Menstruation
Conditions
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.
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
Sponsors
Kimberly-Clark Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Used Tampons That Have Elongated | At the end of 1 menstrual period (up to 10 days) for each intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Validation of Performance User Needs Based on Participant Diary Responses. | At the end of 1 menstrual period (up to 10 days) for each intervention | Percentage of participants reporting tampons performed as needed through diary responses. The following responses were solicited once at the end of the menstrual period. |
| Validation of Performance User Needs Based on Participant Diary Responses | At the end of 1 menstrual period (up to 10 days) for each intervention | Percentage of tampons performing as needed. The following diary responses were solicited after every tampon use. |
| Validation of Packaging/Labeling User Needs Based on Interview Responses | At baseline, prior to any interventions | Proportion of participants able to locate key packaging/labeling information. |
| Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention | Number of subjects noted during pre- and post-use gynecological exams that had any lesions by anatomical location |
| Additional Gynecological Exam Results: Pre-use Vaginal pH | Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention | Vaginal pH prior to tampon use. |
| Additional Gynecological Exam Results: Post-use Vaginal pH | Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention | Vaginal pH after tampon use. |
| Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results | 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 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. |
Countries
United States
Participant flow
Pre-assignment details
All 732 subjects enrolled were assigned to a study arm.
Participants by arm
| Arm | Count |
|---|---|
| Regular Absorbency Modified regular absorbency tampon versus regular absorbency reference tampon
Tampon BR: Modified Regular Absorbency Tampons
Tampon CR: Reference Regular Absorbency Tampons | 404 |
| Super Absorbency Modified super absorbency tampon versus super absorbency reference tampon
Tampon BS: Modified Super Absorbency Tampons
Tampon CS: Reference Super Absorbency Tampons | 328 |
| Total | 732 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| After Second Menstrual Cycle Began | Adverse Event | 1 | 0 | 0 | 0 |
| Prior to First Menstrual Cycle Starting | Lost to Follow-up | 16 | 13 | 12 | 10 |
| Prior to First Menstrual Cycle Starting | Other various reasons | 7 | 8 | 3 | 2 |
| Prior to First Menstrual Cycle Starting | Physician Decision | 0 | 0 | 0 | 1 |
| Prior to First Menstrual Cycle Starting | Protocol Violation | 0 | 1 | 0 | 2 |
| Prior to First Menstrual Cycle Starting | Withdrawal by Subject | 4 | 8 | 6 | 7 |
| Prior to Second Menstrual Cycle Starting | Adverse Event | 0 | 0 | 1 | 0 |
| Prior to Second Menstrual Cycle Starting | Lost to Follow-up | 5 | 6 | 4 | 3 |
| Prior to Second Menstrual Cycle Starting | Other various reasons | 4 | 7 | 3 | 8 |
| Prior to Second Menstrual Cycle Starting | Physician Decision | 6 | 4 | 1 | 6 |
| Prior to Second Menstrual Cycle Starting | Protocol Violation | 1 | 3 | 0 | 1 |
| Prior to Second Menstrual Cycle Starting | Withdrawal by Subject | 2 | 2 | 4 | 1 |
Baseline characteristics
| Characteristic | Super Absorbency | Total | Regular Absorbency |
|---|---|---|---|
| Age, Continuous | 34.6 years STANDARD_DEVIATION 7.62 | 33.6 years STANDARD_DEVIATION 7.94 | 32.8 years STANDARD_DEVIATION 8.11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 56 Participants | 137 Participants | 81 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 264 Participants | 582 Participants | 318 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants | 13 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 27 Participants | 17 Participants |
| Race (NIH/OMB) Black or African American | 123 Participants | 238 Participants | 115 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 7 Participants | 5 Participants |
| Race (NIH/OMB) White | 185 Participants | 449 Participants | 264 Participants |
| Sex: Female, Male Female | 328 Participants | 732 Participants | 404 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 323 | 0 / 323 | 0 / 263 | 0 / 268 |
| other Total, other adverse events | 0 / 323 | 0 / 323 | 0 / 263 | 0 / 268 |
| serious Total, serious adverse events | 1 / 323 | 0 / 323 | 0 / 263 | 0 / 268 |
Outcome results
Primary
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
Population: All subjects who have no major protocol deviations and return at least 1 tampon that can be assessed for elongation.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Tampon BR | The Percentage of Used Tampons That Have Elongated | 2 tampons |
| Tampon CR | The Percentage of Used Tampons That Have Elongated | 75 tampons |
| Tampon BS | The Percentage of Used Tampons That Have Elongated | 4 tampons |
| Tampon CS | The Percentage of Used Tampons That Have Elongated | 48 tampons |
Secondary
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
Population: All subjects randomized into the study and participating in the gynecological exam subset.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tampon BR | Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results | Suspected Infection : Pre-Use | 0 Participants |
| Tampon BR | Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results | Suspected Infection : Post-Use | 6 Participants |
| Tampon BR | Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results | Other abnormal finding : Pre-Use | 0 Participants |
| Tampon BR | Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results | Other abnormal finding : Post-Use | 1 Participants |
| Tampon BR | Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results | Clinically significant exam results : Pre-Use | 0 Participants |
| Tampon BR | Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results | Clinically significant exam results : Post-Use | 5 Participants |
| Tampon CR | Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results | Clinically significant exam results : Post-Use | 0 Participants |
| Tampon CR | Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results | Other abnormal finding : Post-Use | 0 Participants |
| Tampon CR | Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results | Suspected Infection : Pre-Use | 0 Participants |
| Tampon CR | Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results | Other abnormal finding : Pre-Use | 1 Participants |
| Tampon CR | Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results | Suspected Infection : Post-Use | 0 Participants |
| Tampon CR | Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results | Clinically significant exam results : Pre-Use | 0 Participants |
| Tampon BS | Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results | Suspected Infection : Post-Use | 2 Participants |
| Tampon BS | Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results | Other abnormal finding : Pre-Use | 0 Participants |
| Tampon BS | Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results | Other abnormal finding : Post-Use | 0 Participants |
| Tampon BS | Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results | Clinically significant exam results : Post-Use | 1 Participants |
| Tampon BS | Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results | Clinically significant exam results : Pre-Use | 0 Participants |
| Tampon BS | Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results | Suspected Infection : Pre-Use | 1 Participants |
| Tampon CS | Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results | Clinically significant exam results : Pre-Use | 0 Participants |
| Tampon CS | Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results | Clinically significant exam results : Post-Use | 0 Participants |
| Tampon CS | Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results | Suspected Infection : Post-Use | 1 Participants |
| Tampon CS | Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results | Other abnormal finding : Post-Use | 0 Participants |
| Tampon CS | Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results | Suspected Infection : Pre-Use | 0 Participants |
| Tampon CS | Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results | Other abnormal finding : Pre-Use | 0 Participants |
Secondary
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
Population: All subjects randomized into the study and participating in the gynecological exam subset that had post-use pH readings.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tampon BR | Additional Gynecological Exam Results: Post-use Vaginal pH | 4.85 pH | Standard Deviation 0.499 |
| Tampon CR | Additional Gynecological Exam Results: Post-use Vaginal pH | 4.76 pH | Standard Deviation 0.412 |
| Tampon BS | Additional Gynecological Exam Results: Post-use Vaginal pH | 5.19 pH | Standard Deviation 0.848 |
| Tampon CS | Additional Gynecological Exam Results: Post-use Vaginal pH | 4.86 pH | Standard Deviation 0.518 |
Secondary
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
Population: All subjects randomized into the study and participating in the gynecological exam subset that had pre-use pH readings.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tampon BR | Additional Gynecological Exam Results: Pre-use Vaginal pH | 4.81 pH | Standard Deviation 0.436 |
| Tampon CR | Additional Gynecological Exam Results: Pre-use Vaginal pH | 4.72 pH | Standard Deviation 0.38 |
| Tampon BS | Additional Gynecological Exam Results: Pre-use Vaginal pH | 4.99 pH | Standard Deviation 0.672 |
| Tampon CS | Additional Gynecological Exam Results: Pre-use Vaginal pH | 5.14 pH | Standard Deviation 0.805 |
Secondary
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
Population: All subjects randomized into the study and participating in the gynecological exam subset.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tampon BR | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Perineum : Pre-Use | 0 Participants |
| Tampon BR | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Perineum : Post-Use | 1 Participants |
| Tampon BR | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Vulva : Pre-Use | 0 Participants |
| Tampon BR | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Vulva : Post-Use | 0 Participants |
| Tampon BR | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Urethra : Pre-Use | 0 Participants |
| Tampon BR | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Urethra : Post-Use | 0 Participants |
| Tampon BR | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Vagina : Pre-Use | 0 Participants |
| Tampon BR | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Vagina : Post-Use | 0 Participants |
| Tampon BR | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Cervix : Pre-Use | 0 Participants |
| Tampon BR | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Cervix : Post-Use | 0 Participants |
| Tampon CR | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Vulva : Pre-Use | 1 Participants |
| Tampon CR | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Cervix : Pre-Use | 0 Participants |
| Tampon CR | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Vulva : Post-Use | 0 Participants |
| Tampon CR | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Urethra : Pre-Use | 0 Participants |
| Tampon CR | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Urethra : Post-Use | 0 Participants |
| Tampon CR | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Vagina : Pre-Use | 0 Participants |
| Tampon CR | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Cervix : Post-Use | 1 Participants |
| Tampon CR | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Vagina : Post-Use | 0 Participants |
| Tampon CR | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Perineum : Pre-Use | 1 Participants |
| Tampon CR | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Perineum : Post-Use | 0 Participants |
| Tampon BS | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Vagina : Post-Use | 0 Participants |
| Tampon BS | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Vagina : Pre-Use | 0 Participants |
| Tampon BS | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Cervix : Post-Use | 0 Participants |
| Tampon BS | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Perineum : Pre-Use | 0 Participants |
| Tampon BS | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Vulva : Post-Use | 0 Participants |
| Tampon BS | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Urethra : Post-Use | 0 Participants |
| Tampon BS | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Cervix : Pre-Use | 0 Participants |
| Tampon BS | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Perineum : Post-Use | 0 Participants |
| Tampon BS | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Urethra : Pre-Use | 0 Participants |
| Tampon BS | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Vulva : Pre-Use | 1 Participants |
| Tampon CS | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Urethra : Pre-Use | 0 Participants |
| Tampon CS | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Vagina : Post-Use | 0 Participants |
| Tampon CS | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Urethra : Post-Use | 0 Participants |
| Tampon CS | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Cervix : Post-Use | 0 Participants |
| Tampon CS | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Vagina : Pre-Use | 0 Participants |
| Tampon CS | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Perineum : Post-Use | 0 Participants |
| Tampon CS | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Vulva : Pre-Use | 1 Participants |
| Tampon CS | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Vulva : Post-Use | 2 Participants |
| Tampon CS | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Perineum : Pre-Use | 0 Participants |
| Tampon CS | Number of Subjects That Had Any Lesions Noted During Gynecological Exam | Cervix : Pre-Use | 0 Participants |
Secondary
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
Population: All subjects randomized into the study and the gynecological exam subset. Packaging interview was conducted at the baseline visit, independent of and prior to any intervention. Therefore, results are broken out by study arm. Responses for some questions were not recorded for all subjects due to protocol deviations.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tampon BR | Validation of Packaging/Labeling User Needs Based on Interview Responses | Able to identify tampon absorbency on regular absorbency box | 146 Participants |
| Tampon BR | Validation of Packaging/Labeling User Needs Based on Interview Responses | Able to identify tampon absorbency on super absorbency box | 146 Participants |
| Tampon BR | Validation of Packaging/Labeling User Needs Based on Interview Responses | Able to identify tampon absorbency on super plus absorbency box | 146 Participants |
| Tampon BR | Validation of Packaging/Labeling User Needs Based on Interview Responses | Able to identify tampon absorbencies on multipack box | 139 Participants |
| Tampon BR | Validation of Packaging/Labeling User Needs Based on Interview Responses | Able to identify tampon absorbency ranges for entire line on box | 147 Participants |
| Tampon BR | Validation of Packaging/Labeling User Needs Based on Interview Responses | Able to identify toxic shock syndrome warning on box | 147 Participants |
| Tampon BR | Validation of Packaging/Labeling User Needs Based on Interview Responses | Able to identify how long a tampon should be used on box | 132 Participants |
| Tampon BR | Validation of Packaging/Labeling User Needs Based on Interview Responses | Able to identify regular absorbency wrapped tampon | 138 Participants |
| Tampon BR | Validation of Packaging/Labeling User Needs Based on Interview Responses | Able to identify super absorbency wrapped tampon | 140 Participants |
| Tampon BR | Validation of Packaging/Labeling User Needs Based on Interview Responses | Able to identify super plus absorbency wrapped tampon | 139 Participants |
| Tampon BR | Validation of Packaging/Labeling User Needs Based on Interview Responses | Able to identify instructions for use on insert | 146 Participants |
| Tampon BR | Validation of Packaging/Labeling User Needs Based on Interview Responses | Able to identify toxic shock syndrome information on insert | 144 Participants |
Secondary
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
Population: All subjects randomized into the study
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Tampon BR | Validation of Performance User Needs Based on Participant Diary Responses | Tampons that remained white when subject was experiencing flow | 38 Tampons |
| Tampon BR | Validation of Performance User Needs Based on Participant Diary Responses | Tampons participants reported they were able to remove | 3227 Tampons |
| Tampon CR | Validation of Performance User Needs Based on Participant Diary Responses | Tampons participants reported they were able to remove | 3133 Tampons |
| Tampon CR | Validation of Performance User Needs Based on Participant Diary Responses | Tampons that remained white when subject was experiencing flow | 33 Tampons |
| Tampon BS | Validation of Performance User Needs Based on Participant Diary Responses | Tampons that remained white when subject was experiencing flow | 43 Tampons |
| Tampon BS | Validation of Performance User Needs Based on Participant Diary Responses | Tampons participants reported they were able to remove | 2904 Tampons |
| Tampon CS | Validation of Performance User Needs Based on Participant Diary Responses | Tampons that remained white when subject was experiencing flow | 20 Tampons |
| Tampon CS | Validation of Performance User Needs Based on Participant Diary Responses | Tampons participants reported they were able to remove | 2870 Tampons |
Secondary
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
Population: All subjects randomized into the study
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tampon BR | Validation of Performance User Needs Based on Participant Diary Responses. | Participants reporting they were able to open the box and retrieve the wrapped tampons | 322 Participants |
| Tampon BR | Validation of Performance User Needs Based on Participant Diary Responses. | Participants reporting they were able to open each tampon wrapper | 321 Participants |
| Tampon BR | Validation of Performance User Needs Based on Participant Diary Responses. | Participants reporting tampons were clean prior to use | 322 Participants |
| Tampon BR | Validation of Performance User Needs Based on Participant Diary Responses. | Participants reporting they were able to insert the tampons with applicator | 297 Participants |
| Tampon CR | Validation of Performance User Needs Based on Participant Diary Responses. | Participants reporting they were able to open each tampon wrapper | 319 Participants |
| Tampon CR | Validation of Performance User Needs Based on Participant Diary Responses. | Participants reporting tampons were clean prior to use | 320 Participants |
| Tampon CR | Validation of Performance User Needs Based on Participant Diary Responses. | Participants reporting they were able to insert the tampons with applicator | 295 Participants |
| Tampon CR | Validation of Performance User Needs Based on Participant Diary Responses. | Participants reporting they were able to open the box and retrieve the wrapped tampons | 320 Participants |
| Tampon BS | Validation of Performance User Needs Based on Participant Diary Responses. | Participants reporting tampons were clean prior to use | 260 Participants |
| Tampon BS | Validation of Performance User Needs Based on Participant Diary Responses. | Participants reporting they were able to open each tampon wrapper | 260 Participants |
| Tampon BS | Validation of Performance User Needs Based on Participant Diary Responses. | Participants reporting they were able to insert the tampons with applicator | 238 Participants |
| Tampon BS | Validation of Performance User Needs Based on Participant Diary Responses. | Participants reporting they were able to open the box and retrieve the wrapped tampons | 260 Participants |
| Tampon CS | Validation of Performance User Needs Based on Participant Diary Responses. | Participants reporting they were able to insert the tampons with applicator | 249 Participants |
| Tampon CS | Validation of Performance User Needs Based on Participant Diary Responses. | Participants reporting they were able to open each tampon wrapper | 266 Participants |
| Tampon CS | Validation of Performance User Needs Based on Participant Diary Responses. | Participants reporting they were able to open the box and retrieve the wrapped tampons | 266 Participants |
| Tampon CS | Validation of Performance User Needs Based on Participant Diary Responses. | Participants reporting tampons were clean prior to use | 266 Participants |