Ejaculation DelayedNCT05255770
A Clinical Investigation to Assess the Effectiveness of Benzocaine Condoms in Healthy Adult Men
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.
Trial summary
This investigation is designed to evaluate the effectiveness of two NRL condoms with Benzocaine paste compared with a standard NRL control. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy 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?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2022to Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 (a minimum frequency of once a week).
- 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.
Who cannot join
- Subject or his female partner with alcohol or drug abuse.
- Subjects and their female partners with anemia, coronary artery disease, impaired cardiac conduction, pulmonary disease, diabetes, and renal or hepatic disease.
- Subjects and their female partners with a risk of methaemoglobinemia / complications related to ester anaesthetics which could trigger methemoglobinemia.
- Subject and/or his female partner with urological disease or genitourinary surgery; 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 genital surgery; a female partner with vaginal complaints; 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 Sulphonamides and cholinesterase inhibitors.
- 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.
- Subjects and their female partners who have any relevant history of allergy including local anaesthetics, parabens, PABA, commercial hair dyes, paraphenylenediamine, lubricants and latex.
About this study
Official title: A Double Masked, Randomised, 3-way Cross-over, Single-center, Clinical Investigation to Evaluate the Effectiveness of Two NRL Condoms With Benzocaine Paste Compared With a Standard NRL Control in Prolonging Time to Ejaculation in Healthy Adult Men
This investigation is designed to evaluate the effectiveness of two NRL condoms with Benzocaine paste compared with a standard NRL control.
Read the detailed description
In this clinical 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.
- 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 (intervention duration), 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.
Test condom B (NRL condom with 3% benzocaine paste)Device
In each assessment period (intervention duration), 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.
Control NRL condomDevice
In each assessment period (intervention duration), 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.
| Study group | Role | What they receive |
|---|---|---|
| Test condom A (NRL condom with 5% benzocaine paste) | Experimental | Following randomisation 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); Device: Test condom B (NRL condom with 3% benzocaine paste); Device: Control NRL condom |
| Test condom B (NRL condom with 3% benzocaine paste) | Experimental | Following randomisation 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); Device: Test condom B (NRL condom with 3% benzocaine paste); Device: Control NRL condom |
| Control NRL condom | Active comparator | Following randomisation 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); Device: Test condom B (NRL condom with 3% benzocaine paste); 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 the Test Condom A compared with the Control NRL Condom at prolonging time to ejaculation.
Subjects will be recording the duration (time in minutes:seconds) from vaginal entry to ejaculation for each condom use. The outcome is evaluated by the change from baseline with the Test Condom A compared to the Control NRL Condom, over a 4-week assessment period.
Measured: 4 weeks for each assessment period (intervention duration)
Secondary outcomes (5)
To determine the effectiveness of the Test Condom B compared with the Control NRL Condom at prolonging time to ejaculation.
Subjects will be recording the duration (time in minutes:seconds) from vaginal entry to ejaculation for each condom use. The outcome is evaluated by the change from baseline with the Test Condom B compared to the Control NRL Condom, over a 4-week assessment period.
Measured: 4 weeks for each assessment period (intervention duration)
To determine the effectiveness 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.
Subjects will be recording the duration (time in minutes:seconds) from vaginal entry to ejaculation for each condom use. The outcome is evaluated by the proportion of subjects who achieve 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.
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 is 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.
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 is 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.
Measured: 4 weeks for each assessment period (intervention duration)
Subject's experience on the use of each type of condoms [Acceptability and In-Use Tolerability]
Acceptability and in-use tolerability as assessed by subject perceived questionnaires.
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 posted25 Feb 2022
- Study startApr 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Why it stopped: Change of the product development strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255770
- Sponsor's protocol ID
- 5061901
- Status last verified
- Sep 2022
- First submitted
- 23 Dec 2021
- Last updated
- 16 Sep 2022
- Results posted
- No
- 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 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Masked, Randomised, 3-way Cross-over, Single-center, Clinical Investigation to Evaluate the Effectiveness of Two NRL Condoms With Benzocaine Paste Compared With a Standard NRL Control in Prolonging Time to Ejaculation in Healthy Adult Men
- ClinicalTrials.gov ID
- NCT05255770
- Acronym / sponsor ID
- 5061901
- Conditions
- Ejaculation Delayed
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change of the product development strategy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) LimitedIndustry (pharma, biotech, devices)
- Study start
- Apr 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 25 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This investigation is designed to evaluate the effectiveness of two NRL condoms with Benzocaine paste compared with a standard NRL control.
Detailed description
In this clinical 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- 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), Device: Test condom B (NRL condom with 3% benzocaine paste), Device: Control NRL condomFollowing randomisation 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 A (NRL condom with 5% benzocaine paste), Device: Test condom B (NRL condom with 3% benzocaine paste), Device: Control NRL condomFollowing randomisation 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 | Active comparator | Device: Test condom A (NRL condom with 5% benzocaine paste), Device: Test condom B (NRL condom with 3% benzocaine paste), Device: Control NRL condomFollowing randomisation 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
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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 (a minimum frequency of once a week).
- 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.
Key exclusion criteria (8 listed)
- Subject or his female partner with alcohol or drug abuse.
- Subjects and their female partners with anemia, coronary artery disease, impaired cardiac conduction, pulmonary disease, diabetes, and renal or hepatic disease.
- Subjects and their female partners with a risk of methaemoglobinemia / complications related to ester anaesthetics which could trigger methemoglobinemia.
- Subject and/or his female partner with urological disease or genitourinary surgery; 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 genital surgery; a female partner with vaginal complaints; any broken skin or wounds in the genital area.
- Subjects on medication that is contraindicated, which may affect erection.
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 (intervention duration), 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. | Device | Control NRL condom, Test condom A (NRL condom with 5% benzocaine paste), Test condom B (NRL condom with 3% benzocaine paste) |
| Test condom B (NRL condom with 3% benzocaine paste)In each assessment period (intervention duration), 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. | Device | Control NRL condom, Test condom A (NRL condom with 5% benzocaine paste), Test condom B (NRL condom with 3% benzocaine paste) |
| Control NRL condomIn each assessment period (intervention duration), 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. | Device | Control NRL condom, Test condom A (NRL condom with 5% benzocaine paste), Test condom B (NRL condom with 3% benzocaine paste) |
Primary outcome
To determine the effectiveness 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)
Subjects will be recording the duration (time in minutes:seconds) from vaginal entry to ejaculation for each condom use. The outcome is evaluated by the change from baseline with the Test Condom A compared to the Control NRL Condom, over a 4-week assessment period.
5 secondary outcomes
To determine the effectiveness 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 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)
Subject's experience on the use of each type of condoms [Acceptability and In-Use Tolerability]
Time frame: 19 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
- Individual participant dataSharing planned: No. IPD will be shared as per local regulations.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 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 16 Sep 2022.