Ejaculation Delayed
Conditions
Brief 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.
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.
Interventions
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.
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.
DEVICEControl NRL condom
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.
Sponsors
Reckitt Benckiser Healthcare (UK) Limited
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Main Inclusion Criteria: 1. Subjects and their female partners have provided written informed consent. 2. Subjects and their female partners between the ages of \>= 18 years and =\< 60 years. 3. Subjects and their female partners must have no health condition in their medical history. 4. Subject must be sexually active having regular intercourse. 5. Subjects in a stable, monogamous, sexual relationship with the same female partner for more than or equal to 3 months. 6. Subject's female partner should already be on an established other highly effective form of non-barrier contraception, unless post-menopausal. 7. Subjects reporting a frequency of 'occasionally' to the Sexual Intercourse Self-Estimation Scale. Main
Exclusion criteria
1. Subject with a pregnant or breastfeeding female partner or the female partner desires to become pregnant during the clinical investigation. 2. Subject or his female partner with a current history of alcohol or drug abuse. 3. 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. 4. 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. 5. 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: 1. urological disease, 2. ongoing significant psychiatric disorder not controlled by medication 3. history of surgery or injury to the pelvis, retroperitoneal surgery, radiotherapy, multiple sclerosis, spinal cord injury, chronic inflammation of the prostate or urethra 4. relevant previous or planned genital surgery 5. female partner that has been diagnosed with or treated for vaginal complaints (including vaginal dryness) 6. any broken skin or wounds in the genital area. 6. Subjects on medication that is contraindicated, which may affect erection. 7. 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. 8. Subject and/or his female partner is using or intends to continue to use antibiotics of the sulphonamide type. 9. 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. 10. Subject that has been diagnosed or received treatment for PE (premature ejaculation). 11. Subjects with confirmed erectile dysfunction, hypo or hyperthyroidism, hypogonadism, hyperprolactinemia. 12. Confirmed diagnosis of male subjects with other forms of ejaculatory dysfunction. 13. Subjects that have had prior genital, prostatic or lower tract surgery. 14. Subjects with haemorrhagic disorder, hepatitis B or C, HIV infection or having had penile implant surgery, at any time in their past. 15. Either partner needed to use condoms for a specific STI protection. 16. Subjects and their female partners who have any relevant history of allergy including local anaesthetics, parabens, PABA, commercial hair dyes, paraphenylenediamine, lubricants and latex.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Determine the Effectiveness of Benzocaine of the Test Condom A Compared With the Control NRL Condom at Prolonging Time to Ejaculation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Determine the Effectiveness of Benzocaine of the Test Condom B Compared With the Control NRL Condom at Prolonging Time to Ejaculation | 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 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. |
| 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 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 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. |
| To Evaluate the Sexual Pleasure When Using the Test Condom A or Test Condom B Compared With the Control NRL Condom | 4 weeks for each assessment period (intervention duration) | 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. |
| 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 | 4 weeks for each assessment period (intervention duration) | 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. |
| Participant - Subject Perceived Questionnaire (SPQ) | 4 weeks for each assessment period (intervention duration) | 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. |
| Total Clinical Failure Rate of Each Type of Condoms | 4 weeks for each assessment period (intervention duration) | 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. |
| Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Male Participants | 19 weeks | 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. |
| Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Female Participants | 19 weeks | 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. |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORKirstin Deuble-Bente, MD
SGS proderm GmbH
Participant flow
Recruitment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Female Participants | 32.11 years STANDARD_DEVIATION 10.14 |
| Age, Customized Male Participants | 33.94 years STANDARD_DEVIATION 10.38 |
| Race/Ethnicity, Customized Asian | 7 Participants |
| Race/Ethnicity, Customized Black | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 138 Participants |
| Race/Ethnicity, Customized Other | 4 Participants |
| Sex: Female, Male Female | 150 Participants |
| Sex: Female, Male Male | 150 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 150 | 0 / 150 | 0 / 150 | 0 / 150 | 0 / 150 | 0 / 150 | 0 / 150 | 0 / 150 |
| other Total, other adverse events | 0 / 150 | 8 / 150 | 0 / 150 | 11 / 150 | 0 / 150 | 0 / 150 | 0 / 150 | 0 / 150 |
| serious Total, serious adverse events | 0 / 150 | 0 / 150 | 0 / 150 | 0 / 150 | 0 / 150 | 0 / 150 | 0 / 150 | 0 / 150 |
Outcome results
None listed