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Examining the Impact of Tampon Use on the Vaginal Microbiota

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ClinicalTrials.gov Identifier: NCT03346759
Recruitment Status : Completed
First Posted : November 17, 2017
Results First Posted : July 20, 2018
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Jason Bell, MD, MPH, MS, University of Michigan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Vaginal Microbiota
Interventions Device: Tampon A
Device: Tampon B
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tampon A First Tampon B First
Hide Arm/Group Description 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. 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.
Period Title: Enrollment to Baseline Data Collected
Started 15 13
Completed 13 [1] 10 [2]
Not Completed 2 3
Reason Not Completed
Lost to Follow-up             2             3
[1]
Participants assigned to the Tampon A First arm who provided at least one vaginal microbiota sample.
[2]
Participants assigned to the Tampon B First arm who provided at least one vaginal microbiota sample.
Period Title: First Menstrual Cycle
Started 13 10
Completed 12 10
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Period Title: Second Menstrual Cycle
Started 12 10
Completed 11 10
Not Completed 1 0
Reason Not Completed
Lost to Follow-up             1             0
Period Title: Third Menstrual Cycle
Started 11 10
Completed 11 10
Not Completed 0 0
Arm/Group Title Tampon A First Tampon B First Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 13 10 23
Hide Baseline Analysis Population Description
Participants who provided at least one vaginal microbiota sample.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 10 participants 23 participants
27.6  (5.0) 24.3  (4.0) 26.1  (4.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 10 participants 23 participants
Female
13
 100.0%
10
 100.0%
23
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 10 participants 23 participants
Non-Hispanic white
10
  76.9%
8
  80.0%
18
  78.3%
Asian
1
   7.7%
0
   0.0%
1
   4.3%
Hispanic
0
   0.0%
2
  20.0%
2
   8.7%
Black
0
   0.0%
0
   0.0%
0
   0.0%
Other
2
  15.4%
0
   0.0%
2
   8.7%
Relative abundance of Lactobacillus species   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Relative abundance
Number Analyzed 13 participants 10 participants 23 participants
.9667
(.9192 to .9898)
.9727
(.9521 to .9877)
.9705
(.9301 to .9894)
[1]
Measure Description: 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.
Relative abundance of Gardnerella vaginalis   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Relative abundance
Number Analyzed 13 participants 10 participants 23 participants
.000091
(0 to .000094)
.000019
(0 to .000136)
.000045
(0 to .000499)
[1]
Measure Description: 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.
1.Primary Outcome
Title Change in Relative Abundance of Lactobacillus Species
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed are those that provided samples through the end of the given menstrual cycle.
Arm/Group Title Tampon A First Tampon B First
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 12 10
Median (Inter-Quartile Range)
Unit of Measure: relative abundance
Baseline to end of first cycle Number Analyzed 12 participants 10 participants
.0084
(-.0017 to .0274)
-.0014
(-.0148 to .0242)
Baseline to end of second cycle Number Analyzed 11 participants 10 participants
-.00004
(-.0121 to .0368)
.0104
(-.0346 to .0354)
Baseline to end of third menstrual cycle Number Analyzed 11 participants 10 participants
-.0350
(-.1723 to .0304)
.0238
(.0107 to .0349)
2.Secondary Outcome
Title Change in Relative Abundance of Gardnerella Vaginalis
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed are those that provided samples through the end of the given menstrual cycle.
Arm/Group Title Tampon A First Tampon B First
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 12 10
Median (Inter-Quartile Range)
Unit of Measure: relative abundance
Baseline to end of first cycle Number Analyzed 12 participants 10 participants
.000046
(-.000303 to .004230)
0
(-.000124 to 0)
Baseline to end of second cycle Number Analyzed 11 participants 10 participants
-.000045
(-.000788 to .001620)
0
(-.000115 to 0)
Baseline to 14 weeks Number Analyzed 11 participants 10 participants
-.000045
(-.004297 to .000030)
0
(-.000124 to .000075)
Time Frame Adverse event data were collected for the duration of study participation for each subject (baseline window and menstrual cycles 1, 2, and 3; approximately 14 weeks per subject).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tampon A Tampon B Tampon of Choice (Third Period)
Hide Arm/Group Description All participants while using Tampax Pearl Regular Tampons regardless of tampon sequence. All participants while using Playtex Gentle Glide 360 Regular Tampons regardless of tampon sequence. All participants during the third menstrual cycle.
All-Cause Mortality
Tampon A Tampon B Tampon of Choice (Third Period)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/21 (0.00%)   0/21 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Tampon A Tampon B Tampon of Choice (Third Period)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/21 (0.00%)   0/21 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tampon A Tampon B Tampon of Choice (Third Period)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/21 (0.00%)   0/21 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Jason Bell, MD
Organization: University of Michigan
Phone: 7342323897
Responsible Party: Jason Bell, MD, MPH, MS, University of Michigan
ClinicalTrials.gov Identifier: NCT03346759     History of Changes
Other Study ID Numbers: HUM00122922
First Submitted: November 15, 2017
First Posted: November 17, 2017
Results First Submitted: May 1, 2018
Results First Posted: July 20, 2018
Last Update Posted: August 23, 2018