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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regular Absorbency | Other | Modified regular absorbency tampon versus regular absorbency reference tampon |
|
| Super Absorbency | Other | Modified super absorbency tampon versus super absorbency reference tampon |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tampon BR | Device | Modified Regular Absorbency Tampons |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the end of 1 menstrual period (up to 10 days) for each intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the end of 1 menstrual period (up to 10 days) for each intervention |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Del Sol Research Management, LLC | Tucson | Arizona | 85715 | United States | ||
| Agile Clinical Research Trials, LLC |
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All 732 subjects enrolled were assigned to a study arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Prior to First Menstrual Cycle Starting |
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| Prior to Second Menstrual Cycle Starting |
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| After Second Menstrual Cycle Began |
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| ID | Title | Description |
|---|---|---|
| BG000 | Regular Absorbency | Modified regular absorbency tampon versus regular absorbency reference tampon Tampon BR: Modified Regular Absorbency Tampons Tampon CR: Reference Regular Absorbency Tampons |
| BG001 | Super Absorbency |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All subjects who have no major protocol deviations and return at least 1 tampon that can be assessed for elongation. | Posted | Count of Units | tampons | At the end of 1 menstrual period (up to 10 days) for each intervention | tampons | tampons |
|
Through study completion, an average of 2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tampon BR | Modified regular absorbency tampon | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA (v.25.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jin Zhang | Kimberly-Clark Corporation | 770-587-8000 | jin.zhang@kcc.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 24, 2022 | Nov 14, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 5, 2023 | Nov 14, 2023 | SAP_001.pdf |
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| Tampon CR |
| Device |
Reference Regular Absorbency Tampons |
|
| Tampon BS | Device | Modified Super Absorbency Tampons |
|
| Tampon CS | Device | Reference Super Absorbency Tampons |
|
| 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. |
| 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. | 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 | 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. | 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. | 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. | Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention |
| 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 |
| Protocol Violation |
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| Physician Decision |
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| Lost to Follow-up |
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| Other various reasons |
|
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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|
Modified super absorbency tampon versus super absorbency reference tampon
Tampon BS: Modified Super Absorbency Tampons
Tampon CS: Reference Super Absorbency Tampons
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | Tampon BS | Modified super absorbency tampon |
| OG003 | Tampon CS | Reference super absorbency tampon |
|
|
| 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. | All subjects randomized into the study | Posted | Count of Participants | Participants | At the end of 1 menstrual period (up to 10 days) for each intervention |
|
|
|
| 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. | All subjects randomized into the study | Posted | Count of Units | Tampons | At the end of 1 menstrual period (up to 10 days) for each intervention | Tampons | Tampons |
|
|
|
| Secondary | Validation of Packaging/Labeling User Needs Based on Interview Responses | Proportion of participants able to locate key packaging/labeling information. | 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. | Posted | Count of Participants | Participants | At baseline, prior to any interventions |
|
|
|
| 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 | All subjects randomized into the study and participating in the gynecological exam subset. | Posted | Count of Participants | Participants | Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention |
|
|
|
| Secondary | Additional Gynecological Exam Results: Pre-use Vaginal pH | Vaginal pH prior to tampon use. | All subjects randomized into the study and participating in the gynecological exam subset that had pre-use pH readings. | Posted | Mean | Standard Deviation | pH | Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention |
|
|
|
| Secondary | Additional Gynecological Exam Results: Post-use Vaginal pH | Vaginal pH after tampon use. | All subjects randomized into the study and participating in the gynecological exam subset that had post-use pH readings. | Posted | Mean | Standard Deviation | pH | Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention |
|
|
|
| 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. | All subjects randomized into the study and participating in the gynecological exam subset. | Posted | Count of Participants | Participants | Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention |
|
|
|
| 323 |
| 1 |
| 323 |
| 0 |
| 323 |
| EG001 | Tampon CR | Reference regular absorbency tampon | 0 | 323 | 0 | 323 | 0 | 323 |
| EG002 | Tampon BS | Modified super absorbency tampon | 0 | 263 | 0 | 263 | 0 | 263 |
| EG003 | Tampon CS | Reference super absorbency tampon | 0 | 268 | 0 | 268 | 0 | 268 |
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| Participants reporting they were able to open each tampon wrapper |
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| Participants reporting tampons were clean prior to use |
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| Participants reporting they were able to insert the tampons with applicator |
|
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| Tampons participants reported they were able to remove |
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| Able to identify tampon absorbency on super plus absorbency box |
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| Able to identify tampon absorbencies on multipack box |
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| Able to identify tampon absorbency ranges for entire line on box |
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| Able to identify toxic shock syndrome warning on box |
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| Able to identify how long a tampon should be used on box |
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| Able to identify regular absorbency wrapped tampon |
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| Able to identify super absorbency wrapped tampon |
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| Able to identify super plus absorbency wrapped tampon |
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| Able to identify instructions for use on insert |
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| Able to identify toxic shock syndrome information on insert |
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| Perineum : Post-Use |
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| Vulva : Pre-Use |
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| Vulva : Post-Use |
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| Urethra : Pre-Use |
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| Urethra : Post-Use |
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| Vagina : Pre-Use |
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| Vagina : Post-Use |
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| Cervix : Pre-Use |
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| Cervix : Post-Use |
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| Suspected Infection : Post-Use |
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| Other abnormal finding : Pre-Use |
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| Other abnormal finding : Post-Use |
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| Clinically significant exam results : Pre-Use |
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| Clinically significant exam results : Post-Use |
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