Trial Outcomes & Findings for A 3-way Crossover Clinical Investigation to Assess the Performance of Two Different Sized Polyurethane Condoms Versus a Latex Condom in Healthy Monogamous Couples. (NCT NCT06557499)
NCT ID: NCT06557499
Last Updated: 2026-07-24
Results Overview
The total clinical failure rate (combined breakage and slippage) of PU male test condom (Test condom 1) compared to the NRL male control condom. Clinical failure rate is calculated as the number of condoms with at least 1 acute clinical failure event divided by the number of condoms used during intercourse, reported as a percentage. Clinical failure events, defined in ISO 29943-1:2017, reported by participants.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
598 participants
Primary outcome timeframe
within 8 hours following each coital act for each condom use
Results posted on
2026-07-24
Participant Flow
Participant milestones
| Measure |
Sequence 1
Sequence 1: Test Condom 1-Test Condom 2-Control Condom
|
Sequence 2
Sequence 2: Test Condom 1-Control Condom-Test Condom 2
|
Sequence 3
Sequence 3: Test Condom 2-Test Condom 1-Control Condom
|
Sequence 4
Sequence 4: Test Condom 2-Control Condom-Test Condom 1
|
Sequence 5
Sequence 5: Control Condom-Test Condom 1-Test Condom 2
|
Sequence 6
Sequance 6: Control Condom-Test Condom 2-Test Condom 1
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
51
|
49
|
50
|
49
|
50
|
50
|
|
Overall Study
Treated
|
48
|
44
|
46
|
48
|
47
|
50
|
|
Overall Study
Treated (Male Participants)
|
48
|
44
|
46
|
48
|
47
|
50
|
|
Overall Study
Treated (Female Participants)
|
48
|
44
|
46
|
48
|
47
|
50
|
|
Overall Study
COMPLETED
|
45
|
38
|
41
|
41
|
42
|
43
|
|
Overall Study
NOT COMPLETED
|
6
|
11
|
9
|
8
|
8
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.
Baseline characteristics by cohort
| Measure |
Sequence 1
n=96 Participants
Sequence 1: Test Condom 1-Test Condom 2-Control Condom
|
Sequence 2
n=88 Participants
Sequence 2: Test Condom 1-Control Condom-Test Condom 2
|
Sequence 3
n=92 Participants
Sequence 3: Test Condom 2-Test Condom 1-Control Condom
|
Sequence 4
n=96 Participants
Sequence 4: Test Condom 2-Control Condom-Test Condom 1
|
Sequence 5
n=94 Participants
Sequence 5: Control Condom-Test Condom 1-Test Condom 2
|
Sequence 6
n=100 Participants
Sequance 6: Control Condom-Test Condom 2-Test Condom 1
|
Total
n=566 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
Male Age
|
34.0 Years
STANDARD_DEVIATION 7.53 • n=48 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.
|
31.5 Years
STANDARD_DEVIATION 5.33 • n=44 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.
|
33.1 Years
STANDARD_DEVIATION 7.20 • n=46 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.
|
33.5 Years
STANDARD_DEVIATION 6.63 • n=48 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.
|
33.0 Years
STANDARD_DEVIATION 6.54 • n=47 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.
|
31.6 Years
STANDARD_DEVIATION 6.45 • n=50 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.
|
32.8 Years
STANDARD_DEVIATION 6.67 • n=283 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.
|
|
Age, Continuous
Female Age
|
32.3 Years
STANDARD_DEVIATION 7.23 • n=48 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.
|
30.0 Years
STANDARD_DEVIATION 5.19 • n=44 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.
|
31.5 Years
STANDARD_DEVIATION 7.33 • n=46 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.
|
33.5 Years
STANDARD_DEVIATION 6.70 • n=48 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.
|
31.9 Years
STANDARD_DEVIATION 6.82 • n=47 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.
|
30.5 Years
STANDARD_DEVIATION 5.68 • n=50 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.
|
31.6 Years
STANDARD_DEVIATION 6.58 • n=283 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.
|
|
Sex: Female, Male
Female
|
48 Participants
n=96 Participants
|
44 Participants
n=88 Participants
|
46 Participants
n=92 Participants
|
48 Participants
n=96 Participants
|
47 Participants
n=94 Participants
|
50 Participants
n=100 Participants
|
283 Participants
n=566 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=96 Participants
|
44 Participants
n=88 Participants
|
46 Participants
n=92 Participants
|
48 Participants
n=96 Participants
|
47 Participants
n=94 Participants
|
50 Participants
n=100 Participants
|
283 Participants
n=566 Participants
|
|
Race/Ethnicity, Customized
White, not Hispanic/Latino-Male
|
25 participants (can choose multiple)
n=48 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
27 participants (can choose multiple)
n=44 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
27 participants (can choose multiple)
n=46 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
24 participants (can choose multiple)
n=48 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
21 participants (can choose multiple)
n=47 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
30 participants (can choose multiple)
n=50 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
154 participants (can choose multiple)
n=283 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
|
Race/Ethnicity, Customized
Hispanic/Latino- Male
|
10 participants (can choose multiple)
n=48 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
8 participants (can choose multiple)
n=44 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
13 participants (can choose multiple)
n=46 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
14 participants (can choose multiple)
n=48 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
15 participants (can choose multiple)
n=47 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
13 participants (can choose multiple)
n=50 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
73 participants (can choose multiple)
n=283 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
|
Race/Ethnicity, Customized
African American- Male
|
4 participants (can choose multiple)
n=48 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
4 participants (can choose multiple)
n=44 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
2 participants (can choose multiple)
n=46 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
3 participants (can choose multiple)
n=48 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
1 participants (can choose multiple)
n=47 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
4 participants (can choose multiple)
n=50 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
18 participants (can choose multiple)
n=283 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander-Male
|
9 participants (can choose multiple)
n=48 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
11 participants (can choose multiple)
n=44 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
4 participants (can choose multiple)
n=46 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
8 participants (can choose multiple)
n=48 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
9 participants (can choose multiple)
n=47 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
8 participants (can choose multiple)
n=50 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
49 participants (can choose multiple)
n=283 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
|
Race/Ethnicity, Customized
Native American- Male
|
1 participants (can choose multiple)
n=48 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
1 participants (can choose multiple)
n=44 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
1 participants (can choose multiple)
n=46 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
0 participants (can choose multiple)
n=48 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
0 participants (can choose multiple)
n=47 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
1 participants (can choose multiple)
n=50 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
4 participants (can choose multiple)
n=283 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
|
Race/Ethnicity, Customized
Other- Male
|
3 participants (can choose multiple)
n=48 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
0 participants (can choose multiple)
n=44 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
0 participants (can choose multiple)
n=46 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
2 participants (can choose multiple)
n=48 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
1 participants (can choose multiple)
n=47 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
0 participants (can choose multiple)
n=50 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
6 participants (can choose multiple)
n=283 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
|
Race/Ethnicity, Customized
White, not Hispanic/Latino- Female
|
24 participants (can choose multiple)
n=48 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
18 participants (can choose multiple)
n=44 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
29 participants (can choose multiple)
n=46 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
22 participants (can choose multiple)
n=48 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
23 participants (can choose multiple)
n=47 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
28 participants (can choose multiple)
n=50 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
144 participants (can choose multiple)
n=283 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
|
Race/Ethnicity, Customized
Hispanic/Latino- Female
|
13 participants (can choose multiple)
n=48 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
11 participants (can choose multiple)
n=44 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
12 participants (can choose multiple)
n=46 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
15 participants (can choose multiple)
n=48 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
15 participants (can choose multiple)
n=47 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
14 participants (can choose multiple)
n=50 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
80 participants (can choose multiple)
n=283 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
|
Race/Ethnicity, Customized
African American- Female
|
4 participants (can choose multiple)
n=48 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
6 participants (can choose multiple)
n=44 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
1 participants (can choose multiple)
n=46 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
4 participants (can choose multiple)
n=48 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
1 participants (can choose multiple)
n=47 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
2 participants (can choose multiple)
n=50 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
18 participants (can choose multiple)
n=283 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander-Female
|
9 participants (can choose multiple)
n=48 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
11 participants (can choose multiple)
n=44 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
6 participants (can choose multiple)
n=46 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
9 participants (can choose multiple)
n=48 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
10 participants (can choose multiple)
n=47 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
10 participants (can choose multiple)
n=50 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
55 participants (can choose multiple)
n=283 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
|
Race/Ethnicity, Customized
Native American- Female
|
2 participants (can choose multiple)
n=48 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
1 participants (can choose multiple)
n=44 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
0 participants (can choose multiple)
n=46 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
0 participants (can choose multiple)
n=48 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
0 participants (can choose multiple)
n=47 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
0 participants (can choose multiple)
n=50 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
3 participants (can choose multiple)
n=283 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
|
Race/Ethnicity, Customized
Other- Female
|
2 participants (can choose multiple)
n=48 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
1 participants (can choose multiple)
n=44 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
2 participants (can choose multiple)
n=46 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
0 participants (can choose multiple)
n=48 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
2 participants (can choose multiple)
n=47 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
2 participants (can choose multiple)
n=50 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
9 participants (can choose multiple)
n=283 Participants • 283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.Participants could choose multiple ethnicity options, for example, if they were of mixed race.
|
PRIMARY outcome
Timeframe: within 8 hours following each coital act for each condom usePopulation: 283 (Overall Number of Participants Analyzed) is the number of couples in Full Analysis Set population
The total clinical failure rate (combined breakage and slippage) of PU male test condom (Test condom 1) compared to the NRL male control condom. Clinical failure rate is calculated as the number of condoms with at least 1 acute clinical failure event divided by the number of condoms used during intercourse, reported as a percentage. Clinical failure events, defined in ISO 29943-1:2017, reported by participants.
Outcome measures
| Measure |
Test Condom 1: Polyurethane (PU) 57 mm
n=283 Participants
Following randomisation, couples received a carton of Test Condom 1 (polyurethane \[PU\], 57 mm) for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
Control Condom: Natural Rubber Latex (NRL) 57 mm
n=283 Participants
Following randomisation, couples received a carton of Control condom: Natural Rubber Latex (NRL) 57 for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
Control Condom: Natural Rubber Latex (NRL) 57 mm
Following randomisation, couples received a carton of Test Condom 2 (polyurethane \[PU\], 63 mm) for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
|---|---|---|---|
|
Total Clinical Failure Rate of Polyurethane (PU) Male (Test Condom 1: PU 57 mm) Condom Compared to Control Condom: Natural Rubber Latex (NRL) 57 mm Male Condom.
|
3.08 % Clinical failure
Interval 1.71 to 4.45
|
2.48 % Clinical failure
Interval 1.23 to 3.73
|
—
|
PRIMARY outcome
Timeframe: within 8 hours following each coital act for each condom usePopulation: 283 (Overall Number of Participants Analysed) is the number of couples in Full Analysis Set population
The total clinical failure rate (combined breakage and slippage) of PU male test condom (Test condom 2) compared to the NRL male control condom. Clinical failure rate is calculated as the number of condoms with at least 1 acute clinical failure event divided by the number of condoms used during intercourse, reported as a percentage. Clinical failure events, defined in ISO 29943-1:2017, reported by participants.
Outcome measures
| Measure |
Test Condom 1: Polyurethane (PU) 57 mm
n=283 Participants
Following randomisation, couples received a carton of Test Condom 1 (polyurethane \[PU\], 57 mm) for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
Control Condom: Natural Rubber Latex (NRL) 57 mm
n=283 Participants
Following randomisation, couples received a carton of Control condom: Natural Rubber Latex (NRL) 57 for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
Control Condom: Natural Rubber Latex (NRL) 57 mm
Following randomisation, couples received a carton of Test Condom 2 (polyurethane \[PU\], 63 mm) for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
|---|---|---|---|
|
Total Clinical Failure Rate of Polyurethane (PU) Male (Test Condom 2: PU 63 mm) Condom Compared to Control Condom: Natural Rubber Latex (NRL) 57 mm Male Condom.
|
2.97 % clinical failure.
Interval 1.61 to 4.33
|
2.48 % clinical failure.
Interval 1.23 to 3.73
|
—
|
SECONDARY outcome
Timeframe: within 8 hours following each coital act for each condom usePopulation: 283 (Overall Number of Participants Analyzed) is the number of couples in Full Analysis Set population
The total clinical breakage rate of the PU male test condom (Test condom 1) compared to the NRL male control condom when used during vaginal intercourse. The total clinical breakage rate is determined from the number of condoms broken or torn during vaginal intercourse or withdrawal from the vagina divided by the number of condoms used during intercourse, reported as a percentage.
Outcome measures
| Measure |
Test Condom 1: Polyurethane (PU) 57 mm
n=283 Participants
Following randomisation, couples received a carton of Test Condom 1 (polyurethane \[PU\], 57 mm) for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
Control Condom: Natural Rubber Latex (NRL) 57 mm
n=283 Participants
Following randomisation, couples received a carton of Control condom: Natural Rubber Latex (NRL) 57 for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
Control Condom: Natural Rubber Latex (NRL) 57 mm
Following randomisation, couples received a carton of Test Condom 2 (polyurethane \[PU\], 63 mm) for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
|---|---|---|---|
|
Clinical Breakage Rate of PU Male Test Condom 1 Compared to NRL Male Control Condom
|
0.91 % clinical breakage rate
Interval 0.3 to 1.53
|
1.0 % clinical breakage rate
Interval 0.37 to 1.64
|
—
|
SECONDARY outcome
Timeframe: within 8 hours following each coital act for each condom usePopulation: 283 (Overall Number of Participants Analyzed) is the number of couples in Full Analysis Set population
The total clinical slippage rate of the PU male test condom (Test condom 1) compared to the NRL male control condom when used during vaginal intercourse. The total clinical slippage rate is determined from the number of condoms that slipped completely off the penis during intercourse or withdrawal from the vagina, divided by the number of condoms used during vaginal intercourse, reported as a percentage.
Outcome measures
| Measure |
Test Condom 1: Polyurethane (PU) 57 mm
n=283 Participants
Following randomisation, couples received a carton of Test Condom 1 (polyurethane \[PU\], 57 mm) for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
Control Condom: Natural Rubber Latex (NRL) 57 mm
n=283 Participants
Following randomisation, couples received a carton of Control condom: Natural Rubber Latex (NRL) 57 for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
Control Condom: Natural Rubber Latex (NRL) 57 mm
Following randomisation, couples received a carton of Test Condom 2 (polyurethane \[PU\], 63 mm) for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
|---|---|---|---|
|
Clinical Slippage Rate of PU Male Test Condom 1 Compared to NRL Male Control Condom
|
2.87 % clinical slippage rate
Interval 1.5 to 4.24
|
1.05 % clinical slippage rate
Interval 0.09 to 2.02
|
—
|
SECONDARY outcome
Timeframe: within 8 hours following each coital act for each condom usePopulation: 283 (Overall Number of Participants Analyzed) is the number of couples in Full Analysis Set population
The total clinical breakage rate of the PU male test condom (Test condom 2) compared to the NRL male control condom when used during vaginal intercourse. The total clinical breakage rate is determined from the number of condoms broken or torn during vaginal intercourse or withdrawal from the vagina divided by the number of condoms used during intercourse, reported as a percentage.
Outcome measures
| Measure |
Test Condom 1: Polyurethane (PU) 57 mm
n=283 Participants
Following randomisation, couples received a carton of Test Condom 1 (polyurethane \[PU\], 57 mm) for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
Control Condom: Natural Rubber Latex (NRL) 57 mm
n=283 Participants
Following randomisation, couples received a carton of Control condom: Natural Rubber Latex (NRL) 57 for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
Control Condom: Natural Rubber Latex (NRL) 57 mm
Following randomisation, couples received a carton of Test Condom 2 (polyurethane \[PU\], 63 mm) for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
|---|---|---|---|
|
Clinical Breakage Rate of PU Male Test Condom 2 Compared to NRL Male Control Condom
|
0.13 % clinical breakage rate
Interval -0.05 to 0.31
|
1.0 % clinical breakage rate
Interval 0.37 to 1.64
|
—
|
SECONDARY outcome
Timeframe: within 8 hours following each coital act for each condom usePopulation: 283 (Overall Number of Participants Analyzed) is the number of couples in Full Analysis Set population
The total clinical slippage rate of the PU male test condom (Test condom 2) compared to the NRL male control condom when used during vaginal intercourse.
Outcome measures
| Measure |
Test Condom 1: Polyurethane (PU) 57 mm
n=283 Participants
Following randomisation, couples received a carton of Test Condom 1 (polyurethane \[PU\], 57 mm) for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
Control Condom: Natural Rubber Latex (NRL) 57 mm
n=283 Participants
Following randomisation, couples received a carton of Control condom: Natural Rubber Latex (NRL) 57 for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
Control Condom: Natural Rubber Latex (NRL) 57 mm
Following randomisation, couples received a carton of Test Condom 2 (polyurethane \[PU\], 63 mm) for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
|---|---|---|---|
|
Clinical Slippage Rate of PU Male Test Condom 2 Compared to NRL Male Control Condom
|
2.43 % clinical slippage rate
Interval 1.16 to 3.71
|
1.05 % clinical slippage rate
Interval 0.09 to 2.02
|
—
|
SECONDARY outcome
Timeframe: within 8 hours following each coital act for each condom usePopulation: 283 (Overall Number of Participants Analyzed) is the number of couples in Full Analysis Set population
The total non-clinical breakage for each of the PU male test condom and the NRL male control condom when used during vaginal intercourse.
Outcome measures
| Measure |
Test Condom 1: Polyurethane (PU) 57 mm
n=283 Participants
Following randomisation, couples received a carton of Test Condom 1 (polyurethane \[PU\], 57 mm) for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
Control Condom: Natural Rubber Latex (NRL) 57 mm
n=283 Participants
Following randomisation, couples received a carton of Control condom: Natural Rubber Latex (NRL) 57 for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
Control Condom: Natural Rubber Latex (NRL) 57 mm
n=283 Participants
Following randomisation, couples received a carton of Test Condom 2 (polyurethane \[PU\], 63 mm) for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
|---|---|---|---|
|
Non-clinical Breakage Rate for Each of the PU Male Condoms (Test Condom 1 and Test Condom 2) and the NRL Male Control Condom.
|
18 Non-clinical breakage
|
6 Non-clinical breakage
|
11 Non-clinical breakage
|
SECONDARY outcome
Timeframe: within 8 hours following each coital act for each condom usePopulation: 283 (Overall Number of Participants Analyzed) is the number of couples in Full Analysis Set population
The total non-clinical slippage rate for each of the PU male test condoms and the NRL male control condom when used during vaginal intercourse.
Outcome measures
| Measure |
Test Condom 1: Polyurethane (PU) 57 mm
n=283 Participants
Following randomisation, couples received a carton of Test Condom 1 (polyurethane \[PU\], 57 mm) for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
Control Condom: Natural Rubber Latex (NRL) 57 mm
n=283 Participants
Following randomisation, couples received a carton of Control condom: Natural Rubber Latex (NRL) 57 for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
Control Condom: Natural Rubber Latex (NRL) 57 mm
n=283 Participants
Following randomisation, couples received a carton of Test Condom 2 (polyurethane \[PU\], 63 mm) for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
|---|---|---|---|
|
Non-clinical Slippage Respectively of Each PU Male Test Condom (Test Condom 1 and Test Condom 2) and the NRL Male Control Condom.
|
168 Number of non-clinical slippage
|
245 Number of non-clinical slippage
|
149 Number of non-clinical slippage
|
SECONDARY outcome
Timeframe: within 8 hours following each coital act for each condom usePopulation: Number of Participants Analyzed is total male and female who completed the relevant questionnaire of the FAS population
User acceptability, experience, and preference for each condom type will be evaluated through participant-perceived questions. Participant's experience on the use of each type of condoms \[Acceptability as assessed by participant perceived questionnaires-End of Condom Use Period Questionnaire (ECUPQ) (designed by following ISO 29943-1). ECUPQ uses a 10 point scale with 1 representing agreement 'to the least degree (not at all)' and 10 agree 'to the most degree'.
Outcome measures
| Measure |
Test Condom 1: Polyurethane (PU) 57 mm
n=502 Participants
Following randomisation, couples received a carton of Test Condom 1 (polyurethane \[PU\], 57 mm) for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
Control Condom: Natural Rubber Latex (NRL) 57 mm
n=512 Participants
Following randomisation, couples received a carton of Control condom: Natural Rubber Latex (NRL) 57 for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
Control Condom: Natural Rubber Latex (NRL) 57 mm
n=502 Participants
Following randomisation, couples received a carton of Test Condom 2 (polyurethane \[PU\], 63 mm) for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
|---|---|---|---|
|
User Acceptability/In-use Tolerability of the 2 PU Male Test Condoms (Test Condom 1 and Test Condom 2) and the NRL Male Control Condom.
Overall liking of each condom type assessed using Question 1.1 of ECUPQ (Male participants)
|
6.2 ECUPQ overall liking score (1-10)
Standard Deviation 2.57
|
6.6 ECUPQ overall liking score (1-10)
Standard Deviation 2.17
|
6.2 ECUPQ overall liking score (1-10)
Standard Deviation 2.36
|
|
User Acceptability/In-use Tolerability of the 2 PU Male Test Condoms (Test Condom 1 and Test Condom 2) and the NRL Male Control Condom.
Overall liking of each condom type assessed using Question 1.1 of ECUPQ (Female participants)
|
6.7 ECUPQ overall liking score (1-10)
Standard Deviation 2.39
|
6.9 ECUPQ overall liking score (1-10)
Standard Deviation 2.05
|
6.4 ECUPQ overall liking score (1-10)
Standard Deviation 2.26
|
Adverse Events
Test Condom 1: Polyurethane (PU) 57 mm- Male
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Test Condom 1: Polyurethane (PU) 57 mm- Female
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Test Condom 2: Polyurethane (PU) 63 mm- Male
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Test Condom 2: Polyurethane (PU) 63 mm- Female
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Control Condom: Natural Rubber Latex (NRL) 57 mm- Male
Serious events: 1 serious events
Other events: 6 other events
Deaths: 1 deaths
Control Condom: Natural Rubber Latex (NRL) 57 mm- Female
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Test Condom 1: Polyurethane (PU) 57 mm- Male
n=260 participants at risk
Following randomisation, couples received a carton of Test Condom 1 (polyurethane \[PU\], 57 mm) for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
Test Condom 1: Polyurethane (PU) 57 mm- Female
n=260 participants at risk
Following randomisation, couples received a carton of Test Condom 1 (polyurethane \[PU\], 57 mm) for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
Test Condom 2: Polyurethane (PU) 63 mm- Male
n=264 participants at risk
Following randomisation, couples received a carton of Test Condom 2 (polyurethane \[PU\], 63 mm) for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
Test Condom 2: Polyurethane (PU) 63 mm- Female
n=264 participants at risk
Following randomisation, couples received a carton of Test Condom 2 (polyurethane \[PU\], 63 mm) for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
Control Condom: Natural Rubber Latex (NRL) 57 mm- Male
n=266 participants at risk
Following randomisation, couples received a carton of Test Condom 2 (polyurethane \[PU\], 63 mm) for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
Control Condom: Natural Rubber Latex (NRL) 57 mm- Female
n=266 participants at risk
Following randomisation, couples received a carton of Test Condom 2 (polyurethane \[PU\], 63 mm) for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
|---|---|---|---|---|---|---|
|
Infections and infestations
appendicitis
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.38%
1/264 • Number of events 1 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.38%
1/266 • Number of events 1 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
|
Psychiatric disorders
suicide
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.38%
1/264 • Number of events 1 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.38%
1/266 • Number of events 1 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
Other adverse events
| Measure |
Test Condom 1: Polyurethane (PU) 57 mm- Male
n=260 participants at risk
Following randomisation, couples received a carton of Test Condom 1 (polyurethane \[PU\], 57 mm) for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
Test Condom 1: Polyurethane (PU) 57 mm- Female
n=260 participants at risk
Following randomisation, couples received a carton of Test Condom 1 (polyurethane \[PU\], 57 mm) for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
Test Condom 2: Polyurethane (PU) 63 mm- Male
n=264 participants at risk
Following randomisation, couples received a carton of Test Condom 2 (polyurethane \[PU\], 63 mm) for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
Test Condom 2: Polyurethane (PU) 63 mm- Female
n=264 participants at risk
Following randomisation, couples received a carton of Test Condom 2 (polyurethane \[PU\], 63 mm) for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
Control Condom: Natural Rubber Latex (NRL) 57 mm- Male
n=266 participants at risk
Following randomisation, couples received a carton of Test Condom 2 (polyurethane \[PU\], 63 mm) for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
Control Condom: Natural Rubber Latex (NRL) 57 mm- Female
n=266 participants at risk
Following randomisation, couples received a carton of Test Condom 2 (polyurethane \[PU\], 63 mm) for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Fungal infection
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
1.2%
3/260 • Number of events 3 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.38%
1/264 • Number of events 1 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
|
Infections and infestations
Lower respiratory tract
|
0.77%
2/260 • Number of events 2 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.77%
2/260 • Number of events 2 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.38%
1/264 • Number of events 1 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.38%
1/266 • Number of events 1 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.38%
1/260 • Number of events 1 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
|
Infections and infestations
Nasopharyngitis
|
0.38%
1/260 • Number of events 1 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.38%
1/260 • Number of events 1 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
1.9%
5/264 • Number of events 5 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.76%
2/264 • Number of events 2 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
1.1%
3/266 • Number of events 3 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
|
Infections and infestations
Varicella
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.38%
1/260 • Number of events 1 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.38%
1/264 • Number of events 1 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.38%
1/266 • Number of events 1 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
|
Infections and infestations
Influenza
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.38%
1/266 • Number of events 1 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.38%
1/264 • Number of events 1 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
|
Infections and infestations
Respiratory tract
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.38%
1/264 • Number of events 1 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
|
Infections and infestations
Upper respiratory tract
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.76%
2/264 • Number of events 2 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.76%
2/264 • Number of events 2 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.38%
1/266 • Number of events 1 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
|
Infections and infestations
Vulvovaginal mycotic
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.38%
1/266 • Number of events 1 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
|
Nervous system disorders
Seizure
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.38%
1/260 • Number of events 1 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.38%
1/260 • Number of events 1 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.38%
1/260 • Number of events 1 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.38%
1/266 • Number of events 1 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
|
General disorders
Pyrexia
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.38%
1/266 • Number of events 1 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
|
Investigations
Smear cervix abnormal
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.38%
1/266 • Number of events 1 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.38%
1/266 • Number of events 1 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.38%
1/266 • Number of events 1 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.38%
1/266 • Number of events 1 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
|
Surgical and medical procedures
Endodontic procedure
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.38%
1/264 • Number of events 1 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.38%
1/264 • Number of events 1 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.38%
1/260 • Number of events 1 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.38%
1/264 • Number of events 1 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.38%
1/264 • Number of events 1 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
|
Reproductive system and breast disorders
Penile discomfort
|
0.38%
1/260 • Number of events 2 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.38%
1/264 • Number of events 1 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
|
General disorders
Discomfort
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.38%
1/266 • Number of events 1 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.38%
1/264 • Number of events 1 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.38%
1/264 • Number of events 1 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
|
Vascular disorders
Hypertension
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/260 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/264 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.38%
1/266 • Number of events 1 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
0.00%
0/266 • From first use of study condom through end of the clinical investigation
Treatment emergent adverse events (TEAEs) were adverse events that started or worsened after first use of a study condom through end of study participation (up to approximately 5months). AEs were collected systematically via participant questionnaires and scheduled study visits and assessed by the delegated site staff for severity and relationship to the investigational products.TEAEs outlined here.
|
Additional Information
Clinical Study Manager
Reckitt Benckiser Health Limited
Phone: +44 (0)1482 326151
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Site/PI shall not register either a Clinical Study or the results of any Clinical Study on any publicly accessible clinical study registry without the prior written consent of the Sponsor. Publication of the results of a Clinical Study,whether in whole or in part, shall be within the sole and absolute discretion of the Sponsor, and the Site/PI/CRO shall not be entitled to publish any of the data or information arising during a Clinical Study without the prior written consent of the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER