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The investigation is to evaluate the effectiveness of benzocaine in two NRL condoms compared with a standard NRL control without benzocaine in prolonging time to ejaculation in healthy adult men who feel they ejaculate too quickly during vaginal sex.
In this investigation, two NRL condoms with benzocaine paste (Test condom A and Test condom B) will be evaluated against a standard NRL male condom (Control condom) in prolonging time to ejaculation in healthy adult men who feel they ejaculate too quickly during vaginal sex.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test condom A (NRL condom with 5% benzocaine paste) | Experimental | Following randomization, each subject will be given one set of 8 condoms as per randomisation schedule. After reporting at least 4 duration records (from vaginal entry to ejaculation), subjects will return to the clinical site for collection of their next set of condoms. |
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| Test condom B (NRL condom with 3% benzocaine paste) | Experimental | Following randomization, each subject will be given one set of 8 condoms as per randomisation schedule. After reporting at least 4 duration records (from vaginal entry to ejaculation), subjects will return to the clinical site for collection of their next set of condoms. |
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| Control NRL condom | Placebo Comparator | Following randomization, each subject will be given one set of 8 condoms as per randomisation schedule. After reporting at least 4 duration records (from vaginal entry to ejaculation), subjects will return to the clinical site for collection of their next set of condoms. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test condom A (NRL condom with 5% benzocaine paste) | Device | In each assessment period, subjects will be provided with a condom type to use during vaginal intercourse and will report at least 4 duration records (from vaginal entry to ejaculation) over a 4-week period. Subjects will repeat the assessment period each to test all 3 condom types. |
| Measure | Description | Time Frame |
|---|---|---|
| To Determine the Effectiveness of Benzocaine of the Test Condom A Compared With the Control NRL Condom at Prolonging Time to Ejaculation | 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. | 4 weeks for each assessment period (intervention duration) |
| Measure | Description | Time Frame |
|---|---|---|
| To Determine the Effectiveness of Benzocaine of the Test Condom B Compared With the Control NRL Condom at Prolonging Time to Ejaculation | 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. |
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Main Inclusion Criteria:
Main Exclusion Criteria:
Subject with a pregnant or breastfeeding female partner or the female partner desires to become pregnant during the clinical investigation.
Subject or his female partner with a current history of alcohol or drug abuse.
Subjects and their female partners with a history of or are suffering from anemia, coronary artery disease, impaired cardiac conduction, pulmonary disease, diabetes, and renal or hepatic disease.
Subjects and their female partners with a history of, suspected to have, or be at increased risk of methaemoglobinemia / complications related to ester anaesthetics which could trigger methemoglobinemia.
Subject and/or his female partner have a physical or psychological condition that would prevent them from following investigation procedures - including but not limited to the following:
Subjects on medication that is contraindicated, which may affect erection.
Subject and/or his female partner have any medication which may affect the safety of the subject, including but not limited to benzocaine drug interactions such as cholinesterase inhibitors.
Subject and/or his female partner is using or intends to continue to use antibiotics of the sulphonamide type.
Subject with premature ejaculation, erectile dysfunction, hypo or hyperthyroidism, hypogonadism, hyperprolactinemia, ejaculatory dysfunction, haemorrhagic disorder, hepatitis B or C, human immunodeficiency virus (HIV) infection or having had penile implant surgery.
Subject that has been diagnosed or received treatment for PE (premature ejaculation).
Subjects with confirmed erectile dysfunction, hypo or hyperthyroidism, hypogonadism, hyperprolactinemia.
Confirmed diagnosis of male subjects with other forms of ejaculatory dysfunction.
Subjects that have had prior genital, prostatic or lower tract surgery.
Subjects with haemorrhagic disorder, hepatitis B or C, HIV infection or having had penile implant surgery, at any time in their past.
Either partner needed to use condoms for a specific STI protection.
Subjects and their female partners who have any relevant history of allergy including local anaesthetics, parabens, PABA, commercial hair dyes, paraphenylenediamine, lubricants and latex.
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| Name | Affiliation | Role |
|---|---|---|
| Kirstin Deuble-Bente, MD | SGS proderm GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS proderm GmbH | Hamburg | Germany |
IPD will be shared as per local regulations.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 8, 2023 | Oct 6, 2025 |
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The condom types will be tested in a 3-way cross-over design where subjects will be randomised to use each of the 3 condom types in a defined order, according to the randomisation schedule.
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| Test condom B (NRL condom with 3% benzocaine paste) | Device | In each assessment period, subjects will be provided with a condom type to use during vaginal intercourse and will report at least 4 duration records (from vaginal entry to ejaculation) over a 4-week period. Subjects will repeat the assessment period each to test all 3 condom types. |
|
| Control NRL condom | Device | In each assessment period, subjects will be provided with a condom type to use during vaginal intercourse and will report at least 4 duration records (from vaginal entry to ejaculation) over a 4-week period. Subjects will repeat the assessment period each to test all 3 condom types. |
|
| 4 weeks for each assessment period (intervention duration) |
| 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 | 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. | 4 weeks for each assessment period (intervention duration) |
| To Evaluate the Sexual Pleasure When Using the Test Condom A or Test Condom B Compared With the Control NRL Condom | 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. | 4 weeks for each assessment period (intervention duration) |
| 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 | 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. | 4 weeks for each assessment period (intervention duration) |
| Participant - Subject Perceived Questionnaire (SPQ) | 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. | 4 weeks for each assessment period (intervention duration) |
| Total Clinical Failure Rate of Each Type of Condoms | 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. | 4 weeks for each assessment period (intervention duration) |
| Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - 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. | 19 weeks |
| Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - 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. | 19 weeks |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| Male Participants |
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| Female Participants |
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| COMPLETED |
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| NOT COMPLETED |
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150 couples were enrolled. Age and safety were collected for both male and female participants. Other endpoints were analyzed for male participants' data only.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | 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). |
| Units | Counts |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age was analyzed by male participants and female participants. | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Ethnicity was collected for 150 male participants only. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | To Determine the Effectiveness of Benzocaine of the Test Condom A Compared With the Control NRL Condom at Prolonging Time to Ejaculation | 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. | 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. | Posted | Least Squares Mean | Standard Error | Seconds | 4 weeks for each assessment period (intervention duration) |
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| Secondary | To Determine the Effectiveness of Benzocaine of the Test Condom B Compared With the Control NRL Condom at Prolonging Time to Ejaculation | 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. | 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. | Posted | Least Squares Mean | Standard Error | Seconds | 4 weeks for each assessment period (intervention duration) |
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| Secondary | 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 | 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. | 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. | Posted | Number | 95% Confidence Interval | Odd ratios | 4 weeks for each assessment period (intervention duration) |
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| Secondary | To Evaluate the Sexual Pleasure When Using the Test Condom A or Test Condom B Compared With the Control NRL Condom | 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. | 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. | Posted | Mean | 95% Confidence Interval | Total EMSEX pleasure score mean value | 4 weeks for each assessment period (intervention duration) |
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| Secondary | 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 | 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. | 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. | Posted | Number | participants | 4 weeks for each assessment period (intervention duration) |
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| Secondary | Participant - Subject Perceived Questionnaire (SPQ) | 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. | 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. | Posted | Number | participants | 4 weeks for each assessment period (intervention duration) |
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| Secondary | Total Clinical Failure Rate of Each Type of Condoms | 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. | Clinical failure rate was defined if at least one of the following variables were met:
| Posted | Number | Percent of condoms that failed | 4 weeks for each assessment period (intervention duration) | Condom Usages | Condom Usages |
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| Secondary | Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - 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. | All male participants | Posted | Number | Number of AEs | 19 weeks |
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| Secondary | Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - 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. | All female participants | Posted | Number | Number of AEs | 19 weeks |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test Condom A - Males | NRL condom with 5% benzocaine paste | 0 | 150 | 0 | 150 | 0 | 150 |
| EG001 | Test Condom B - Males | NRL condom with 3% benzocaine paste | 0 | 150 | 0 | 150 | 8 | 150 |
| EG002 | Control NRL Condom - Males | Test control condom - natural rubber latex | 0 | 150 | 0 | 150 | 0 | 150 |
| EG003 | Baseline - Males | Baseline | 0 | 150 | 0 | 150 | 11 | 150 |
| EG004 | Test Condom A - Females | NRL condom with 5% benzocaine paste | 0 | 150 | 0 | 150 | 0 | 150 |
| EG005 | Test Condom B - Females | NRL condom with 3% benzocaine paste | 0 | 150 | 0 | 150 | 0 | 150 |
| EG006 | Control NRL Condom - Females | Test control condom - natural rubber latex | 0 | 150 | 0 | 150 | 0 | 150 |
| EG007 | Baseline - Females | Baseline | 0 | 150 | 0 | 150 | 0 | 150 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 27.1 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Study Manager | Reckitt Benckiser Health Limited | +44 (0)1482 326151 | ClinicalRequests@reckitt.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 24, 2024 | Oct 6, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000097910 | Ejaculatory Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
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