Trial Outcomes & Findings for Clinical Evaluation of Effects of an Investigational Tampon on Vaginal Microflora (NCT NCT00913523)
NCT ID: NCT00913523
Last Updated: 2011-08-23
Results Overview
Percentage of subjects showing unfavorable changes of at least 1-log in lactobacilli (decrease), C. albicans (increase), or G. vaginalis (increase)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
482 participants
Primary outcome timeframe
Mid-Cycle Baseline to Mid-Menstrual Samples
Results posted on
2011-08-23
Participant Flow
Participant milestones
| Measure |
Tampon With GML
Regular and Super Tampon with GML added to the cover
|
Tampon Without GML
Regular and Super Tampon without GML added to the cover
|
Tampon Normally Used
Type and Size of Tampon Normally Used by Subjects
|
|---|---|---|---|
|
Overall Study
STARTED
|
162
|
159
|
161
|
|
Overall Study
COMPLETED
|
144
|
143
|
147
|
|
Overall Study
NOT COMPLETED
|
18
|
16
|
14
|
Reasons for withdrawal
| Measure |
Tampon With GML
Regular and Super Tampon with GML added to the cover
|
Tampon Without GML
Regular and Super Tampon without GML added to the cover
|
Tampon Normally Used
Type and Size of Tampon Normally Used by Subjects
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
5
|
8
|
8
|
|
Overall Study
Pregnancy
|
1
|
3
|
0
|
|
Overall Study
Inadequate Number of Tampons Used
|
7
|
2
|
3
|
Baseline Characteristics
Clinical Evaluation of Effects of an Investigational Tampon on Vaginal Microflora
Baseline characteristics by cohort
| Measure |
Tampon With GML
n=162 Participants
Regular and Super Tampon with GML added to the cover
|
Tampon Without GML
n=159 Participants
Regular and Super Tampon without GML added to the cover
|
Tampon Normally Used
n=161 Participants
Type and Size of Tampon Normally Used by Subjects
|
Total
n=482 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Customized
18 to 64 years, inclusive
|
162 Participants
n=5 Participants
|
159 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
482 Participants
n=4 Participants
|
|
Age, Customized
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Female
|
162 participants
n=5 Participants
|
159 participants
n=7 Participants
|
161 participants
n=5 Participants
|
482 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino (H/L)
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
140 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
430 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Other Pacific Islander (NH/OPI)
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
H/L & NH/OPI
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
17 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
141 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
412 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
162 participants
n=5 Participants
|
159 participants
n=7 Participants
|
161 participants
n=5 Participants
|
482 participants
n=4 Participants
|
|
Weight 39-169 kg, inclusive
|
162 Participants
n=5 Participants
|
159 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
482 Participants
n=4 Participants
|
|
Height 143-148 cm, inclusive
|
162 Participants
n=5 Participants
|
159 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
482 Participants
n=4 Participants
|
|
Body Mass Index 15-54, inclusive
|
162 Participants
n=5 Participants
|
159 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
482 Participants
n=4 Participants
|
|
Average Cycle 17-35 Days, inclusive
|
162 Participants
n=5 Participants
|
159 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
482 Participants
n=4 Participants
|
|
Average Flow 3-10 Days, inclusive
Less than 3 Days
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Average Flow 3-10 Days, inclusive
3 to 10 Days, inclusive
|
162 Participants
n=5 Participants
|
159 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
482 Participants
n=4 Participants
|
|
Average Flow 3-10 Days, inclusive
More than 10 Days
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Number of Pregnancies Less than 14
|
162 Participants
n=5 Participants
|
159 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
482 Participants
n=4 Participants
|
|
Years of Tampon Use
Less than 1 Year
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Years of Tampon Use
1 Year
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Years of Tampon Use
2 to 34 Years, inclusive
|
161 Participants
n=5 Participants
|
158 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
479 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Mid-Cycle Baseline to Mid-Menstrual SamplesPopulation: 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.
Percentage of subjects showing unfavorable changes of at least 1-log in lactobacilli (decrease), C. albicans (increase), or G. vaginalis (increase)
Outcome measures
| Measure |
Tampon With GML
n=129 Participants
Regular and Super Tampon with GML added to the cover
|
Tampon Without GML
n=140 Participants
Regular and Super Tampon without GML added to the cover
|
Tampon Normally Used
n=141 Participants
Type and Size of Tampon Normally Used by Subjects
|
|---|---|---|---|
|
Percentage of Subjects Showing Unfavorable Changes in Primary Microflora
|
52.7 Percentage of Participants
|
52.9 Percentage of Participants
|
60.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Mid-Cycle Baseline to Post-Menstrual SamplesPopulation: 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.
Percentage of subjects showing unfavorable changes of at least 1-log in lactobacilli (decrease), C. albicans (increase), or G. vaginalis (increase)
Outcome measures
| Measure |
Tampon With GML
n=136 Participants
Regular and Super Tampon with GML added to the cover
|
Tampon Without GML
n=140 Participants
Regular and Super Tampon without GML added to the cover
|
Tampon Normally Used
n=141 Participants
Type and Size of Tampon Normally Used by Subjects
|
|---|---|---|---|
|
Percentage of Subjects Showing Unfavorable Changes in Primary Microflora
|
31.6 Percentage of Participants
|
34.3 Percentage of Participants
|
36.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: During MensesPopulation: 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.
Percentage of subjects with selected relevant microorganisms in tampons during menses
Outcome measures
| Measure |
Tampon With GML
n=130 Participants
Regular and Super Tampon with GML added to the cover
|
Tampon Without GML
n=140 Participants
Regular and Super Tampon without GML added to the cover
|
Tampon Normally Used
n=141 Participants
Type and Size of Tampon Normally Used by Subjects
|
|---|---|---|---|
|
Percentage of Subjects With Selected Microflora in Tampons
Lactobacilli
|
89.2 Percentage of Participants
|
85.0 Percentage of Participants
|
85.1 Percentage of Participants
|
|
Percentage of Subjects With Selected Microflora in Tampons
C. albicans
|
16.2 Percentage of Participants
|
12.1 Percentage of Participants
|
19.1 Percentage of Participants
|
|
Percentage of Subjects With Selected Microflora in Tampons
G. vaginalis
|
27.7 Percentage of Participants
|
43.6 Percentage of Participants
|
46.1 Percentage of Participants
|
|
Percentage of Subjects With Selected Microflora in Tampons
E. coli
|
28.5 Percentage of Participants
|
41.4 Percentage of Participants
|
34.8 Percentage of Participants
|
|
Percentage of Subjects With Selected Microflora in Tampons
Staphylococcus aureus
|
12.3 Percentage of Participants
|
17.9 Percentage of Participants
|
13.5 Percentage of Participants
|
|
Percentage of Subjects With Selected Microflora in Tampons
Group B Streptococcus
|
26.9 Percentage of Participants
|
22.1 Percentage of Participants
|
25.5 Percentage of Participants
|
|
Percentage of Subjects With Selected Microflora in Tampons
Enterococcus sp.
|
46.2 Percentage of Participants
|
37.9 Percentage of Participants
|
40.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: During MensesPopulation: 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.
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.
Outcome measures
| Measure |
Tampon With GML
n=130 Participants
Regular and Super Tampon with GML added to the cover
|
Tampon Without GML
n=140 Participants
Regular and Super Tampon without GML added to the cover
|
Tampon Normally Used
n=141 Participants
Type and Size of Tampon Normally Used by Subjects
|
|---|---|---|---|
|
Abundance of Selected Microflora in Tampons
Lactobacilli
|
5.5 CFU/gm
Standard Deviation 1.4
|
6.0 CFU/gm
Standard Deviation 1.2
|
6.0 CFU/gm
Standard Deviation 1.2
|
|
Abundance of Selected Microflora in Tampons
C. albicans
|
3.3 CFU/gm
Standard Deviation 1.3
|
3.7 CFU/gm
Standard Deviation 1.9
|
3.9 CFU/gm
Standard Deviation 1.5
|
|
Abundance of Selected Microflora in Tampons
G. vaginalis
|
6.2 CFU/gm
Standard Deviation 1.5
|
6.6 CFU/gm
Standard Deviation 1.2
|
6.3 CFU/gm
Standard Deviation 1.3
|
|
Abundance of Selected Microflora in Tampons
E. coli
|
4.8 CFU/gm
Standard Deviation 1.9
|
4.7 CFU/gm
Standard Deviation 2.0
|
5.1 CFU/gm
Standard Deviation 2.2
|
|
Abundance of Selected Microflora in Tampons
Staphylococcus aureus
|
5.6 CFU/gm
Standard Deviation 1.9
|
4.8 CFU/gm
Standard Deviation 1.7
|
4.7 CFU/gm
Standard Deviation 1.2
|
|
Abundance of Selected Microflora in Tampons
Group B Streptococcus
|
6.6 CFU/gm
Standard Deviation 1.7
|
6.9 CFU/gm
Standard Deviation 1.2
|
6.7 CFU/gm
Standard Deviation 1.6
|
|
Abundance of Selected Microflora in Tampons
Enterococcus sp.
|
5.1 CFU/gm
Standard Deviation 1.5
|
5.0 CFU/gm
Standard Deviation 1.4
|
5.3 CFU/gm
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Mid-Cycle Baseline to Mid-Menstrual SamplesPopulation: 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.
Percentage of subjects who showed a change in Nugent score from a score of \</= 3 to a score of \>/= 4.
Outcome measures
| Measure |
Tampon With GML
n=129 Participants
Regular and Super Tampon with GML added to the cover
|
Tampon Without GML
n=140 Participants
Regular and Super Tampon without GML added to the cover
|
Tampon Normally Used
n=141 Participants
Type and Size of Tampon Normally Used by Subjects
|
|---|---|---|---|
|
Changes in Nugent Score
|
17.7 Percentage of Participants
|
19.3 Percentage of Participants
|
24.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: Mid-Cycle Baseline to Post-Menstrual SamplesPopulation: 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.
Percentage of subjects who showed a change in Nugent score from a score of \</= 3 to a score of \>/= 4.
Outcome measures
| Measure |
Tampon With GML
n=136 Participants
Regular and Super Tampon with GML added to the cover
|
Tampon Without GML
n=140 Participants
Regular and Super Tampon without GML added to the cover
|
Tampon Normally Used
n=141 Participants
Type and Size of Tampon Normally Used by Subjects
|
|---|---|---|---|
|
Changes in Nugent Score
|
5.9 Percentage of Participants
|
12.9 Percentage of Participants
|
10.6 Percentage of Participants
|
Adverse Events
Tampon With GML
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Tampon Without GML
Serious events: 3 serious events
Other events: 17 other events
Deaths: 0 deaths
Tampon Normally Used
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tampon With GML
n=162 participants at risk
Regular and Super Tampon with GML added to the cover
|
Tampon Without GML
n=159 participants at risk
Regular and Super Tampon without GML added to the cover
|
Tampon Normally Used
n=161 participants at risk
Type and Size of Tampon Normally Used by Subjects
|
|---|---|---|---|
|
Reproductive system and breast disorders
Pregnancy
|
0.62%
1/162 • Up to 35 days
One Menstrual Cycle
|
1.9%
3/159 • Up to 35 days
One Menstrual Cycle
|
0.00%
0/161 • Up to 35 days
One Menstrual Cycle
|
Other adverse events
| Measure |
Tampon With GML
n=162 participants at risk
Regular and Super Tampon with GML added to the cover
|
Tampon Without GML
n=159 participants at risk
Regular and Super Tampon without GML added to the cover
|
Tampon Normally Used
n=161 participants at risk
Type and Size of Tampon Normally Used by Subjects
|
|---|---|---|---|
|
Reproductive system and breast disorders
Reproductive System Discomfort
|
6.2%
10/162 • Up to 35 days
One Menstrual Cycle
|
6.3%
10/159 • Up to 35 days
One Menstrual Cycle
|
1.2%
2/161 • Up to 35 days
One Menstrual Cycle
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Discomfort
|
1.9%
3/162 • Up to 35 days
One Menstrual Cycle
|
2.5%
4/159 • Up to 35 days
One Menstrual Cycle
|
3.7%
6/161 • Up to 35 days
One Menstrual Cycle
|
|
Nervous system disorders
Nervous System Discomfort
|
1.2%
2/162 • Up to 35 days
One Menstrual Cycle
|
1.9%
3/159 • Up to 35 days
One Menstrual Cycle
|
2.5%
4/161 • Up to 35 days
One Menstrual Cycle
|
|
General disorders
Dental Pain or Procedure
|
0.62%
1/162 • Up to 35 days
One Menstrual Cycle
|
0.63%
1/159 • Up to 35 days
One Menstrual Cycle
|
1.2%
2/161 • Up to 35 days
One Menstrual Cycle
|
|
Gastrointestinal disorders
Gastrointestinal Discomfort
|
0.62%
1/162 • Up to 35 days
One Menstrual Cycle
|
0.63%
1/159 • Up to 35 days
One Menstrual Cycle
|
0.00%
0/161 • Up to 35 days
One Menstrual Cycle
|
|
Injury, poisoning and procedural complications
Injuries
|
1.2%
2/162 • Up to 35 days
One Menstrual Cycle
|
0.63%
1/159 • Up to 35 days
One Menstrual Cycle
|
0.62%
1/161 • Up to 35 days
One Menstrual Cycle
|
Additional Information
Joyce Hauze, RPS Senior Specialist, Clinical Research Operations
Johnson & Johnson Consumer and Personal Products Worldwide
Phone: 928-277-0715
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee No paper that incorporates Sponsor Confidential Information will be submitted for publication without Sponsor's prior written consent. The Institution will provide Sponsor with at least sixty (60) days for review of a manuscript, and if requested in writing, the Institution and Principal Investigators will withhold such publication for up to an additional sixty (60) days to allow for filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER