Ejaculation DelayedNRLNCT05840172
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
A study testing Test condom A (NRL condom with 5% benzocaine paste) and Test condom B (NRL condom with 3% benzocaine paste) in people with Ejaculation Delayed, run by Reckitt Benckiser Healthcare (UK) Limited at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Ejaculation Delayed
- What is being tested?
- Test condom A (NRL condom with 5% benzocaine paste) and Test condom B (NRL condom with 3% benzocaine paste)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- 19 Oct 2023to 7 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Main Inclusion Criteria:
- Subjects and their female partners have provided written informed consent.
- Subjects and their female partners between the ages of >= 18 years and =< 60 years.
- Subjects and their female partners must have no health condition in their medical history.
- Subject must be sexually active having regular intercourse.
- Subjects in a stable, monogamous, sexual relationship with the same female partner for more than or equal to 3 months.
- Subject's female partner should already be on an established other highly effective form of non-barrier contraception, unless post-menopausal.
- Subjects reporting a frequency of 'occasionally' to the Sexual Intercourse Self-Estimation Scale.
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:
- urological disease,
- ongoing significant psychiatric disorder not controlled by medication
- history of surgery or injury to the pelvis, retroperitoneal surgery, radiotherapy, multiple sclerosis, spinal cord injury, chronic inflammation of the prostate or urethra
- relevant previous or planned genital surgery
- female partner that has been diagnosed with or treated for vaginal complaints (including vaginal dryness)
- any broken skin or wounds in the genital area.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Randomised, 3-way Cross-over, Single-centre, Clinical Investigation 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
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.
Read the detailed description
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.
- Conditions
- Ejaculation Delayed
- Being tested
- Test condom A (NRL condom with 5% benzocaine paste), Test condom B (NRL condom with 3% benzocaine paste), Control NRL condom
- Medical subject headings
- Ejaculatory Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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 condomDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Test condom A (NRL condom with 5% benzocaine paste) |
| 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. Receives: Device: Test condom B (NRL condom with 3% benzocaine paste) |
| 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. Receives: Device: Control NRL condom |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks for each assessment period (intervention duration)
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 19 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start19 Oct 2023
- Primary completion7 Oct 2024
- Study completion7 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ejaculation DelayedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kirstin Deuble-Bente, MD, Principal investigator, SGS Proderm GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05840172
- Sponsor's protocol ID
- 5078401
- Acronym
- NRL
- Status last verified
- May 2026
- First submitted
- 21 Apr 2023
- Last updated
- 7 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be shared as per local regulations.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomised, 3-way Cross-over, Single-centre, Clinical Investigation 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
- ClinicalTrials.gov ID
- NCT05840172
- Acronym / sponsor ID
- NRL / 5078401
- Conditions
- Ejaculation Delayed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) LimitedIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 7 Oct 2024 (actual)
- Study completion
- 7 Oct 2024 (actual)
- First posted
- 3 May 2023 (actual)
- Results
- Posted 7 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Test condom A (NRL condom with 5% benzocaine paste) | Experimental | Device: Test condom A (NRL condom with 5% benzocaine paste)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. |
| Test condom B (NRL condom with 3% benzocaine paste) | Experimental | Device: Test condom B (NRL condom with 3% benzocaine paste)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. |
| Control NRL condom | Placebo comparator | Device: Control NRL condomFollowing 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test condom A (NRL condom with 5% benzocaine paste)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. | Device | Test condom A (NRL condom with 5% benzocaine paste) |
| Test condom B (NRL condom with 3% benzocaine paste)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. | Device | Test condom B (NRL condom with 3% benzocaine paste) |
| Control NRL condomIn 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. | Device | Control NRL condom |
Primary outcome
To Determine the Effectiveness of Benzocaine of the Test Condom A Compared With the Control NRL Condom at Prolonging Time to Ejaculation
Time frame: 4 weeks for each assessment period (intervention duration)
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.
8 secondary outcomes
To Determine the Effectiveness of Benzocaine of the Test Condom B Compared With the Control NRL Condom at Prolonging Time to Ejaculation
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 4 weeks for each assessment period (intervention duration)
Participant - Subject Perceived Questionnaire (SPQ)
Time frame: 4 weeks for each assessment period (intervention duration)
Total Clinical Failure Rate of Each Type of Condoms
Time frame: 4 weeks for each assessment period (intervention duration)
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Male Participants
Time frame: 19 weeks
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Female Participants
Time frame: 19 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. IPD will be shared as per local regulations.
Related trials for Ejaculation Delayed
RecruitingObservational study
Ejaculatory and Orgasmic Dysfunction Registry
Ejaculatory Dysfunction, Premature Ejaculation
Recruiting
Prostate Stimulation for Sexual Dysfunction
Sexual Dysfunction, Erectile Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirstin Deuble-Bente, MD principal investigator
SGS Proderm GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test condom A (NRL condom with 5% benzocaine paste) and Test condom B (NRL condom with 3% benzocaine paste) in people with Ejaculation Delayed, run by Reckitt Benckiser Healthcare (UK) Limited at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Determine the Effectiveness of Benzocaine of the Test Condom A Compared With the Control NRL Condom at Prolonging Time to Ejaculation (time frame: 4 weeks for each assessment period (intervention duration)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.