ClinicalTrials.gg
CompletedNCT05840172NRLUpdated May 7, 2026Results posted

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

An interventional study of Test condom A (NRL condom with 5% benzocaine paste) and Test condom B (NRL condom with 3% benzocaine paste) in Ejaculation Delayed, sponsored by Reckitt Benckiser Healthcare (UK) Limited. Completed at 1 site in Germany. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-07.

Sponsored by Reckitt Benckiser Healthcare (UK) Limited (part of Reckitt) · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Ejaculation Delayed
03

In context

Lead sponsor

Reckitt Benckiser Healthcare (UK) Limited is the lead sponsor of 35 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Main Inclusion Criteria:

  1. Subjects and their female partners have provided written .
  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 , unless .
  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 , 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, or C, (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.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
300 participants (actual)

Study arms

  • Experimental
    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.

    Device: Test condom A (NRL condom with 5% benzocaine paste)

  • Experimental
    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.

    Device: Test condom B (NRL condom with 3% benzocaine paste)

  • Placebo comparator
    Control NRL condom

    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.

    Device: Control NRL condom

Interventions

  • DeviceTest 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.

  • DeviceTest 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.

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4 weeks for each assessment period (intervention duration)

Secondary outcomes

  1. 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.

    Time frame: 4 weeks for each assessment period (intervention duration)

  2. 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.

    Time frame: 4 weeks for each assessment period (intervention duration)

  3. 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.

    Time frame: 4 weeks for each assessment period (intervention duration)

  4. 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.

    Time frame: 4 weeks for each assessment period (intervention duration)

  5. 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.

    Time frame: 4 weeks for each assessment period (intervention duration)

  6. 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.

    Time frame: 4 weeks for each assessment period (intervention duration)

  7. 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.

    Time frame: 19 weeks

  8. 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.

    Time frame: 19 weeks

07

Results

Posted May 7, 2026

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 flow — Overall Study
MilestoneA/B/ControlA/Control/BB/A/ControlB/Control/AControl/A/BControl/B/A
Started252525252525
Male participants252525252525
Female participants252525252525
Completed242225232524
Not completed130201
Withdrew: Physician decision110000
Withdrew: Withdrawal by subject020100
Withdrew: Adverse event000100
Withdrew: Lost to follow-up000001

Outcome measures

PrimaryTo 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.

Time frame:
4 weeks for each assessment period (intervention duration)
Reported as:
Least squares mean · Seconds
To Determine the Effectiveness of Benzocaine of the Test Condom A Compared With the Control NRL Condom at Prolonging Time to Ejaculation
SecondsTest Condom AControl NRL Condom
To Determine the Effectiveness of Benzocaine of the Test Condom A Compared With the Control NRL Condom at Prolonging Time to Ejaculation168.40 ± 15.45104.46 ± 15.53
SecondaryTo 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.

Time frame:
4 weeks for each assessment period (intervention duration)
Reported as:
Least squares mean · Seconds
To Determine the Effectiveness of Benzocaine of the Test Condom B Compared With the Control NRL Condom at Prolonging Time to Ejaculation
SecondsTest Condom BControl NRL Condom
To Determine the Effectiveness of Benzocaine of the Test Condom B Compared With the Control NRL Condom at Prolonging Time to Ejaculation124.96 ± 15.31104.46 ± 15.53
SecondaryTo 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.

Time frame:
4 weeks for each assessment period (intervention duration)
Reported as:
Number · Odd ratios
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
Odd ratiosTest Condom ATest Condom B
2 mins1.58 (0.98 to 2.55)1.36 (0.84 to 2.19)
3 mins1.72 (1.04 to 2.84)1.25 (0.75 to 2.08)
4 mins1.65 (0.95 to 2.86)1.22 (0.69 to 2.14)
SecondaryTo 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.

Time frame:
4 weeks for each assessment period (intervention duration)
Reported as:
Mean · Total EMSEX pleasure score mean value
To Evaluate the Sexual Pleasure When Using the Test Condom A or Test Condom B Compared With the Control NRL Condom
Total EMSEX pleasure score mean valueTest Condom ATest Condom BControl NRL Condom
To Evaluate the Sexual Pleasure When Using the Test Condom A or Test Condom B Compared With the Control NRL Condom69.93 (67.40 to 72.50)69.67 (67.20 to 72.20)68.93 (66.60 to 71.30)
SecondaryTo 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.

Time frame:
4 weeks for each assessment period (intervention duration)
Reported as:
Number · 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
participantsTest Condom ATest Condom BControl NRL Condom
Not Applicable534
Very Much Better1265
Better474638
Little Better495546
No Change323144
Little Worse145
Worse126
Very Much Worse110
SecondaryParticipant - 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.

Time frame:
4 weeks for each assessment period (intervention duration)
Reported as:
Number · participants
Participant - Subject Perceived Questionnaire (SPQ)
participantsTest Condom ATest Condom BControl NRL Condom
Q1. Overall, how satisfied are you with the effectiveness of this condom? Not Applicable454
Q1. Very dissatisfied6710
Q1. Somewhat dissatisfied182327
Q1. Neither dissatisfied or satisfied373229
Q1.Somewhat satisfied647068
Q1. Very satisfied191110
Q2. Tolerability gentleness of this condom on the intimate area? Not Applicable454
Q2. Very dissatisfied575
Q2. Somewhat dissatisfied291427
Q2. Neither dissatisfied or satisfied282526
Q2. Somewhat satisfied638363
Q2. Very satisfied191423
Q3.Overall, how satisfied are you with the usability (ease of use) of this condom? Not Applicable554
Q3. Very dissatisfied813
Q3. Somewhat dissatisfied81211
Q3. Neither dissatisfied or satisfied151816
Q3. Somewhat satisfied627374
Q3. Very satisfied503940
SecondaryTotal 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.

Time frame:
4 weeks for each assessment period (intervention duration)
Reported as:
Number · Percent of condoms that failed
Total Clinical Failure Rate of Each Type of Condoms
Percent of condoms that failedTest Condom ATest Condom BControl NRL Condom
Total Clinical Failure Rate of Each Type of Condoms2.01.40.6
SecondaryOverall 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.

Time frame:
19 weeks
Reported as:
Number · Number of AEs
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Male Participants
Number of AEsTest Condom ATest Condom BControl NRL CondomBaseline
Baseline / Infections and infestations / Gastrointestinal infection0001
Baseline / Infections and infestations / Nasopharyngitis00012
Baseline / Infections and infestations / Tonsillitis0001
Baseline / Injury, poisoning and procedural complications / Muscle rupture0001
Baseline / Injury, poisoning and procedural complications / Thermal burn0001
Gastrointestinal disorders / Gastrointestinal disorder0010
Infections and infestations / Covid-192110
Infections and infestations / Nasopharyngitis2860
Infections and infestations / Norovirus infection0010
Injury, poisoning and procedural complications / Intentional device misuse2110
Injury, poisoning and procedural complications / Ligament sprain1000
Injury, poisoning and procedural complications / Epicondylitis0010
Injury, poisoning and procedural complications / Procedural pain0010
Reproductive system and breast disorders / Ejaculation failure1000
Reproductive system and breast disorders / Genital hypoaesthesia1000
Vascular disorders / Hypertension1010
Surgical and medical procedures / Wisdom teeth removal0010
SecondaryOverall 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.

Time frame:
19 weeks
Reported as:
Number · Number of AEs
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Female Participants
Number of AEsTest Condom ATest Condom BControl NRL CondomBaseline
Baseline / Infections and infestations / COVID-190001
Baseline / Infections and infestations / Nasopharyngitis0005
Baseline / Infections and infestations / Tonsillitis0001
Infections and infestations / COVID-192010
Reproductive system and breast disorders / Genital hypoaesthesia1000
Reproductive system and breast disorders / Vulvovaginal inflammation2000
Endocrine disorders / Hypothyroidism0100
Infections and infestations / Nasopharyngitis0230
Infections and infestations / Pharyngitis0100
Metabolism and nutrition disorders / Vitamin D deficiency0100
Reproductive system and breast disorders / Vulvovaginal dryness0100
Gastrointestinal disorders Gastrointestinal disorder / Gastrointestinal disorder0010
Reproductive system and breast disorders / Vulvovaginal pain0010
Respiratory, thoracic and mediastinal disorders / Sinus congestion0010
Skin and subcutaneous tissue disorders / Dermatitis atopic0010

Adverse events

Collected over 19 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Test Condom A - Males0/150 (0%)0/150 (0%)0/150 (0%)
Test Condom B - Males0/150 (0%)0/150 (0%)8/150 (5.3%)
Control NRL Condom - Males0/150 (0%)0/150 (0%)0/150 (0%)
Baseline - Males0/150 (0%)0/150 (0%)11/150 (7.3%)
Test Condom A - Females0/150 (0%)0/150 (0%)0/150 (0%)
Test Condom B - Females0/150 (0%)0/150 (0%)0/150 (0%)
Control NRL Condom - Females0/150 (0%)0/150 (0%)0/150 (0%)
Baseline - Females0/150 (0%)0/150 (0%)0/150 (0%)
Most frequent other events
Most frequent other events
EventTest Condom A - MalesTest Condom B - MalesControl NRL Condom - MalesBaseline - MalesTest Condom A - FemalesTest Condom B - FemalesControl NRL Condom - FemalesBaseline - Females
NasopharyngitisInfections and infestations0/1508/1500/15011/1500/1500/1500/1500/150

Baseline characteristics

150 couples were enrolled. Age and safety were collected for both male and female participants. Other endpoints were analyzed for male participants' data only.

Age, Customized
Age, Customized(years)Overall Study
Male Participants33.94 ± 10.38
Female Participants32.11 ± 10.14
Sex: Female, Male
Sex: Female, Male(Participants)Overall Study
Female150
Male150
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Overall Study
Caucasian138
Asian7
Black1
Other4
08

Study locations

1 site
  • SGS proderm GmbH
    Hamburg, Germany
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — IPD will be shared as per local regulations.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05840172
Responsible party
Sponsor
First posted
May 3, 2023
Start date
Oct 19, 2023
Primary completion
Oct 7, 2024
Completion
Oct 7, 2024
Results posted
May 7, 2026
Last update
May 7, 2026

Study contacts

Kirstin Deuble-Bente, MD
principal investigator · SGS proderm GmbH

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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