Trial Outcomes & Findings for A Clinical Investigation to Assess the Effectiveness of Benzocaine in NRL Condoms in Healthy Adult Men Who Feel They Ejaculate Too Quickly During Vaginal Sex (NCT NCT05840172)
NCT ID: NCT05840172
Last Updated: 2026-05-07
Results Overview
Participants recorded the duration from vaginal entry to ejaculation for each condom use. The outcome was evaluated by the change from baseline with the Test Condom A compared to the Control NRL Condom, over a 4-week assessment period. This outcome was to measure the per participant's average IELT time per condom type. The Intravaginal Ejaculation Latency Time (IELT) is the duration from the start of vaginal entry (vaginal penetration into the female partner) until the start of intravaginal ejaculation (release of semen). It did not analyze all condom uses or sexual encounters as a unit, rather those were taken as an average per participant, in order to effectively run a Generalized Linear Mixed Model. This outcome measure data was collected and analyzed for 150 male participants.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
300 participants
Primary outcome timeframe
4 weeks for each assessment period (intervention duration)
Results posted on
2026-05-07
Participant Flow
218 couples were screened for eligibility at a clinical site in Germany. 150 of 218 couples (300 participants) were randomized. Of those not randomized, 68 couples were screen failures. Each couple was randomized to use condoms by sequence. The randomized sequences were A/B/Control, A/Control/B, B/A/Control, B/Control/A, Control/A/B, Control/B/A.
Participant milestones
| Measure |
A/B/Control
Participants assigned to use Test Condom A first followed by Test Condom B then Control NRL Condom.
After reporting at least 4 Intravaginal Ejaculation Latency Time (IELT) records (from vaginal entry to ejaculation), participants returned to the clinical site for collection of their next set of condoms. A 3-day washout period, where no test condom was used, was required before participants were supplied with condom type. Participants repeated the assessment period each to test all 3 condom types.
|
A/Control/B
Participants assigned to use Test Condom A first followed by Control NRL Condom then Test Condom B.
After reporting at least 4 IELT records (from vaginal entry to ejaculation), participants returned to the clinical site for collection of their next set of condoms. A 3-day washout period, where no test condom was used, was required before participants were supplied with condom type. Participants repeated the assessment period each to test all 3 condom types.
|
B/A/Control
Participants assigned to use Test Condom B first followed by Test Condom A then Control NRL Condom.
After reporting at least 4 IIELT records (from vaginal entry to ejaculation), participants returned to the clinical site for collection of their next set of condoms. A 3-day washout period, where no test condom was used, was required before participants were supplied with condom type. Participants repeated the assessment period each to test all 3 condom types.
|
B/Control/A
Participants assigned to use Test Condom B first followed by Control NRL Condom then Test Condom A.
After reporting at least 4 IELT records (from vaginal entry to ejaculation), participants returned to the clinical site for collection of their next set of condoms. A 3-day washout period, where no test condom was used, was required before participants were supplied with condom type. Participants repeated the assessment period each to test all 3 condom types.
|
Control/A/B
Participants assigned to use Control NRL Condom first followed by Test Condom A then Test Condom B.
After reporting at least 4 IELT records (from vaginal entry to ejaculation), participants returned to the clinical site for collection of their next set of condoms. A 3-day washout period, where no test condom was used, was required before participants were supplied with condom type. Participants repeated the assessment period each to test all 3 condom types.
|
Control/B/A
Participants assigned to use Control NRL Condom first followed by Test Condom B then Test Condom A.
After reporting at least 4 IELT records (from vaginal entry to ejaculation), participants returned to the clinical site for collection of their next set of condoms. A 3-day washout period, where no test condom was used, was required before participants were supplied with condom type. Participants repeated the assessment period each to test all 3 condom types.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
25
|
25
|
25
|
25
|
|
Overall Study
Male Participants
|
25
|
25
|
25
|
25
|
25
|
25
|
|
Overall Study
Female Participants
|
25
|
25
|
25
|
25
|
25
|
25
|
|
Overall Study
COMPLETED
|
24
|
22
|
25
|
23
|
25
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
0
|
2
|
0
|
1
|
Reasons for withdrawal
| Measure |
A/B/Control
Participants assigned to use Test Condom A first followed by Test Condom B then Control NRL Condom.
After reporting at least 4 Intravaginal Ejaculation Latency Time (IELT) records (from vaginal entry to ejaculation), participants returned to the clinical site for collection of their next set of condoms. A 3-day washout period, where no test condom was used, was required before participants were supplied with condom type. Participants repeated the assessment period each to test all 3 condom types.
|
A/Control/B
Participants assigned to use Test Condom A first followed by Control NRL Condom then Test Condom B.
After reporting at least 4 IELT records (from vaginal entry to ejaculation), participants returned to the clinical site for collection of their next set of condoms. A 3-day washout period, where no test condom was used, was required before participants were supplied with condom type. Participants repeated the assessment period each to test all 3 condom types.
|
B/A/Control
Participants assigned to use Test Condom B first followed by Test Condom A then Control NRL Condom.
After reporting at least 4 IIELT records (from vaginal entry to ejaculation), participants returned to the clinical site for collection of their next set of condoms. A 3-day washout period, where no test condom was used, was required before participants were supplied with condom type. Participants repeated the assessment period each to test all 3 condom types.
|
B/Control/A
Participants assigned to use Test Condom B first followed by Control NRL Condom then Test Condom A.
After reporting at least 4 IELT records (from vaginal entry to ejaculation), participants returned to the clinical site for collection of their next set of condoms. A 3-day washout period, where no test condom was used, was required before participants were supplied with condom type. Participants repeated the assessment period each to test all 3 condom types.
|
Control/A/B
Participants assigned to use Control NRL Condom first followed by Test Condom A then Test Condom B.
After reporting at least 4 IELT records (from vaginal entry to ejaculation), participants returned to the clinical site for collection of their next set of condoms. A 3-day washout period, where no test condom was used, was required before participants were supplied with condom type. Participants repeated the assessment period each to test all 3 condom types.
|
Control/B/A
Participants assigned to use Control NRL Condom first followed by Test Condom B then Test Condom A.
After reporting at least 4 IELT records (from vaginal entry to ejaculation), participants returned to the clinical site for collection of their next set of condoms. A 3-day washout period, where no test condom was used, was required before participants were supplied with condom type. Participants repeated the assessment period each to test all 3 condom types.
|
|---|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Age was analyzed by male participants and female participants.
Baseline characteristics by cohort
| Measure |
Overall Study
n=300 Participants
150 couples were enrolled to the study and were randomised to 6 arms (A/B/Control, A/Control/B, B/A/Control, B/Control/A, Control/A/B, Control/B/A).
|
|---|---|
|
Age, Customized
Male Participants
|
33.94 years
STANDARD_DEVIATION 10.38 • n=150 Participants • Age was analyzed by male participants and female participants.
|
|
Age, Customized
Female Participants
|
32.11 years
STANDARD_DEVIATION 10.14 • n=150 Participants • Age was analyzed by male participants and female participants.
|
|
Sex: Female, Male
Female
|
150 Participants
n=300 Participants
|
|
Sex: Female, Male
Male
|
150 Participants
n=300 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
138 Participants
n=150 Participants • Ethnicity was collected for 150 male participants only.
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=150 Participants • Ethnicity was collected for 150 male participants only.
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=150 Participants • Ethnicity was collected for 150 male participants only.
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=150 Participants • Ethnicity was collected for 150 male participants only.
|
PRIMARY outcome
Timeframe: 4 weeks for each assessment period (intervention duration)Population: Randomised participants who used at least one of the test condoms and who had reported at least one record of the post-baseline study periods.
Participants recorded the duration from vaginal entry to ejaculation for each condom use. The outcome was evaluated by the change from baseline with the Test Condom A compared to the Control NRL Condom, over a 4-week assessment period. This outcome was to measure the per participant's average IELT time per condom type. The Intravaginal Ejaculation Latency Time (IELT) is the duration from the start of vaginal entry (vaginal penetration into the female partner) until the start of intravaginal ejaculation (release of semen). It did not analyze all condom uses or sexual encounters as a unit, rather those were taken as an average per participant, in order to effectively run a Generalized Linear Mixed Model. This outcome measure data was collected and analyzed for 150 male participants.
Outcome measures
| Measure |
Test Condom A
n=145 Participants
NRL condom with 5% benzocaine paste
|
Control NRL Condom
n=144 Participants
Test control condom - natural rubber latex
|
Control NRL Condom
Test control condom - natural rubber latex
|
Baseline
Baseline
|
|---|---|---|---|---|
|
To Determine the Effectiveness of Benzocaine of the Test Condom A Compared With the Control NRL Condom at Prolonging Time to Ejaculation
|
168.40 Seconds
Standard Error 15.45
|
104.46 Seconds
Standard Error 15.53
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeks for each assessment period (intervention duration)Population: Randomised participants who used at least one of the test condoms and who had reported at least one record of the post-baseline study periods.
Participants recorded the duration from vaginal entry to ejaculation for each condom use. The outcome was evaluated by the change from baseline with the Test Condom B compared to the Control NRL Condom, over a 4-week assessment period. This outcome was to measure the per participant's average IELT time per condom type. It did not analyze all condom uses or sexual encounters as a unit, rather those were taken as an average per participant, in order to effectively run a Generalized Linear Mixed Model. This outcome measure data was collected and analyzed for 150 male participants.
Outcome measures
| Measure |
Test Condom A
n=146 Participants
NRL condom with 5% benzocaine paste
|
Control NRL Condom
n=144 Participants
Test control condom - natural rubber latex
|
Control NRL Condom
Test control condom - natural rubber latex
|
Baseline
Baseline
|
|---|---|---|---|---|
|
To Determine the Effectiveness of Benzocaine of the Test Condom B Compared With the Control NRL Condom at Prolonging Time to Ejaculation
|
124.96 Seconds
Standard Error 15.31
|
104.46 Seconds
Standard Error 15.53
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeks for each assessment period (intervention duration)Population: Randomised participants who used at least one of the test condoms and who had reported at least one record of the post-baseline study periods.
Participants recorded the duration from vaginal entry to ejaculation for each condom use. The outcome was evaluated by the proportion of participants who achieved an increase of 2, 3 and 4 minutes from baseline in each of the Test Condom A and Test Condom B compared to the Control NRL Condom. The odds ratio compares the odds of achieving a given duration increase (e.g., ≥2 minutes) with Test Condom A or B to the odds of achieving the same increase with the Control Condom. An odds ratio greater than 1 suggests the test condom is more effective than the control in helping participants reach that milestone. This outcome measure data was collected and analyzed for 150 male participants.
Outcome measures
| Measure |
Test Condom A
n=145 Participants
NRL condom with 5% benzocaine paste
|
Control NRL Condom
n=146 Participants
Test control condom - natural rubber latex
|
Control NRL Condom
Test control condom - natural rubber latex
|
Baseline
Baseline
|
|---|---|---|---|---|
|
To Determine the Effectiveness of Benzocaine of the Test Condom A and Test Condom B Compared With the Control NRL Condom at Prolonging Time to Ejaculation for an Increase of 2, 3 and 4 Minutes
2 mins
|
1.58 Odd ratios
Interval 0.98 to 2.55
|
1.36 Odd ratios
Interval 0.84 to 2.19
|
—
|
—
|
|
To Determine the Effectiveness of Benzocaine of the Test Condom A and Test Condom B Compared With the Control NRL Condom at Prolonging Time to Ejaculation for an Increase of 2, 3 and 4 Minutes
3 mins
|
1.72 Odd ratios
Interval 1.04 to 2.84
|
1.25 Odd ratios
Interval 0.75 to 2.08
|
—
|
—
|
|
To Determine the Effectiveness of Benzocaine of the Test Condom A and Test Condom B Compared With the Control NRL Condom at Prolonging Time to Ejaculation for an Increase of 2, 3 and 4 Minutes
4 mins
|
1.65 Odd ratios
Interval 0.95 to 2.86
|
1.22 Odd ratios
Interval 0.69 to 2.14
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeks for each assessment period (intervention duration)Population: Randomised participants who used at least one of the test condoms and who had reported at least one record of the post-baseline study periods.
The outcome was assessed by the measure of EMSEX (Event-level Male Sexual) pleasure scale questionnaire, a subject perceived questionnaire, at the end of a 4-week assessment period when using Test Condom A or Test Condom B compared with the Control NRL Condom. EMSEX pleasure scale is a 11-item scale which assesses sexual pleasure at the event level. For each item, the range spans the entirety of the potential range from 0 (zero) to 100 (one hundred). This outcome measure data was collected and analyzed for 150 male participants.
Outcome measures
| Measure |
Test Condom A
n=145 Participants
NRL condom with 5% benzocaine paste
|
Control NRL Condom
n=146 Participants
Test control condom - natural rubber latex
|
Control NRL Condom
n=144 Participants
Test control condom - natural rubber latex
|
Baseline
Baseline
|
|---|---|---|---|---|
|
To Evaluate the Sexual Pleasure When Using the Test Condom A or Test Condom B Compared With the Control NRL Condom
|
69.93 Total EMSEX pleasure score mean value
Interval 67.4 to 72.5
|
69.67 Total EMSEX pleasure score mean value
Interval 67.2 to 72.2
|
68.93 Total EMSEX pleasure score mean value
Interval 66.6 to 71.3
|
—
|
SECONDARY outcome
Timeframe: 4 weeks for each assessment period (intervention duration)Population: Randomised participants who used at least one of the test condoms and who had reported at least one record of the post-baseline study periods.
The outcome was assessed by the measure of Patient Global Impression of Change (PGIC), a subject perceived questionnaire, at the end of a 4-week assessment period when using Test Condom A or Test Condom B compared with the Control NRL Condom. The PGIC is a 7-point response scale (Very much better, Better, Little better, No change, Little worse, Worse, Very much worse). This outcome measure data was collected and analyzed for 150 male participants.
Outcome measures
| Measure |
Test Condom A
n=148 Participants
NRL condom with 5% benzocaine paste
|
Control NRL Condom
n=148 Participants
Test control condom - natural rubber latex
|
Control NRL Condom
n=148 Participants
Test control condom - natural rubber latex
|
Baseline
Baseline
|
|---|---|---|---|---|
|
To Evaluate the Subject's Improvement at "Lasting Longer" for Both the Test Condom A and Test Condom B Compared With the Control NRL Condom
Not Applicable
|
5 participants
|
3 participants
|
4 participants
|
—
|
|
To Evaluate the Subject's Improvement at "Lasting Longer" for Both the Test Condom A and Test Condom B Compared With the Control NRL Condom
Very Much Better
|
12 participants
|
6 participants
|
5 participants
|
—
|
|
To Evaluate the Subject's Improvement at "Lasting Longer" for Both the Test Condom A and Test Condom B Compared With the Control NRL Condom
Better
|
47 participants
|
46 participants
|
38 participants
|
—
|
|
To Evaluate the Subject's Improvement at "Lasting Longer" for Both the Test Condom A and Test Condom B Compared With the Control NRL Condom
Little Better
|
49 participants
|
55 participants
|
46 participants
|
—
|
|
To Evaluate the Subject's Improvement at "Lasting Longer" for Both the Test Condom A and Test Condom B Compared With the Control NRL Condom
No Change
|
32 participants
|
31 participants
|
44 participants
|
—
|
|
To Evaluate the Subject's Improvement at "Lasting Longer" for Both the Test Condom A and Test Condom B Compared With the Control NRL Condom
Little Worse
|
1 participants
|
4 participants
|
5 participants
|
—
|
|
To Evaluate the Subject's Improvement at "Lasting Longer" for Both the Test Condom A and Test Condom B Compared With the Control NRL Condom
Worse
|
1 participants
|
2 participants
|
6 participants
|
—
|
|
To Evaluate the Subject's Improvement at "Lasting Longer" for Both the Test Condom A and Test Condom B Compared With the Control NRL Condom
Very Much Worse
|
1 participants
|
1 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: 4 weeks for each assessment period (intervention duration)Population: Randomised participants who used at least one of the test condoms and who had reported at least one record of the post-baseline study periods.
Upon completion of each condom assessment period, each participant was required to complete a SPQ. The questionnaire collected the following information (including but not limited to): experience with condom use, acceptability, preference and tolerability. This outcome measure data was collected and analyzed for 150 male participants.
Outcome measures
| Measure |
Test Condom A
n=148 Participants
NRL condom with 5% benzocaine paste
|
Control NRL Condom
n=148 Participants
Test control condom - natural rubber latex
|
Control NRL Condom
n=148 Participants
Test control condom - natural rubber latex
|
Baseline
Baseline
|
|---|---|---|---|---|
|
Participant - Subject Perceived Questionnaire (SPQ)
Q1.Somewhat satisfied
|
64 participants
|
70 participants
|
68 participants
|
—
|
|
Participant - Subject Perceived Questionnaire (SPQ)
Q1. Very satisfied
|
19 participants
|
11 participants
|
10 participants
|
—
|
|
Participant - Subject Perceived Questionnaire (SPQ)
Q2. Neither dissatisfied or satisfied
|
28 participants
|
25 participants
|
26 participants
|
—
|
|
Participant - Subject Perceived Questionnaire (SPQ)
Q2. Tolerability gentleness of this condom on the intimate area? Not Applicable
|
4 participants
|
5 participants
|
4 participants
|
—
|
|
Participant - Subject Perceived Questionnaire (SPQ)
Q2. Very dissatisfied
|
5 participants
|
7 participants
|
5 participants
|
—
|
|
Participant - Subject Perceived Questionnaire (SPQ)
Q2. Somewhat dissatisfied
|
29 participants
|
14 participants
|
27 participants
|
—
|
|
Participant - Subject Perceived Questionnaire (SPQ)
Q2. Somewhat satisfied
|
63 participants
|
83 participants
|
63 participants
|
—
|
|
Participant - Subject Perceived Questionnaire (SPQ)
Q2. Very satisfied
|
19 participants
|
14 participants
|
23 participants
|
—
|
|
Participant - Subject Perceived Questionnaire (SPQ)
Q3. Very satisfied
|
50 participants
|
39 participants
|
40 participants
|
—
|
|
Participant - Subject Perceived Questionnaire (SPQ)
Q1. Overall, how satisfied are you with the effectiveness of this condom? Not Applicable
|
4 participants
|
5 participants
|
4 participants
|
—
|
|
Participant - Subject Perceived Questionnaire (SPQ)
Q1. Very dissatisfied
|
6 participants
|
7 participants
|
10 participants
|
—
|
|
Participant - Subject Perceived Questionnaire (SPQ)
Q1. Somewhat dissatisfied
|
18 participants
|
23 participants
|
27 participants
|
—
|
|
Participant - Subject Perceived Questionnaire (SPQ)
Q1. Neither dissatisfied or satisfied
|
37 participants
|
32 participants
|
29 participants
|
—
|
|
Participant - Subject Perceived Questionnaire (SPQ)
Q3.Overall, how satisfied are you with the usability (ease of use) of this condom? Not Applicable
|
5 participants
|
5 participants
|
4 participants
|
—
|
|
Participant - Subject Perceived Questionnaire (SPQ)
Q3. Very dissatisfied
|
8 participants
|
1 participants
|
3 participants
|
—
|
|
Participant - Subject Perceived Questionnaire (SPQ)
Q3. Somewhat dissatisfied
|
8 participants
|
12 participants
|
11 participants
|
—
|
|
Participant - Subject Perceived Questionnaire (SPQ)
Q3. Neither dissatisfied or satisfied
|
15 participants
|
18 participants
|
16 participants
|
—
|
|
Participant - Subject Perceived Questionnaire (SPQ)
Q3. Somewhat satisfied
|
62 participants
|
73 participants
|
74 participants
|
—
|
SECONDARY outcome
Timeframe: 4 weeks for each assessment period (intervention duration)Population: Clinical failure rate was defined if at least one of the following variables were met: * Condom breakage or tearing of the condom during intercourse or withdrawal from the vagina * Condom completely slipped off from the base of the penis during intercourse or * Condom completely slipped off from the base of the penis during withdrawal from the vagina because user did not hold onto the condom at the base of the penis during withdrawal
Number of clinical failure events per usages (clinical slippage or clinical breakage) reported by participants. The number of outcomes are based on the number of sexual encounters while wearing one of the three condoms being tested. This outcome measure data was collected and analyzed for 150 male participants.
Outcome measures
| Measure |
Test Condom A
n=792 Condom Usages
NRL condom with 5% benzocaine paste
|
Control NRL Condom
n=787 Condom Usages
Test control condom - natural rubber latex
|
Control NRL Condom
n=781 Condom Usages
Test control condom - natural rubber latex
|
Baseline
Baseline
|
|---|---|---|---|---|
|
Total Clinical Failure Rate of Each Type of Condoms
|
2.0 Percent of condoms that failed
|
1.4 Percent of condoms that failed
|
0.6 Percent of condoms that failed
|
—
|
SECONDARY outcome
Timeframe: 19 weeksPopulation: All male participants
Overall proportion of participants with Adverse Events/Adverse Device Effects (AE/ADEs) i.e. the occurrence of one of more AE/ADE per participant. The result is presented by the counts of all AEs sorted by SOC and PT for male participants. This outcome measure data was collected and analyzed for 150 male participants.
Outcome measures
| Measure |
Test Condom A
n=150 Participants
NRL condom with 5% benzocaine paste
|
Control NRL Condom
n=150 Participants
Test control condom - natural rubber latex
|
Control NRL Condom
n=150 Participants
Test control condom - natural rubber latex
|
Baseline
n=150 Participants
Baseline
|
|---|---|---|---|---|
|
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Male Participants
Infections and infestations / Covid-19
|
2 Number of AEs
|
1 Number of AEs
|
1 Number of AEs
|
0 Number of AEs
|
|
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Male Participants
Infections and infestations / Nasopharyngitis
|
2 Number of AEs
|
8 Number of AEs
|
6 Number of AEs
|
0 Number of AEs
|
|
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Male Participants
Infections and infestations / Norovirus infection
|
0 Number of AEs
|
0 Number of AEs
|
1 Number of AEs
|
0 Number of AEs
|
|
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Male Participants
Vascular disorders / Hypertension
|
1 Number of AEs
|
0 Number of AEs
|
1 Number of AEs
|
0 Number of AEs
|
|
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Male Participants
Baseline / Infections and infestations / Gastrointestinal infection
|
0 Number of AEs
|
0 Number of AEs
|
0 Number of AEs
|
1 Number of AEs
|
|
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Male Participants
Baseline / Infections and infestations / Nasopharyngitis
|
0 Number of AEs
|
0 Number of AEs
|
0 Number of AEs
|
12 Number of AEs
|
|
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Male Participants
Baseline / Infections and infestations / Tonsillitis
|
0 Number of AEs
|
0 Number of AEs
|
0 Number of AEs
|
1 Number of AEs
|
|
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Male Participants
Baseline / Injury, poisoning and procedural complications / Muscle rupture
|
0 Number of AEs
|
0 Number of AEs
|
0 Number of AEs
|
1 Number of AEs
|
|
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Male Participants
Baseline / Injury, poisoning and procedural complications / Thermal burn
|
0 Number of AEs
|
0 Number of AEs
|
0 Number of AEs
|
1 Number of AEs
|
|
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Male Participants
Gastrointestinal disorders / Gastrointestinal disorder
|
0 Number of AEs
|
0 Number of AEs
|
1 Number of AEs
|
0 Number of AEs
|
|
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Male Participants
Injury, poisoning and procedural complications / Intentional device misuse
|
2 Number of AEs
|
1 Number of AEs
|
1 Number of AEs
|
0 Number of AEs
|
|
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Male Participants
Injury, poisoning and procedural complications / Ligament sprain
|
1 Number of AEs
|
0 Number of AEs
|
0 Number of AEs
|
0 Number of AEs
|
|
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Male Participants
Injury, poisoning and procedural complications / Epicondylitis
|
0 Number of AEs
|
0 Number of AEs
|
1 Number of AEs
|
0 Number of AEs
|
|
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Male Participants
Injury, poisoning and procedural complications / Procedural pain
|
0 Number of AEs
|
0 Number of AEs
|
1 Number of AEs
|
0 Number of AEs
|
|
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Male Participants
Reproductive system and breast disorders / Ejaculation failure
|
1 Number of AEs
|
0 Number of AEs
|
0 Number of AEs
|
0 Number of AEs
|
|
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Male Participants
Reproductive system and breast disorders / Genital hypoaesthesia
|
1 Number of AEs
|
0 Number of AEs
|
0 Number of AEs
|
0 Number of AEs
|
|
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Male Participants
Surgical and medical procedures / Wisdom teeth removal
|
0 Number of AEs
|
0 Number of AEs
|
1 Number of AEs
|
0 Number of AEs
|
SECONDARY outcome
Timeframe: 19 weeksPopulation: All female participants
Overall proportion of participants with Adverse Events/Adverse Device Effects (AE/ADEs) i.e. the occurrence of one of more AE/ADE per participant. The result is presented by the counts of all AEs sorted by SOC and PT for male participants. This outcome measure data was collected and analyzed for 150 female participants.
Outcome measures
| Measure |
Test Condom A
n=150 Participants
NRL condom with 5% benzocaine paste
|
Control NRL Condom
n=150 Participants
Test control condom - natural rubber latex
|
Control NRL Condom
n=150 Participants
Test control condom - natural rubber latex
|
Baseline
n=150 Participants
Baseline
|
|---|---|---|---|---|
|
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Female Participants
Metabolism and nutrition disorders / Vitamin D deficiency
|
0 Number of AEs
|
1 Number of AEs
|
0 Number of AEs
|
0 Number of AEs
|
|
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Female Participants
Baseline / Infections and infestations / COVID-19
|
0 Number of AEs
|
0 Number of AEs
|
0 Number of AEs
|
1 Number of AEs
|
|
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Female Participants
Baseline / Infections and infestations / Nasopharyngitis
|
0 Number of AEs
|
0 Number of AEs
|
0 Number of AEs
|
5 Number of AEs
|
|
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Female Participants
Baseline / Infections and infestations / Tonsillitis
|
0 Number of AEs
|
0 Number of AEs
|
0 Number of AEs
|
1 Number of AEs
|
|
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Female Participants
Infections and infestations / COVID-19
|
2 Number of AEs
|
0 Number of AEs
|
1 Number of AEs
|
0 Number of AEs
|
|
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Female Participants
Reproductive system and breast disorders / Genital hypoaesthesia
|
1 Number of AEs
|
0 Number of AEs
|
0 Number of AEs
|
0 Number of AEs
|
|
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Female Participants
Reproductive system and breast disorders / Vulvovaginal inflammation
|
2 Number of AEs
|
0 Number of AEs
|
0 Number of AEs
|
0 Number of AEs
|
|
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Female Participants
Endocrine disorders / Hypothyroidism
|
0 Number of AEs
|
1 Number of AEs
|
0 Number of AEs
|
0 Number of AEs
|
|
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Female Participants
Infections and infestations / Nasopharyngitis
|
0 Number of AEs
|
2 Number of AEs
|
3 Number of AEs
|
0 Number of AEs
|
|
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Female Participants
Infections and infestations / Pharyngitis
|
0 Number of AEs
|
1 Number of AEs
|
0 Number of AEs
|
0 Number of AEs
|
|
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Female Participants
Reproductive system and breast disorders / Vulvovaginal dryness
|
0 Number of AEs
|
1 Number of AEs
|
0 Number of AEs
|
0 Number of AEs
|
|
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Female Participants
Gastrointestinal disorders Gastrointestinal disorder / Gastrointestinal disorder
|
0 Number of AEs
|
0 Number of AEs
|
1 Number of AEs
|
0 Number of AEs
|
|
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Female Participants
Reproductive system and breast disorders / Vulvovaginal pain
|
0 Number of AEs
|
0 Number of AEs
|
1 Number of AEs
|
0 Number of AEs
|
|
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Female Participants
Respiratory, thoracic and mediastinal disorders / Sinus congestion
|
0 Number of AEs
|
0 Number of AEs
|
1 Number of AEs
|
0 Number of AEs
|
|
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Female Participants
Skin and subcutaneous tissue disorders / Dermatitis atopic
|
0 Number of AEs
|
0 Number of AEs
|
1 Number of AEs
|
0 Number of AEs
|
Adverse Events
Test Condom A - Males
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Test Condom B - Males
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Control NRL Condom - Males
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Baseline - Males
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Test Condom A - Females
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Test Condom B - Females
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control NRL Condom - Females
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Baseline - Females
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Condom A - Males
n=150 participants at risk
NRL condom with 5% benzocaine paste
|
Test Condom B - Males
n=150 participants at risk
NRL condom with 3% benzocaine paste
|
Control NRL Condom - Males
n=150 participants at risk
Test control condom - natural rubber latex
|
Baseline - Males
n=150 participants at risk
Baseline
|
Test Condom A - Females
n=150 participants at risk
NRL condom with 5% benzocaine paste
|
Test Condom B - Females
n=150 participants at risk
NRL condom with 3% benzocaine paste
|
Control NRL Condom - Females
n=150 participants at risk
Test control condom - natural rubber latex
|
Baseline - Females
n=150 participants at risk
Baseline
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/150 • 19 weeks
An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.
|
5.3%
8/150 • Number of events 8 • 19 weeks
An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.
|
0.00%
0/150 • 19 weeks
An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.
|
7.3%
11/150 • Number of events 12 • 19 weeks
An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.
|
0.00%
0/150 • 19 weeks
An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.
|
0.00%
0/150 • 19 weeks
An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.
|
0.00%
0/150 • 19 weeks
An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.
|
0.00%
0/150 • 19 weeks
An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.
|
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 Publication of the results of the Study, whether in whole or in part, shall be within the sole and absolute discretion of the sponsor, and CRO/PI shall not be entitled to publish any of the data or information arising during the Study without the prior written consent of the sponsor.
- Publication restrictions are in place
Restriction type: OTHER