Trial Outcomes & Findings for Tampon Design Validation Study (NCT NCT05553600)
NCT ID: NCT05553600
Last Updated: 2024-01-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
732 participants
Primary outcome timeframe
At the end of 1 menstrual period (up to 10 days) for each intervention
Results posted on
2024-01-17
Participant Flow
All 732 subjects enrolled were assigned to a study arm.
Participant milestones
| Measure |
Regular Absorbency: BR, Then CR
Participants received tampon code BR (modified regular absorbency tampon) to use during their first menstrual cycle, followed by tampon code CR (regular absorbency reference tampon) to use for their second menstrual cycle.
|
Regular Absorbency: CR, Then BR
Participants received tampon code CR (regular absorbency reference tampon) to use during their first menstrual cycle, followed by tampon code BR (modified regular absorbency tampon) to use for their second menstrual cycle.
|
Super Absorbency: BS, Then CS
Participants received tampon code BS (modified super absorbency tampon) to use during their first menstrual cycle, followed by tampon code CS (super absorbency reference tampon) to use for their second menstrual cycle.
|
Super Absorbency: CS, Then BS
Participants received tampon code CS (super absorbency reference tampon) to use during their first menstrual cycle, followed by tampon code BS (modified super absorbency tampon) to use for their second menstrual cycle.
|
|---|---|---|---|---|
|
Prior to First Menstrual Cycle Starting
STARTED
|
201
|
203
|
166
|
162
|
|
Prior to First Menstrual Cycle Starting
COMPLETED
|
174
|
173
|
145
|
140
|
|
Prior to First Menstrual Cycle Starting
NOT COMPLETED
|
27
|
30
|
21
|
22
|
|
Prior to Second Menstrual Cycle Starting
STARTED
|
174
|
173
|
145
|
140
|
|
Prior to Second Menstrual Cycle Starting
COMPLETED
|
156
|
151
|
132
|
121
|
|
Prior to Second Menstrual Cycle Starting
NOT COMPLETED
|
18
|
22
|
13
|
19
|
|
After Second Menstrual Cycle Began
STARTED
|
156
|
151
|
132
|
121
|
|
After Second Menstrual Cycle Began
COMPLETED
|
155
|
151
|
132
|
121
|
|
After Second Menstrual Cycle Began
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Regular Absorbency: BR, Then CR
Participants received tampon code BR (modified regular absorbency tampon) to use during their first menstrual cycle, followed by tampon code CR (regular absorbency reference tampon) to use for their second menstrual cycle.
|
Regular Absorbency: CR, Then BR
Participants received tampon code CR (regular absorbency reference tampon) to use during their first menstrual cycle, followed by tampon code BR (modified regular absorbency tampon) to use for their second menstrual cycle.
|
Super Absorbency: BS, Then CS
Participants received tampon code BS (modified super absorbency tampon) to use during their first menstrual cycle, followed by tampon code CS (super absorbency reference tampon) to use for their second menstrual cycle.
|
Super Absorbency: CS, Then BS
Participants received tampon code CS (super absorbency reference tampon) to use during their first menstrual cycle, followed by tampon code BS (modified super absorbency tampon) to use for their second menstrual cycle.
|
|---|---|---|---|---|
|
Prior to First Menstrual Cycle Starting
Withdrawal by Subject
|
4
|
8
|
6
|
7
|
|
Prior to First Menstrual Cycle Starting
Protocol Violation
|
0
|
1
|
0
|
2
|
|
Prior to First Menstrual Cycle Starting
Physician Decision
|
0
|
0
|
0
|
1
|
|
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 Second Menstrual Cycle Starting
Adverse Event
|
0
|
0
|
1
|
0
|
|
Prior to Second Menstrual Cycle Starting
Withdrawal by Subject
|
2
|
2
|
4
|
1
|
|
Prior to Second Menstrual Cycle Starting
Protocol Violation
|
1
|
3
|
0
|
1
|
|
Prior to Second Menstrual Cycle Starting
Physician Decision
|
6
|
4
|
1
|
6
|
|
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
|
|
After Second Menstrual Cycle Began
Adverse Event
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Tampon Design Validation Study
Baseline characteristics by cohort
| Measure |
Regular Absorbency
n=404 Participants
Modified regular absorbency tampon versus regular absorbency reference tampon
Tampon BR: Modified Regular Absorbency Tampons
Tampon CR: Reference Regular Absorbency Tampons
|
Super Absorbency
n=328 Participants
Modified super absorbency tampon versus super absorbency reference tampon
Tampon BS: Modified Super Absorbency Tampons
Tampon CS: Reference Super Absorbency Tampons
|
Total
n=732 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.8 years
STANDARD_DEVIATION 8.11 • n=5 Participants
|
34.6 years
STANDARD_DEVIATION 7.62 • n=7 Participants
|
33.6 years
STANDARD_DEVIATION 7.94 • n=5 Participants
|
|
Sex: Female, Male
Female
|
404 Participants
n=5 Participants
|
328 Participants
n=7 Participants
|
732 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
81 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
318 Participants
n=5 Participants
|
264 Participants
n=7 Participants
|
582 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
17 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
115 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
238 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
264 Participants
n=5 Participants
|
185 Participants
n=7 Participants
|
449 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At the end of 1 menstrual period (up to 10 days) for each interventionPopulation: All subjects who have no major protocol deviations and return at least 1 tampon that can be assessed for elongation.
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.
Outcome measures
| Measure |
Tampon BR
n=2635 tampons
Modified regular absorbency tampon
|
Tampon CR
n=2577 tampons
Reference regular absorbency tampon
|
Tampon BS
n=2454 tampons
Modified super absorbency tampon
|
Tampon CS
n=2410 tampons
Reference super absorbency tampon
|
|---|---|---|---|---|
|
The Percentage of Used Tampons That Have Elongated
|
2 tampons
|
75 tampons
|
4 tampons
|
48 tampons
|
SECONDARY outcome
Timeframe: At the end of 1 menstrual period (up to 10 days) for each interventionPopulation: All subjects randomized into the study
Percentage of participants reporting tampons performed as needed through diary responses. The following responses were solicited once at the end of the menstrual period.
Outcome measures
| Measure |
Tampon BR
n=322 Participants
Modified regular absorbency tampon
|
Tampon CR
n=321 Participants
Reference regular absorbency tampon
|
Tampon BS
n=260 Participants
Modified super absorbency tampon
|
Tampon CS
n=266 Participants
Reference super absorbency tampon
|
|---|---|---|---|---|
|
Validation of Performance User Needs Based on Participant Diary Responses.
Participants reporting tampons were clean prior to use
|
322 Participants
|
320 Participants
|
260 Participants
|
266 Participants
|
|
Validation of Performance User Needs Based on Participant Diary Responses.
Participants reporting they were able to insert the tampons with applicator
|
297 Participants
|
295 Participants
|
238 Participants
|
249 Participants
|
|
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
|
320 Participants
|
260 Participants
|
266 Participants
|
|
Validation of Performance User Needs Based on Participant Diary Responses.
Participants reporting they were able to open each tampon wrapper
|
321 Participants
|
319 Participants
|
260 Participants
|
266 Participants
|
SECONDARY outcome
Timeframe: At the end of 1 menstrual period (up to 10 days) for each interventionPopulation: All subjects randomized into the study
Percentage of tampons performing as needed. The following diary responses were solicited after every tampon use.
Outcome measures
| Measure |
Tampon BR
n=3234 Tampons
Modified regular absorbency tampon
|
Tampon CR
n=3141 Tampons
Reference regular absorbency tampon
|
Tampon BS
n=2907 Tampons
Modified super absorbency tampon
|
Tampon CS
n=2877 Tampons
Reference super absorbency tampon
|
|---|---|---|---|---|
|
Validation of Performance User Needs Based on Participant Diary Responses
Tampons that remained white when subject was experiencing flow
|
38 Tampons
|
33 Tampons
|
43 Tampons
|
20 Tampons
|
|
Validation of Performance User Needs Based on Participant Diary Responses
Tampons participants reported they were able to remove
|
3227 Tampons
|
3133 Tampons
|
2904 Tampons
|
2870 Tampons
|
SECONDARY outcome
Timeframe: At baseline, prior to any interventionsPopulation: 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.
Proportion of participants able to locate key packaging/labeling information.
Outcome measures
| Measure |
Tampon BR
n=147 Participants
Modified regular absorbency tampon
|
Tampon CR
Reference regular absorbency tampon
|
Tampon BS
Modified super absorbency tampon
|
Tampon CS
Reference super absorbency tampon
|
|---|---|---|---|---|
|
Validation of Packaging/Labeling User Needs Based on Interview Responses
Able to identify tampon absorbency on regular absorbency box
|
146 Participants
|
—
|
—
|
—
|
|
Validation of Packaging/Labeling User Needs Based on Interview Responses
Able to identify tampon absorbency on super absorbency box
|
146 Participants
|
—
|
—
|
—
|
|
Validation of Packaging/Labeling User Needs Based on Interview Responses
Able to identify tampon absorbency on super plus absorbency box
|
146 Participants
|
—
|
—
|
—
|
|
Validation of Packaging/Labeling User Needs Based on Interview Responses
Able to identify tampon absorbencies on multipack box
|
139 Participants
|
—
|
—
|
—
|
|
Validation of Packaging/Labeling User Needs Based on Interview Responses
Able to identify tampon absorbency ranges for entire line on box
|
147 Participants
|
—
|
—
|
—
|
|
Validation of Packaging/Labeling User Needs Based on Interview Responses
Able to identify toxic shock syndrome warning on box
|
147 Participants
|
—
|
—
|
—
|
|
Validation of Packaging/Labeling User Needs Based on Interview Responses
Able to identify how long a tampon should be used on box
|
132 Participants
|
—
|
—
|
—
|
|
Validation of Packaging/Labeling User Needs Based on Interview Responses
Able to identify regular absorbency wrapped tampon
|
138 Participants
|
—
|
—
|
—
|
|
Validation of Packaging/Labeling User Needs Based on Interview Responses
Able to identify super absorbency wrapped tampon
|
140 Participants
|
—
|
—
|
—
|
|
Validation of Packaging/Labeling User Needs Based on Interview Responses
Able to identify super plus absorbency wrapped tampon
|
139 Participants
|
—
|
—
|
—
|
|
Validation of Packaging/Labeling User Needs Based on Interview Responses
Able to identify instructions for use on insert
|
146 Participants
|
—
|
—
|
—
|
|
Validation of Packaging/Labeling User Needs Based on Interview Responses
Able to identify toxic shock syndrome information on insert
|
144 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each interventionPopulation: All subjects randomized into the study and participating in the gynecological exam subset.
Number of subjects noted during pre- and post-use gynecological exams that had any lesions by anatomical location
Outcome measures
| Measure |
Tampon BR
n=68 Participants
Modified regular absorbency tampon
|
Tampon CR
n=63 Participants
Reference regular absorbency tampon
|
Tampon BS
n=50 Participants
Modified super absorbency tampon
|
Tampon CS
n=54 Participants
Reference super absorbency tampon
|
|---|---|---|---|---|
|
Number of Subjects That Had Any Lesions Noted During Gynecological Exam
Cervix : Post-Use
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects That Had Any Lesions Noted During Gynecological Exam
Perineum : Pre-Use
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects That Had Any Lesions Noted During Gynecological Exam
Perineum : Post-Use
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects That Had Any Lesions Noted During Gynecological Exam
Vulva : Pre-Use
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects That Had Any Lesions Noted During Gynecological Exam
Vulva : Post-Use
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects That Had Any Lesions Noted During Gynecological Exam
Urethra : Pre-Use
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects That Had Any Lesions Noted During Gynecological Exam
Urethra : Post-Use
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects That Had Any Lesions Noted During Gynecological Exam
Vagina : Pre-Use
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects That Had Any Lesions Noted During Gynecological Exam
Vagina : Post-Use
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects That Had Any Lesions Noted During Gynecological Exam
Cervix : Pre-Use
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each interventionPopulation: All subjects randomized into the study and participating in the gynecological exam subset that had pre-use pH readings.
Vaginal pH prior to tampon use.
Outcome measures
| Measure |
Tampon BR
n=62 Participants
Modified regular absorbency tampon
|
Tampon CR
n=62 Participants
Reference regular absorbency tampon
|
Tampon BS
n=48 Participants
Modified super absorbency tampon
|
Tampon CS
n=53 Participants
Reference super absorbency tampon
|
|---|---|---|---|---|
|
Additional Gynecological Exam Results: Pre-use Vaginal pH
|
4.81 pH
Standard Deviation 0.436
|
4.72 pH
Standard Deviation 0.380
|
4.99 pH
Standard Deviation 0.672
|
5.14 pH
Standard Deviation 0.805
|
SECONDARY outcome
Timeframe: Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each interventionPopulation: All subjects randomized into the study and participating in the gynecological exam subset that had post-use pH readings.
Vaginal pH after tampon use.
Outcome measures
| Measure |
Tampon BR
n=65 Participants
Modified regular absorbency tampon
|
Tampon CR
n=57 Participants
Reference regular absorbency tampon
|
Tampon BS
n=48 Participants
Modified super absorbency tampon
|
Tampon CS
n=54 Participants
Reference super absorbency tampon
|
|---|---|---|---|---|
|
Additional Gynecological Exam Results: Post-use Vaginal pH
|
4.85 pH
Standard Deviation 0.499
|
4.76 pH
Standard Deviation 0.412
|
5.19 pH
Standard Deviation 0.848
|
4.86 pH
Standard Deviation 0.518
|
SECONDARY outcome
Timeframe: Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each interventionPopulation: All subjects randomized into the study and participating in the gynecological exam subset.
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.
Outcome measures
| Measure |
Tampon BR
n=68 Participants
Modified regular absorbency tampon
|
Tampon CR
n=63 Participants
Reference regular absorbency tampon
|
Tampon BS
n=50 Participants
Modified super absorbency tampon
|
Tampon CS
n=54 Participants
Reference super absorbency tampon
|
|---|---|---|---|---|
|
Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results
Suspected Infection : Post-Use
|
6 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results
Suspected Infection : Pre-Use
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results
Other abnormal finding : Pre-Use
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results
Other abnormal finding : Post-Use
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Tampon BR
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Tampon CR
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tampon BS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tampon CS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tampon BR
n=323 participants at risk
Modified regular absorbency tampon
|
Tampon CR
n=323 participants at risk
Reference regular absorbency tampon
|
Tampon BS
n=263 participants at risk
Modified super absorbency tampon
|
Tampon CS
n=268 participants at risk
Reference super absorbency tampon
|
|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
0.31%
1/323 • Number of events 1 • Through study completion, an average of 2 months
|
0.00%
0/323 • Through study completion, an average of 2 months
|
0.00%
0/263 • Through study completion, an average of 2 months
|
0.00%
0/268 • Through study completion, an average of 2 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER