Trial Outcomes & Findings for Examining the Impact of Tampon Use on the Vaginal Microbiota (NCT NCT03346759)
NCT ID: NCT03346759
Last Updated: 2018-08-23
Results Overview
The differences in relative abundance of Lactobacillus species between: the last swab collected during menstrual cycle 1 and the first swab collected, the last swab collected during menstrual cycle 2 and the first swab collected, and the last swab collected during menstrual cycle 3 and the first swab collected. Relative abundance is defined as the proportion of total identified bacteria in a sample that are a given type of bacteria. The Lactobacillus species included here are L. crispatus, L. iners, L. gasseri, and L. jensenii. Thus, a relative abundance of Lactobacillus species equal to 0.9 would mean that 90% of the bacteria identified in a sample are Lactobacillus species.
COMPLETED
PHASE4
28 participants
Baseline, end of first menstrual cycle (approximately 6 weeks), end of second menstrual cycle (approximately 10 weeks), and end of third menstrual cycle (approximately 14 weeks)
2018-08-23
Participant Flow
Participant milestones
| Measure |
Tampon A First
Subjects were provided with 24 Tampax Pearl Regular Tampons (tampon A) to use exclusively for the first of two consecutive menstrual cycles. Subjects were then provided with 24 Playtex Gentle Glide 360 Regular Tampons (tampon B) to use exclusively for the second of two consecutive menstrual cycles. For the third menstrual cycle, subject used tampons of their choosing.
|
Tampon B First
Subjects were provided with 24 Playtex Gentle Glide 360 Regular Tampons (tampon B) to use exclusively for the first of two consecutive menstrual cycles. Subjects were then provided with 24 Tampax Pearl Regular Tampons (tampon A) to use exclusively for the second of two consecutive menstrual cycles. For the third menstrual cycle, subject used tampons of their choosing.
|
|---|---|---|
|
Enrollment to Baseline Data Collected
STARTED
|
15
|
13
|
|
Enrollment to Baseline Data Collected
COMPLETED
|
13
|
10
|
|
Enrollment to Baseline Data Collected
NOT COMPLETED
|
2
|
3
|
|
First Menstrual Cycle
STARTED
|
13
|
10
|
|
First Menstrual Cycle
COMPLETED
|
12
|
10
|
|
First Menstrual Cycle
NOT COMPLETED
|
1
|
0
|
|
Second Menstrual Cycle
STARTED
|
12
|
10
|
|
Second Menstrual Cycle
COMPLETED
|
11
|
10
|
|
Second Menstrual Cycle
NOT COMPLETED
|
1
|
0
|
|
Third Menstrual Cycle
STARTED
|
11
|
10
|
|
Third Menstrual Cycle
COMPLETED
|
11
|
10
|
|
Third Menstrual Cycle
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Tampon A First
Subjects were provided with 24 Tampax Pearl Regular Tampons (tampon A) to use exclusively for the first of two consecutive menstrual cycles. Subjects were then provided with 24 Playtex Gentle Glide 360 Regular Tampons (tampon B) to use exclusively for the second of two consecutive menstrual cycles. For the third menstrual cycle, subject used tampons of their choosing.
|
Tampon B First
Subjects were provided with 24 Playtex Gentle Glide 360 Regular Tampons (tampon B) to use exclusively for the first of two consecutive menstrual cycles. Subjects were then provided with 24 Tampax Pearl Regular Tampons (tampon A) to use exclusively for the second of two consecutive menstrual cycles. For the third menstrual cycle, subject used tampons of their choosing.
|
|---|---|---|
|
Enrollment to Baseline Data Collected
Lost to Follow-up
|
2
|
3
|
|
First Menstrual Cycle
Withdrawal by Subject
|
1
|
0
|
|
Second Menstrual Cycle
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Examining the Impact of Tampon Use on the Vaginal Microbiota
Baseline characteristics by cohort
| Measure |
Tampon A First
n=13 Participants
Subjects were provided with 24 Tampax Pearl Regular Tampons (tampon A) to use exclusively for the first of two consecutive menstrual cycles. Subjects were then provided with 24 Playtex Gentle Glide 360 Regular Tampons (tampon B) to use exclusively for the second of two consecutive menstrual cycles. For the third menstrual cycle, subject used tampons of their choosing.
|
Tampon B First
n=10 Participants
Subjects were provided with 24 Playtex Gentle Glide 360 Regular Tampons (tampon B) to use exclusively for the first of two consecutive menstrual cycles. Subjects were then provided with 24 Tampax Pearl Regular Tampons (tampon A) to use exclusively for the second of two consecutive menstrual cycles. For the third menstrual cycle, subject used tampons of their choosing.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.6 years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
24.3 years
STANDARD_DEVIATION 4.0 • n=7 Participants
|
26.1 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic white
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Relative abundance of Lactobacillus species
|
.9667 relative abundance
n=5 Participants
|
.9727 relative abundance
n=7 Participants
|
.9705 relative abundance
n=5 Participants
|
|
Relative abundance of Gardnerella vaginalis
|
.000091 relative abundance
n=5 Participants
|
.000019 relative abundance
n=7 Participants
|
.000045 relative abundance
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, end of first menstrual cycle (approximately 6 weeks), end of second menstrual cycle (approximately 10 weeks), and end of third menstrual cycle (approximately 14 weeks)Population: Participants analyzed are those that provided samples through the end of the given menstrual cycle.
The differences in relative abundance of Lactobacillus species between: the last swab collected during menstrual cycle 1 and the first swab collected, the last swab collected during menstrual cycle 2 and the first swab collected, and the last swab collected during menstrual cycle 3 and the first swab collected. Relative abundance is defined as the proportion of total identified bacteria in a sample that are a given type of bacteria. The Lactobacillus species included here are L. crispatus, L. iners, L. gasseri, and L. jensenii. Thus, a relative abundance of Lactobacillus species equal to 0.9 would mean that 90% of the bacteria identified in a sample are Lactobacillus species.
Outcome measures
| Measure |
Tampon A First
n=12 Participants
Subjects were provided with 24 Tampax Pearl Regular Tampons (tampon A) to use exclusively for the first of two consecutive menstrual cycles. Subjects were then provided with 24 Playtex Gentle Glide 360 Regular Tampons (tampon B) to use exclusively for the second of two consecutive menstrual cycles. For the third menstrual cycle, subject used tampons of their choosing.
|
Tampon B First
n=10 Participants
Subjects were provided with 24 Playtex Gentle Glide 360 Regular Tampons (tampon B) to use exclusively for the first of two consecutive menstrual cycles. Subjects were then provided with 24 Tampax Pearl Regular Tampons (tampon A) to use exclusively for the second of two consecutive menstrual cycles. For the third menstrual cycle, subject used tampons of their choosing.
|
|---|---|---|
|
Change in Relative Abundance of Lactobacillus Species
Baseline to end of first cycle
|
.0084 relative abundance
Interval -0.0017 to 0.0274
|
-.0014 relative abundance
Interval -0.0148 to 0.0242
|
|
Change in Relative Abundance of Lactobacillus Species
Baseline to end of second cycle
|
-.00004 relative abundance
Interval -0.0121 to 0.0368
|
.0104 relative abundance
Interval -0.0346 to 0.0354
|
|
Change in Relative Abundance of Lactobacillus Species
Baseline to end of third menstrual cycle
|
-.0350 relative abundance
Interval -0.1723 to 0.0304
|
.0238 relative abundance
Interval 0.0107 to 0.0349
|
SECONDARY outcome
Timeframe: Baseline, end of first menstrual cycle (approximately 6 weeks), end of second menstrual cycle (approximately 10 weeks), and end of third menstrual cycle (approximately 14 weeks)Population: Participants analyzed are those that provided samples through the end of the given menstrual cycle.
The differences in relative abundance of Gardnerella vaginalis between: the last swab collected during menstrual cycle 1 and the first swab collected, the last swab collected during menstrual cycle 2 and the first swab collected, and the last swab collected during menstrual cycle 3 and the first swab collected. Relative abundance is defined as the proportion of total identified bacteria in a sample that are a given type of bacteria. Thus, a relative abundance of Gardnerella vaginalis equal to 0.9 would mean that 90% of the bacteria identified in a sample are Gardnerella vaginalis.
Outcome measures
| Measure |
Tampon A First
n=12 Participants
Subjects were provided with 24 Tampax Pearl Regular Tampons (tampon A) to use exclusively for the first of two consecutive menstrual cycles. Subjects were then provided with 24 Playtex Gentle Glide 360 Regular Tampons (tampon B) to use exclusively for the second of two consecutive menstrual cycles. For the third menstrual cycle, subject used tampons of their choosing.
|
Tampon B First
n=10 Participants
Subjects were provided with 24 Playtex Gentle Glide 360 Regular Tampons (tampon B) to use exclusively for the first of two consecutive menstrual cycles. Subjects were then provided with 24 Tampax Pearl Regular Tampons (tampon A) to use exclusively for the second of two consecutive menstrual cycles. For the third menstrual cycle, subject used tampons of their choosing.
|
|---|---|---|
|
Change in Relative Abundance of Gardnerella Vaginalis
Baseline to 14 weeks
|
-.000045 relative abundance
Interval -0.004297 to 0.00003
|
0 relative abundance
Interval -0.000124 to 0.000075
|
|
Change in Relative Abundance of Gardnerella Vaginalis
Baseline to end of first cycle
|
.000046 relative abundance
Interval -0.000303 to 0.00423
|
0 relative abundance
Interval -0.000124 to 0.0
|
|
Change in Relative Abundance of Gardnerella Vaginalis
Baseline to end of second cycle
|
-.000045 relative abundance
Interval -0.000788 to 0.00162
|
0 relative abundance
Interval -0.000115 to 0.0
|
Adverse Events
Tampon A
Tampon B
Tampon of Choice (Third Period)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place