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This study will evaluate the impact on vaginal health of four different tampons using gynecologic assessment and subjective assessment of comfort during in-use conditions
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Marketed Tampon D | Sham Comparator | Regular absorbency tampon |
|
| Marketed Tampon M | Sham Comparator | Regular absorbency tampon |
|
| Marketed Tampon T | Sham Comparator | Regular absorbency tampon |
|
| Marketed Tampon V | Sham Comparator | Regular absorbency tampon |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tampon D | Device | regular absorbency tampon |
| |
| tampon M |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance of Tampon Wear Via Physician Assessment of Vaginal Health | The physician examiner determined tampon tolerance based on the following: 1) Vaginal erythema (0-4 scale), 2) vaginal lacerations (presence or absence), 3) vaginal abrasions (presence or absence), 4) vaginal pH, 5) vaginal discharge | within 72 hours last tampon use |
| Vaginal pH | Vaginal pH | within 72 hours last tampon use |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Comfort Diary | Diary assessment of tampon wear comfort. This assessment uses a 5-point scale which was summarized using the mean as the summary statistic. This questionnaire measured overall comfort using a +2 to -2 scale that was converted to a 0 to 100 scale: 100 = excellent rating and 0 =poor rating | 4 months |
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Inclusion Criteria: To be considered eligible for enrollment into this study subjects must meet the following criteria:
Exclusion Criteria: Subjects will be excluded from the study if they meet any of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Noss, MD | Site Medical Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Synexus-US | Cincinnati | Ohio | 45236 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37408999 | Derived | Hochwalt AE, Abbinante-Nissen JM, Bohman LC, Hattersley AM, Hu P, Streicher-Scott JL, Teufel AG, Woeller KE. The safety assessment of tampons: illustration of a comprehensive approach for four different products. Front Reprod Health. 2023 Jun 20;5:1167868. doi: 10.3389/frph.2023.1167868. eCollection 2023. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study | This was a single center, double-blind 4 treatment, 4 period cross-over design. Each participant received each test product for one menstrual cycle. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | This was a single center, double-blind 4 treatment, 4 period cross-over design. Each participant received each test product for one menstrual cycle. |
| 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 | Tolerance of Tampon Wear Via Physician Assessment of Vaginal Health | The physician examiner determined tampon tolerance based on the following: 1) Vaginal erythema (0-4 scale), 2) vaginal lacerations (presence or absence), 3) vaginal abrasions (presence or absence), 4) vaginal pH, 5) vaginal discharge | ITT population was the primary population of analysis. The ITT population was defined as those participants who were randomized, received at least one test product and had at least one post-product use measurement. | Posted | Count of Participants | Participants | within 72 hours last tampon use |
|
six 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 | Marketed Tampon D | Regular absorbency tampon tampon D: regular absorbency tampon |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post-traumatic stress disorder | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jan Streicher-Scott, PhD, RPh | Procter & Gamble Co | 513-634-5584 | streicherscott.jl@pg.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 11, 2018 | Aug 8, 2019 | Prot_SAP_000.pdf |
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| Device |
regular absorbency tampon |
|
| tampon T | Device | regular absorbency tampon |
|
| tampon V | Device | regular absorbency tampon |
|
| Subject Comfort Questionnaire |
Post-menstruation assessment of tampon wear comfort. This assessment uses a 5-point scale which was summarized using the mean as the summary statistic. This questionnaire measured overall satisfaction using a +2 to -2 scale that was converted to a 0 to 100 scale: 100 = excellent rating and 0 = poor rating |
| 4 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Regular absorbency tampon tampon M: regular absorbency tampon |
| OG002 | Marketed Tampon T | Regular absorbency tampon tampon T: regular absorbency tampon |
| OG003 | Marketed Tampon V | Regular absorbency tampon tampon V: regular absorbency tampon |
|
|
| Primary | Vaginal pH | Vaginal pH | ITT population was the primary population of analysis. The ITT population was defined as those participants who were randomized, received at least one test product and had at least one post-product use measurement. | Posted | Mean | Standard Error | pH | within 72 hours last tampon use |
|
|
|
| Secondary | Subject Comfort Diary | Diary assessment of tampon wear comfort. This assessment uses a 5-point scale which was summarized using the mean as the summary statistic. This questionnaire measured overall comfort using a +2 to -2 scale that was converted to a 0 to 100 scale: 100 = excellent rating and 0 =poor rating | ITT population was the primary population of analysis. The ITT population was defined as those participants who were randomized, received at least one test product and had at least one post-product use measurement. | Posted | Mean | Standard Error | units on a scale | 4 months |
|
|
|
| Secondary | Subject Comfort Questionnaire | Post-menstruation assessment of tampon wear comfort. This assessment uses a 5-point scale which was summarized using the mean as the summary statistic. This questionnaire measured overall satisfaction using a +2 to -2 scale that was converted to a 0 to 100 scale: 100 = excellent rating and 0 = poor rating | ITT population was the primary population of analysis. The ITT population was defined as those participants who were randomized, received at least one test product and had at least one post-product use measurement. | Posted | Mean | Standard Error | units on a scale | 4 months |
|
|
|
| 0 |
| 91 |
| 1 |
| 91 |
| 0 |
| 91 |
| EG001 | Marketed Tampon M | Regular absorbency tampon tampon M: regular absorbency tampon | 0 | 92 | 0 | 92 | 0 | 92 |
| EG002 | Marketed Tampon T | Regular absorbency tampon tampon T: regular absorbency tampon | 0 | 90 | 0 | 90 | 0 | 90 |
| EG003 | Marketed Tampon V | Regular absorbency tampon tampon V: regular absorbency tampon | 0 | 91 | 0 | 91 | 0 | 91 |
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