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Trial Outcomes & Findings for In-use Study of Four Different Tampons (NCT NCT03478371)

NCT ID: NCT03478371

Last Updated: 2019-08-26

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

94 participants

Primary outcome timeframe

within 72 hours last tampon use

Results posted on

2019-08-26

Participant Flow

Participant milestones

Participant milestones
Measure
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.
Overall Study
STARTED
94
Overall Study
Received Tampon D
91
Overall Study
Received Tampon M
92
Overall Study
Recived Tampon T
90
Overall Study
Received Tampon V
91
Overall Study
COMPLETED
89
Overall Study
NOT COMPLETED
5

Reasons for withdrawal

Reasons for withdrawal
Measure
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.
Overall Study
non-compliance
1
Overall Study
Lost to Follow-up
4

Baseline Characteristics

In-use Study of Four Different Tampons

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Overall Study
n=94 Participants
This was a single center, double-blind 4 treatment, 4 period cross-over design. Each participant received each test product for one menstrual cycle.
Age, Continuous
33.4 years
n=5 Participants
Sex: Female, Male
Female
94 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
92 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race/Ethnicity, Customized
American Indian or Alaskan Native
2 Participants
n=5 Participants
Race/Ethnicity, Customized
Asian Indian
0 Participants
n=5 Participants
Race/Ethnicity, Customized
Asian Oriental
2 Participants
n=5 Participants
Race/Ethnicity, Customized
Black
36 Participants
n=5 Participants
Race/Ethnicity, Customized
Caucasian
51 Participants
n=5 Participants
Race/Ethnicity, Customized
Mutli-racial
0 Participants
n=5 Participants
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
0 Participants
n=5 Participants
Race/Ethnicity, Customized
Other
3 Participants
n=5 Participants

PRIMARY outcome

Timeframe: within 72 hours last tampon use

Population: 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.

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

Outcome measures

Outcome measures
Measure
Marketed Tampon D
n=91 Participants
Regular absorbency tampon tampon D: regular absorbency tampon
Marketed Tampon M
n=92 Participants
Regular absorbency tampon tampon M: regular absorbency tampon
Marketed Tampon T
n=90 Participants
Regular absorbency tampon tampon T: regular absorbency tampon
Marketed Tampon V
n=91 Participants
Regular absorbency tampon tampon V: regular absorbency tampon
Tolerance of Tampon Wear Via Physician Assessment of Vaginal Health
Erythema score greater than 0
0 Participants
0 Participants
0 Participants
0 Participants
Tolerance of Tampon Wear Via Physician Assessment of Vaginal Health
Presence of Ulcerations
0 Participants
0 Participants
0 Participants
0 Participants
Tolerance of Tampon Wear Via Physician Assessment of Vaginal Health
Presence of Abrasions
0 Participants
0 Participants
0 Participants
0 Participants
Tolerance of Tampon Wear Via Physician Assessment of Vaginal Health
Abnormal Vaginal Discharge
0 Participants
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: within 72 hours last tampon use

Population: 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.

Vaginal pH

Outcome measures

Outcome measures
Measure
Marketed Tampon D
n=91 Participants
Regular absorbency tampon tampon D: regular absorbency tampon
Marketed Tampon M
n=92 Participants
Regular absorbency tampon tampon M: regular absorbency tampon
Marketed Tampon T
n=90 Participants
Regular absorbency tampon tampon T: regular absorbency tampon
Marketed Tampon V
n=91 Participants
Regular absorbency tampon tampon V: regular absorbency tampon
Vaginal pH
4.43 pH
Standard Error 0.053
4.46 pH
Standard Error 0.061
4.40 pH
Standard Error 0.055
4.44 pH
Standard Error 0.061

SECONDARY outcome

Timeframe: 4 months

Population: 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.

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

Outcome measures

Outcome measures
Measure
Marketed Tampon D
n=91 Participants
Regular absorbency tampon tampon D: regular absorbency tampon
Marketed Tampon M
n=92 Participants
Regular absorbency tampon tampon M: regular absorbency tampon
Marketed Tampon T
n=90 Participants
Regular absorbency tampon tampon T: regular absorbency tampon
Marketed Tampon V
n=91 Participants
Regular absorbency tampon tampon V: regular absorbency tampon
Subject Comfort Diary
81.7 units on a scale
Standard Error 2.60
78.5 units on a scale
Standard Error 2.56
74.0 units on a scale
Standard Error 2.58
73.2 units on a scale
Standard Error 2.57

SECONDARY outcome

Timeframe: 4 months

Population: 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.

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

Outcome measures

Outcome measures
Measure
Marketed Tampon D
n=91 Participants
Regular absorbency tampon tampon D: regular absorbency tampon
Marketed Tampon M
n=92 Participants
Regular absorbency tampon tampon M: regular absorbency tampon
Marketed Tampon T
n=90 Participants
Regular absorbency tampon tampon T: regular absorbency tampon
Marketed Tampon V
n=91 Participants
Regular absorbency tampon tampon V: regular absorbency tampon
Subject Comfort Questionnaire
78.4 units on a scale
Standard Error 3.17
71.5 units on a scale
Standard Error 3.17
66.5 units on a scale
Standard Error 3.17
60.9 units on a scale
Standard Error 3.15

Adverse Events

Marketed Tampon D

Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths

Marketed Tampon M

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Marketed Tampon T

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Marketed Tampon V

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Marketed Tampon D
n=91 participants at risk
Regular absorbency tampon tampon D: regular absorbency tampon
Marketed Tampon M
n=92 participants at risk
Regular absorbency tampon tampon M: regular absorbency tampon
Marketed Tampon T
n=90 participants at risk
Regular absorbency tampon tampon T: regular absorbency tampon
Marketed Tampon V
n=91 participants at risk
Regular absorbency tampon tampon V: regular absorbency tampon
Psychiatric disorders
Post-traumatic stress disorder
1.1%
1/91 • Number of events 1 • six months
0.00%
0/92 • six months
0.00%
0/90 • six months
0.00%
0/91 • six months

Other adverse events

Adverse event data not reported

Additional Information

Jan Streicher-Scott, PhD, RPh

Procter & Gamble Co

Phone: 513-634-5584

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: OTHER