Vaginal Microflora
Conditions
Keywords
tampons, Glycerol Monolaurate, vaginal microflora, microbes, Vaginal Tampon
Brief summary
Subjects will be using investigational or control tampons during their menstrual period but these tampons are not intended to prevent, treat or diagnose an infection or other disease condition. A total 450 women will participate in this study at two study sites. Subjects will be randomly assigned to one of three tampon groups. The first group will test an experimental test tampon containing glycerol monolaurate (GML) on the cover. The second group will test an identical tampon, but without GML. The third group will not be issued study tampons but will be instructed to use their normal tampon brand. This study is intended to determine whether the effects of GML observed in the laboratory can be demonstrated in healthy menstruating women.
Detailed description
Subjects will be using investigational or control tampons during their menstrual period but these tampons are not intended to prevent, treat or diagnose an infection or other disease condition. This study will be a randomized, single-blinded, multi-center study of women using Tampons with GML, Tampons without GML or the Tampons Normally Used for one menstrual period. Subjects will undergo Baseline microflora evaluations taken from the vaginal walls 5-10 days following their menstrual period (Baseline evaluation). Subjects will be randomly assigned to use one of the three study products during their next menstrual period. Microflora will be re-evaluated in samples taken from the tampons and from the vaginal walls during use of the study tampons, and from vaginal walls soon after the end of the menstrual period. Evaluations of microflora will be done by quantitative cultures of tampons and vaginal swabs, and also by Nugent scoring of the vaginal swabs. Staphylococcal α-hemolysin and TSST-1 will be analyzed in extracts of the study tampons from subjects found to be colonized with S. aureus. Vaginal pH will be measured, using electronic meters, at each clinic visit. All samples (tampons and vaginal swabs) will be analyzed at a central microbiology laboratory. Extracts of tampons found to contain S. aureus will be forwarded to another central laboratory for the toxin assays. Personnel in the central laboratories will be blinded to the group assignment (study product) for each subject until completion of the study.
Interventions
DEVICEExperimental - Tampon with GML
Regular and Super Tampon with Glycerol Monolaurate (GML) added to the cover
DEVICESham Control - Tampons without GML
There is no intervention associated with these arms - they are sham controls.
Sponsors
Johnson & Johnson Consumer and Personal Products Worldwide
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* normal healthy women * 18-45 years of age * regular 21- to 35-day menstrual cycles with at least 5 days of bleeding, or at least 3 days of bleeding if they are using hormonal contraception * used tampons as their principal mode of menstrual sanitary protection for at least the previous 6 months * willing to not change their feminine care or hygiene practices during their participation in the study (except as directed by the protocol and instructions for participants)
Exclusion criteria
* signs or symptoms of clinically significant vulvovaginal infection or vaginosis * history of recurrent urinary tract or vulvovaginal infection * abnormal vaginal discharge of any etiology * use of a systemic, vaginal, or perineal antibiotic, antifungal, anti-infective, or immunosuppressant medication or any experimental drug or medical device within the 30 days preceding the Screening/Baseline Visit * history of treatment for Toxic Shock Syndrome (TSS) or a suspicion of having had TSS * other clinical issues or history (per protocol) that would make participation in the trial inappropriate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Showing Unfavorable Changes in Primary Microflora | Mid-Cycle Baseline to Mid-Menstrual Samples | Percentage of subjects showing unfavorable changes of at least 1-log in lactobacilli (decrease), C. albicans (increase), or G. vaginalis (increase) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Showing Unfavorable Changes in Primary Microflora | Mid-Cycle Baseline to Post-Menstrual Samples | Percentage of subjects showing unfavorable changes of at least 1-log in lactobacilli (decrease), C. albicans (increase), or G. vaginalis (increase) |
| Percentage of Subjects With Selected Microflora in Tampons | During Menses | Percentage of subjects with selected relevant microorganisms in tampons during menses |
| Abundance of Selected Microflora in Tampons | During Menses | Abundance of selected relevant microorganisms in tampons during menses, in log10 colony forming units (CFU) per gram of menstrual fluid add-on to the tampon, in subjects who had detectable counts of the microorganism. |
| Changes in Nugent Score | Mid-Cycle Baseline to Mid-Menstrual Samples | Percentage of subjects who showed a change in Nugent score from a score of \</= 3 to a score of \>/= 4. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tampon With GML Regular and Super Tampon with GML added to the cover | 162 |
| Tampon Without GML Regular and Super Tampon without GML added to the cover | 159 |
| Tampon Normally Used Type and Size of Tampon Normally Used by Subjects | 161 |
| Total | 482 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 |
| Overall Study | Inadequate Number of Tampons Used | 7 | 2 | 3 |
| Overall Study | Lost to Follow-up | 1 | 1 | 1 |
| Overall Study | Pregnancy | 1 | 3 | 0 |
| Overall Study | Protocol Violation | 5 | 8 | 8 |
| Overall Study | Withdrawal by Subject | 3 | 2 | 2 |
Baseline characteristics
| Characteristic | Tampon With GML | Tampon Without GML | Tampon Normally Used | Total |
|---|---|---|---|---|
| Age, Customized 18 to 64 years, inclusive | 162 Participants | 159 Participants | 161 Participants | 482 Participants |
| Age, Customized <18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Average Cycle 17-35 Days, inclusive | 162 Participants | 159 Participants | 161 Participants | 482 Participants |
| Average Flow 3-10 Days, inclusive 3 to 10 Days, inclusive | 162 Participants | 159 Participants | 161 Participants | 482 Participants |
| Average Flow 3-10 Days, inclusive Less than 3 Days | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Average Flow 3-10 Days, inclusive More than 10 Days | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Body Mass Index 15-54, inclusive | 162 Participants | 159 Participants | 161 Participants | 482 Participants |
| Height 143-148 cm, inclusive | 162 Participants | 159 Participants | 161 Participants | 482 Participants |
| Number of Pregnancies Less than 14 | 162 Participants | 159 Participants | 161 Participants | 482 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 0 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 2 Participants | 3 Participants | 7 Participants |
| Race/Ethnicity, Customized Black or African American | 17 Participants | 12 Participants | 21 Participants | 50 Participants |
| Race/Ethnicity, Customized Hispanic or Latino (H/L) | 18 Participants | 15 Participants | 13 Participants | 46 Participants |
| Race/Ethnicity, Customized H/L & NH/OPI | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian/Other Pacific Islander (NH/OPI) | 4 Participants | 1 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 140 Participants | 142 Participants | 148 Participants | 430 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 1 Participants | 7 Participants | 2 Participants | 10 Participants |
| Race/Ethnicity, Customized White | 141 Participants | 138 Participants | 133 Participants | 412 Participants |
| Region of Enrollment United States | 162 participants | 159 participants | 161 participants | 482 participants |
| Sex/Gender, Customized Female | 162 participants | 159 participants | 161 participants | 482 participants |
| Weight 39-169 kg, inclusive | 162 Participants | 159 Participants | 161 Participants | 482 Participants |
| Years of Tampon Use 1 Year | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Years of Tampon Use 2 to 34 Years, inclusive | 161 Participants | 158 Participants | 160 Participants | 479 Participants |
| Years of Tampon Use Less than 1 Year | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 17 / 162 | 17 / 159 | 12 / 161 |
| serious Total, serious adverse events | 1 / 162 | 3 / 159 | 0 / 161 |
Outcome results
Primary
Percentage of Subjects Showing Unfavorable Changes in Primary Microflora
Percentage of subjects showing unfavorable changes of at least 1-log in lactobacilli (decrease), C. albicans (increase), or G. vaginalis (increase)
Time frame: Mid-Cycle Baseline to Mid-Menstrual Samples
Population: Microbiological analyses are for the per protocol population, and no data imputation was performed. Analysis was limited to those subjects whose samples were viable for culture upon receipt at the laboratory.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tampon With GML | Percentage of Subjects Showing Unfavorable Changes in Primary Microflora | 52.7 Percentage of Participants |
| Tampon Without GML | Percentage of Subjects Showing Unfavorable Changes in Primary Microflora | 52.9 Percentage of Participants |
| Tampon Normally Used | Percentage of Subjects Showing Unfavorable Changes in Primary Microflora | 60.0 Percentage of Participants |
Secondary
Abundance of Selected Microflora in Tampons
Abundance of selected relevant microorganisms in tampons during menses, in log10 colony forming units (CFU) per gram of menstrual fluid add-on to the tampon, in subjects who had detectable counts of the microorganism.
Time frame: During Menses
Population: Microbiological analyses are for the per protocol population, and no data imputation was performed. Analysis was limited to those subjects whose samples were viable for culture upon receipt at the laboratory.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tampon With GML | Abundance of Selected Microflora in Tampons | C. albicans | 3.3 CFU/gm | Standard Deviation 1.3 |
| Tampon With GML | Abundance of Selected Microflora in Tampons | Staphylococcus aureus | 5.6 CFU/gm | Standard Deviation 1.9 |
| Tampon With GML | Abundance of Selected Microflora in Tampons | E. coli | 4.8 CFU/gm | Standard Deviation 1.9 |
| Tampon With GML | Abundance of Selected Microflora in Tampons | Lactobacilli | 5.5 CFU/gm | Standard Deviation 1.4 |
| Tampon With GML | Abundance of Selected Microflora in Tampons | Enterococcus sp. | 5.1 CFU/gm | Standard Deviation 1.5 |
| Tampon With GML | Abundance of Selected Microflora in Tampons | Group B Streptococcus | 6.6 CFU/gm | Standard Deviation 1.7 |
| Tampon With GML | Abundance of Selected Microflora in Tampons | G. vaginalis | 6.2 CFU/gm | Standard Deviation 1.5 |
| Tampon Without GML | Abundance of Selected Microflora in Tampons | E. coli | 4.7 CFU/gm | Standard Deviation 2 |
| Tampon Without GML | Abundance of Selected Microflora in Tampons | Lactobacilli | 6.0 CFU/gm | Standard Deviation 1.2 |
| Tampon Without GML | Abundance of Selected Microflora in Tampons | C. albicans | 3.7 CFU/gm | Standard Deviation 1.9 |
| Tampon Without GML | Abundance of Selected Microflora in Tampons | G. vaginalis | 6.6 CFU/gm | Standard Deviation 1.2 |
| Tampon Without GML | Abundance of Selected Microflora in Tampons | Staphylococcus aureus | 4.8 CFU/gm | Standard Deviation 1.7 |
| Tampon Without GML | Abundance of Selected Microflora in Tampons | Group B Streptococcus | 6.9 CFU/gm | Standard Deviation 1.2 |
| Tampon Without GML | Abundance of Selected Microflora in Tampons | Enterococcus sp. | 5.0 CFU/gm | Standard Deviation 1.4 |
| Tampon Normally Used | Abundance of Selected Microflora in Tampons | Staphylococcus aureus | 4.7 CFU/gm | Standard Deviation 1.2 |
| Tampon Normally Used | Abundance of Selected Microflora in Tampons | C. albicans | 3.9 CFU/gm | Standard Deviation 1.5 |
| Tampon Normally Used | Abundance of Selected Microflora in Tampons | Enterococcus sp. | 5.3 CFU/gm | Standard Deviation 1.5 |
| Tampon Normally Used | Abundance of Selected Microflora in Tampons | Group B Streptococcus | 6.7 CFU/gm | Standard Deviation 1.6 |
| Tampon Normally Used | Abundance of Selected Microflora in Tampons | E. coli | 5.1 CFU/gm | Standard Deviation 2.2 |
| Tampon Normally Used | Abundance of Selected Microflora in Tampons | G. vaginalis | 6.3 CFU/gm | Standard Deviation 1.3 |
| Tampon Normally Used | Abundance of Selected Microflora in Tampons | Lactobacilli | 6.0 CFU/gm | Standard Deviation 1.2 |
Secondary
Changes in Nugent Score
Percentage of subjects who showed a change in Nugent score from a score of \</= 3 to a score of \>/= 4.
Time frame: Mid-Cycle Baseline to Mid-Menstrual Samples
Population: Microbiological analyses are for the per protocol population, and no data imputation was performed. Analysis was limited to those subjects whose samples were viable for culture upon receipt at the laboratory.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tampon With GML | Changes in Nugent Score | 17.7 Percentage of Participants |
| Tampon Without GML | Changes in Nugent Score | 19.3 Percentage of Participants |
| Tampon Normally Used | Changes in Nugent Score | 24.8 Percentage of Participants |
Secondary
Changes in Nugent Score
Percentage of subjects who showed a change in Nugent score from a score of \</= 3 to a score of \>/= 4.
Time frame: Mid-Cycle Baseline to Post-Menstrual Samples
Population: Microbiological analyses are for the per protocol population, and no data imputation was performed. Analysis was limited to those subjects whose samples were viable for culture upon receipt at the laboratory.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tampon With GML | Changes in Nugent Score | 5.9 Percentage of Participants |
| Tampon Without GML | Changes in Nugent Score | 12.9 Percentage of Participants |
| Tampon Normally Used | Changes in Nugent Score | 10.6 Percentage of Participants |
Secondary
Percentage of Subjects Showing Unfavorable Changes in Primary Microflora
Percentage of subjects showing unfavorable changes of at least 1-log in lactobacilli (decrease), C. albicans (increase), or G. vaginalis (increase)
Time frame: Mid-Cycle Baseline to Post-Menstrual Samples
Population: Microbiological analyses are for the per protocol population, and no data imputation was performed. Analysis was limited to those subjects whose samples were viable for culture upon receipt at the laboratory.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tampon With GML | Percentage of Subjects Showing Unfavorable Changes in Primary Microflora | 31.6 Percentage of Participants |
| Tampon Without GML | Percentage of Subjects Showing Unfavorable Changes in Primary Microflora | 34.3 Percentage of Participants |
| Tampon Normally Used | Percentage of Subjects Showing Unfavorable Changes in Primary Microflora | 36.4 Percentage of Participants |
Secondary
Percentage of Subjects With Selected Microflora in Tampons
Percentage of subjects with selected relevant microorganisms in tampons during menses
Time frame: During Menses
Population: Microbiological analyses are for the per protocol population, and no data imputation was performed. Analysis was limited to those subjects whose samples were viable for culture upon receipt at the laboratory.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tampon With GML | Percentage of Subjects With Selected Microflora in Tampons | C. albicans | 16.2 Percentage of Participants |
| Tampon With GML | Percentage of Subjects With Selected Microflora in Tampons | Staphylococcus aureus | 12.3 Percentage of Participants |
| Tampon With GML | Percentage of Subjects With Selected Microflora in Tampons | E. coli | 28.5 Percentage of Participants |
| Tampon With GML | Percentage of Subjects With Selected Microflora in Tampons | Lactobacilli | 89.2 Percentage of Participants |
| Tampon With GML | Percentage of Subjects With Selected Microflora in Tampons | Enterococcus sp. | 46.2 Percentage of Participants |
| Tampon With GML | Percentage of Subjects With Selected Microflora in Tampons | Group B Streptococcus | 26.9 Percentage of Participants |
| Tampon With GML | Percentage of Subjects With Selected Microflora in Tampons | G. vaginalis | 27.7 Percentage of Participants |
| Tampon Without GML | Percentage of Subjects With Selected Microflora in Tampons | E. coli | 41.4 Percentage of Participants |
| Tampon Without GML | Percentage of Subjects With Selected Microflora in Tampons | Lactobacilli | 85.0 Percentage of Participants |
| Tampon Without GML | Percentage of Subjects With Selected Microflora in Tampons | C. albicans | 12.1 Percentage of Participants |
| Tampon Without GML | Percentage of Subjects With Selected Microflora in Tampons | G. vaginalis | 43.6 Percentage of Participants |
| Tampon Without GML | Percentage of Subjects With Selected Microflora in Tampons | Staphylococcus aureus | 17.9 Percentage of Participants |
| Tampon Without GML | Percentage of Subjects With Selected Microflora in Tampons | Group B Streptococcus | 22.1 Percentage of Participants |
| Tampon Without GML | Percentage of Subjects With Selected Microflora in Tampons | Enterococcus sp. | 37.9 Percentage of Participants |
| Tampon Normally Used | Percentage of Subjects With Selected Microflora in Tampons | Staphylococcus aureus | 13.5 Percentage of Participants |
| Tampon Normally Used | Percentage of Subjects With Selected Microflora in Tampons | C. albicans | 19.1 Percentage of Participants |
| Tampon Normally Used | Percentage of Subjects With Selected Microflora in Tampons | Enterococcus sp. | 40.4 Percentage of Participants |
| Tampon Normally Used | Percentage of Subjects With Selected Microflora in Tampons | Group B Streptococcus | 25.5 Percentage of Participants |
| Tampon Normally Used | Percentage of Subjects With Selected Microflora in Tampons | E. coli | 34.8 Percentage of Participants |
| Tampon Normally Used | Percentage of Subjects With Selected Microflora in Tampons | G. vaginalis | 46.1 Percentage of Participants |
| Tampon Normally Used | Percentage of Subjects With Selected Microflora in Tampons | Lactobacilli | 85.1 Percentage of Participants |