	121
Completed	155	151	132	121
Not completed	1	0	0	0
Withdrew: Adverse event	1	0	0	0

Outcome measures

PrimaryThe Percentage of Used Tampons That Have Elongated

The percentage of used tampons within each test code that have elongated \>10mm. The denominator for the percentage calculation is based upon the number of used tampons returned within each test code.

Time frame:: At the end of 1 menstrual period (up to 10 days) for each intervention
Reported as:: Count of units · tampons

The Percentage of Used Tampons That Have Elongated
tampons	Tampon BR	Tampon CR	Tampon BS	Tampon CS
The Percentage of Used Tampons That Have Elongated	2	75	4	48

SecondaryValidation of Performance User Needs Based on Participant Diary Responses.

Percentage of participants reporting tampons performed as needed through diary responses. The following responses were solicited once at the end of the menstrual period.

Time frame:: At the end of 1 menstrual period (up to 10 days) for each intervention
Reported as:: Count of participants · Participants

Validation of Performance User Needs Based on Participant Diary Responses.
Participants	Tampon BR	Tampon CR	Tampon BS	Tampon CS
Participants reporting they were able to open the box and retrieve the wrapped tampons	322	320	260	266
Participants reporting they were able to open each tampon wrapper	321	319	260	266
Participants reporting tampons were clean prior to use	322	320	260	266
Participants reporting they were able to insert the tampons with applicator	297	295	238	249

SecondaryValidation of Performance User Needs Based on Participant Diary Responses

Percentage of tampons performing as needed. The following diary responses were solicited after every tampon use.

Time frame:: At the end of 1 menstrual period (up to 10 days) for each intervention
Reported as:: Count of units · Tampons

Validation of Performance User Needs Based on Participant Diary Responses
Tampons	Tampon BR	Tampon CR	Tampon BS	Tampon CS
Tampons that remained white when subject was experiencing flow	38	33	43	20
Tampons participants reported they were able to remove	3227	3133	2904	2870

SecondaryValidation of Packaging/Labeling User Needs Based on Interview Responses

Proportion of participants able to locate key packaging/labeling information.

Time frame:: At baseline, prior to any interventions
Reported as:: Count of participants · Participants

Validation of Packaging/Labeling User Needs Based on Interview Responses
Participants	Packaging Interview Group
Able to identify tampon absorbency on regular absorbency box	146
Able to identify tampon absorbency on super absorbency box	146
Able to identify tampon absorbency on super plus absorbency box	146
Able to identify tampon absorbencies on multipack box	139
Able to identify tampon absorbency ranges for entire line on box	147
Able to identify toxic shock syndrome warning on box	147
Able to identify how long a tampon should be used on box	132
Able to identify regular absorbency wrapped tampon	138
Able to identify super absorbency wrapped tampon	140
Able to identify super plus absorbency wrapped tampon	139
Able to identify instructions for use on insert	146
Able to identify toxic shock syndrome information on insert	144

SecondaryNumber of Subjects That Had Any Lesions Noted During Gynecological Exam

Number of subjects noted during pre- and post-use gynecological exams that had any lesions by anatomical location

Time frame:: Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention
Reported as:: Count of participants · Participants

Number of Subjects That Had Any Lesions Noted During Gynecological Exam
Participants	Tampon BR	Tampon CR	Tampon BS	Tampon CS
Perineum : Pre-Use	0	1	0	0
Perineum : Post-Use	1	0	0	0
Vulva : Pre-Use	0	1	1	1
Vulva : Post-Use	0	0	0	2
Urethra : Pre-Use	0	0	0	0
Urethra : Post-Use	0	0	0	0
Vagina : Pre-Use	0	0	0	0
Vagina : Post-Use	0	0	0	0
Cervix : Pre-Use	0	0	0	0
Cervix : Post-Use	0	1	0	0

SecondaryAdditional Gynecological Exam Results: Pre-use Vaginal pH

Vaginal pH prior to tampon use.

Time frame:: Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention
Reported as:: Mean · pH

Additional Gynecological Exam Results: Pre-use Vaginal pH
pH	Tampon BR	Tampon CR	Tampon BS	Tampon CS
Additional Gynecological Exam Results: Pre-use Vaginal pH	4.81 ± 0.436	4.72 ± 0.380	4.99 ± 0.672	5.14 ± 0.805

SecondaryAdditional Gynecological Exam Results: Post-use Vaginal pH

Vaginal pH after tampon use.

Time frame:: Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention
Reported as:: Mean · pH

Additional Gynecological Exam Results: Post-use Vaginal pH
pH	Tampon BR	Tampon CR	Tampon BS	Tampon CS
Additional Gynecological Exam Results: Post-use Vaginal pH	4.85 ± 0.499	4.76 ± 0.412	5.19 ± 0.848	4.86 ± 0.518

SecondaryAdditional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results

Additional gynecological exam results prior to and following tampon use including: number of participants with suspected infections, other abnormal finding, and exam results that the investigators found clinically significant.

Time frame:: Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention
Reported as:: Count of participants · Participants

Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results
Participants	Tampon BR	Tampon CR	Tampon BS	Tampon CS
Suspected Infection : Pre-Use	0	0	1	0
Suspected Infection : Post-Use	6	0	2	1
Other abnormal finding : Pre-Use	0	1	0	0
Other abnormal finding : Post-Use	1	0	0	0
Clinically significant exam results : Pre-Use	0	0	0	0
Clinically significant exam results : Post-Use	5	0	1	0

Adverse events

Collected over Through study completion, an average of 2 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Tampon BR	0/323 (0%)	1/323 (0.3%)	0/323 (0%)
Tampon CR	0/323 (0%)	0/323 (0%)	0/323 (0%)
Tampon BS	0/263 (0%)	0/263 (0%)	0/263 (0%)
Tampon CS	0/268 (0%)	0/268 (0%)	0/268 (0%)

Most frequent serious events

Most frequent serious events
Event	Tampon BR	Tampon CR	Tampon BS	Tampon CS
COVID-19Infections and infestations	1/323	0/323	0/263	0/268

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Regular Absorbency	Super Absorbency	Total
Mean	32.8 ± 8.11	34.6 ± 7.62	33.6 ± 7.94

Sex: Female, Male
Sex: Female, Male(Participants)	Regular Absorbency	Super Absorbency	Total
Female	404	328	732
Male	0	0	0

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Regular Absorbency	Super Absorbency	Total
Hispanic or Latino	81	56	137
Not Hispanic or Latino	318	264	582
Unknown or Not Reported	5	8	13

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Regular Absorbency	Super Absorbency	Total
American Indian or Alaska Native	1	3	4
Asian	17	10	27
Native Hawaiian or Other Pacific Islander	0	1	1
Black or African American	115	123	238
White	264	185	449
More than one race	2	4	6
Unknown or Not Reported	5	2	7

Study locations

9 sites

Del Sol Research Management, LLC
Tucson, Arizona 85715, United States
Agile Clinical Research Trials, LLC
Atlanta, Georgia 30328, United States
Velocity Clinical Research
Boise, Idaho 83642, United States
Best Clinical Trials, LLC
New Orleans, Louisiana 70115, United States
Princeton Consumer Research
Raritan, New Jersey 08869, United States
Velocity Clinical Research
Anderson, South Carolina 29621, United States
Velocity Clinical Research
Greenville, South Carolina 29615, United States
Signature Gyn Services
Fort Worth, Texas 76104, United States
TMC Life Research, Inc.
Houston, Texas 77054, United States

References and documents

Study documents

Study protocol ↗ · Aug 24, 2022
Statistical analysis plan ↗ · Jun 5, 2023

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2022 to primary completion in May 2023, 6 months.

Results were first posted in Jan 2024, 8 months after primary completion.

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

Registered: Sep 16, 2022
First posted: Sep 23, 2022
StartActual: Oct 21, 2022
Primary completionActual: May 5, 2023
CompletionActual: May 5, 2023
Results first posted: Jan 17, 2024
Last update: Jan 17, 2024

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 Jan 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05553600
Lead sponsor: Kimberly-Clark Corporation
Responsible party: Sponsor
First posted: Sep 23, 2022
Start date: Oct 21, 2022
Primary completion: May 5, 2023
Completion: May 5, 2023
Results posted: Jan 17, 2024
Last update: Jan 17, 2024

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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