An interventional study of Polyurethane (PU) male condom-Test condom 1- PU 57 mm and Polyurethane (PU) male condom-Test condom 2- PU 63 mm in Contraception, sponsored by Reckitt Benckiser Healthcare (UK) Limited. Completed at 3 sites in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by Reckitt Benckiser Healthcare (UK) Limited (part of Reckitt) · Not applicable, Interventional, and Prevention
This investigation is designed to evaluate the performance rate of two polyurethane male condoms with different sizes and thicknesses versus a standard natural rubber latex (NRL) male condom.
The purpose of this study is to see how well the experimental condoms perform compared to the latex rubber condom (for example, how often the different condom types break or slip off the penis).
Sponsor also wants to find out how well couples like using the three condom types and whether they experience any problems when using the condoms (for example, irritation or discomfort).
In this clinical investigation, new two PU male condoms (test condoms) will be evaluated against a marketed NRL male condom (control condom). This clinical investigation will also evaluate the in-use tolerance of the test and control condoms.
Reckitt Benckiser Healthcare (UK) Limited is the lead sponsor of 35 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
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.
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).
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Following randomisation, couples received a carton of Test Condom 1 (polyurethane \[PU\], 57 mm) for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
Device: Polyurethane (PU) male condom-Test condom 1- PU 57 mm
Following randomisation, couples received a carton of Test Condom 2 (polyurethane \[PU\], 63 mm) for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
Device: Polyurethane (PU) male condom-Test condom 2- PU 63 mm
Following randomisation, couples received a carton of Control condom: Natural Rubber Latex (NRL) 57 mm for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
Device: Natural Rubber Latex (NRL) male condom- Control condom
A minimum of 5 condoms of each condom type will be provided to couples to be used during vaginal intercourse over a maximum 5-week period (assessment period). Couples will repeat the assessment period for each of the 3 condom types.
A minimum of 5 condoms of each condom type will be provided to couples to be used during vaginal intercourse over a maximum 5-week period (assessment period). Couples will repeat the assessment period for each of the 3 condom types.
A minimum of 5 condoms of each condom type will be provided to couples to be used during vaginal intercourse over a maximum 5-week period (assessment period). Couples will repeat the assessment period for each of the 3 condom types.
Total Clinical Failure Rate of Polyurethane (PU) Male (Test Condom 1: PU 57 mm) Condom Compared to Control Condom: Natural Rubber Latex (NRL) 57 mm Male Condom.
The total clinical failure rate (combined breakage and slippage) of PU male test condom (Test condom 1) compared to the NRL male control condom. Clinical failure rate is calculated as the number of condoms with at least 1 acute clinical failure event divided by the number of condoms used during intercourse, reported as a percentage. Clinical failure events, defined in ISO 29943-1:2017, reported by participants.
Time frame: within 8 hours following each coital act for each condom use
Total Clinical Failure Rate of Polyurethane (PU) Male (Test Condom 2: PU 63 mm) Condom Compared to Control Condom: Natural Rubber Latex (NRL) 57 mm Male Condom.
The total clinical failure rate (combined breakage and slippage) of PU male test condom (Test condom 2) compared to the NRL male control condom. Clinical failure rate is calculated as the number of condoms with at least 1 acute clinical failure event divided by the number of condoms used during intercourse, reported as a percentage. Clinical failure events, defined in ISO 29943-1:2017, reported by participants.
Time frame: within 8 hours following each coital act for each condom use
Clinical Breakage Rate of PU Male Test Condom 1 Compared to NRL Male Control Condom
The total clinical breakage rate of the PU male test condom (Test condom 1) compared to the NRL male control condom when used during vaginal intercourse. The total clinical breakage rate is determined from the number of condoms broken or torn during vaginal intercourse or withdrawal from the vagina divided by the number of condoms used during intercourse, reported as a percentage.
Time frame: within 8 hours following each coital act for each condom use
Clinical Slippage Rate of PU Male Test Condom 1 Compared to NRL Male Control Condom
The total clinical slippage rate of the PU male test condom (Test condom 1) compared to the NRL male control condom when used during vaginal intercourse. The total clinical slippage rate is determined from the number of condoms that slipped completely off the penis during intercourse or withdrawal from the vagina, divided by the number of condoms used during vaginal intercourse, reported as a percentage.
Time frame: within 8 hours following each coital act for each condom use
Clinical Breakage Rate of PU Male Test Condom 2 Compared to NRL Male Control Condom
The total clinical breakage rate of the PU male test condom (Test condom 2) compared to the NRL male control condom when used during vaginal intercourse. The total clinical breakage rate is determined from the number of condoms broken or torn during vaginal intercourse or withdrawal from the vagina divided by the number of condoms used during intercourse, reported as a percentage.
Time frame: within 8 hours following each coital act for each condom use
Clinical Slippage Rate of PU Male Test Condom 2 Compared to NRL Male Control Condom
The total clinical slippage rate of the PU male test condom (Test condom 2) compared to the NRL male control condom when used during vaginal intercourse.
Time frame: within 8 hours following each coital act for each condom use
Non-clinical Breakage Rate for Each of the PU Male Condoms (Test Condom 1 and Test Condom 2) and the NRL Male Control Condom.
The total non-clinical breakage for each of the PU male test condom and the NRL male control condom when used during vaginal intercourse.
Time frame: within 8 hours following each coital act for each condom use
Non-clinical Slippage Respectively of Each PU Male Test Condom (Test Condom 1 and Test Condom 2) and the NRL Male Control Condom.
The total non-clinical slippage rate for each of the PU male test condoms and the NRL male control condom when used during vaginal intercourse.
Time frame: within 8 hours following each coital act for each condom use
User Acceptability/In-use Tolerability of the 2 PU Male Test Condoms (Test Condom 1 and Test Condom 2) and the NRL Male Control Condom.
User acceptability, experience, and preference for each condom type will be evaluated through participant-perceived questions. Participant's experience on the use of each type of condoms \[Acceptability as assessed by participant perceived questionnaires-End of Condom Use Period Questionnaire (ECUPQ) (designed by following ISO 29943-1). ECUPQ uses a 10 point scale with 1 representing agreement 'to the least degree (not at all)' and 10 agree 'to the most degree'.
Time frame: within 8 hours following each coital act for each condom use
| Milestone | Sequence 1 | Sequence 2 | Sequence 3 | Sequence 4 | Sequence 5 | Sequence 6 |
|---|---|---|---|---|---|---|
| Started | 51 | 49 | 50 | 49 | 50 | 50 |
| Treated | 48 | 44 | 46 | 48 | 47 | 50 |
| Treated (male participants) | 48 | 44 | 46 | 48 | 47 | 50 |
| Treated (female participants) | 48 | 44 | 46 | 48 | 47 | 50 |
| Completed | 45 | 38 | 41 | 41 | 42 | 43 |
| Not completed | 6 | 11 | 9 | 8 | 8 | 7 |
The total clinical failure rate (combined breakage and slippage) of PU male test condom (Test condom 1) compared to the NRL male control condom. Clinical failure rate is calculated as the number of condoms with at least 1 acute clinical failure event divided by the number of condoms used during intercourse, reported as a percentage. Clinical failure events, defined in ISO 29943-1:2017, reported by participants.
| % Clinical failure | Test Condom 1: Polyurethane (PU) 57 mm | Control Condom: Natural Rubber Latex (NRL) 57 mm |
|---|---|---|
| Total Clinical Failure Rate of Polyurethane (PU) Male (Test Condom 1: PU 57 mm) Condom Compared to Control Condom: Natural Rubber Latex (NRL) 57 mm Male Condom. | 3.08 (1.71 to 4.45) | 2.48 (1.23 to 3.73) |
The total clinical failure rate (combined breakage and slippage) of PU male test condom (Test condom 2) compared to the NRL male control condom. Clinical failure rate is calculated as the number of condoms with at least 1 acute clinical failure event divided by the number of condoms used during intercourse, reported as a percentage. Clinical failure events, defined in ISO 29943-1:2017, reported by participants.
| % clinical failure. | Test Condom 2: Polyurethane (PU) 63 mm | Control Condom: Natural Rubber Latex (NRL) 57 mm |
|---|---|---|
| Total Clinical Failure Rate of Polyurethane (PU) Male (Test Condom 2: PU 63 mm) Condom Compared to Control Condom: Natural Rubber Latex (NRL) 57 mm Male Condom. | 2.97 (1.61 to 4.33) | 2.48 (1.23 to 3.73) |
The total clinical breakage rate of the PU male test condom (Test condom 1) compared to the NRL male control condom when used during vaginal intercourse. The total clinical breakage rate is determined from the number of condoms broken or torn during vaginal intercourse or withdrawal from the vagina divided by the number of condoms used during intercourse, reported as a percentage.
| % clinical breakage rate | Test Condom 1: Polyurethane (PU) 57 mm | Control Condom: Natural Rubber Latex (NRL) 57 mm |
|---|---|---|
| Clinical Breakage Rate of PU Male Test Condom 1 Compared to NRL Male Control Condom | 0.91 (0.30 to 1.53) | 1.0 (0.37 to 1.64) |
The total clinical slippage rate of the PU male test condom (Test condom 1) compared to the NRL male control condom when used during vaginal intercourse. The total clinical slippage rate is determined from the number of condoms that slipped completely off the penis during intercourse or withdrawal from the vagina, divided by the number of condoms used during vaginal intercourse, reported as a percentage.
| % clinical slippage rate | Test Condom 1: Polyurethane (PU) 57 mm | Control Condom: Natural Rubber Latex (NRL) 57 mm |
|---|---|---|
| Clinical Slippage Rate of PU Male Test Condom 1 Compared to NRL Male Control Condom | 2.87 (1.50 to 4.24) | 1.05 (0.09 to 2.02) |
The total clinical breakage rate of the PU male test condom (Test condom 2) compared to the NRL male control condom when used during vaginal intercourse. The total clinical breakage rate is determined from the number of condoms broken or torn during vaginal intercourse or withdrawal from the vagina divided by the number of condoms used during intercourse, reported as a percentage.
| % clinical breakage rate | Test Condom 2: Polyurethane (PU) 63 mm | Control Condom: Natural Rubber Latex (NRL) 57 mm |
|---|---|---|
| Clinical Breakage Rate of PU Male Test Condom 2 Compared to NRL Male Control Condom | 0.13 (-0.05 to 0.31) | 1.0 (0.37 to 1.64) |
The total clinical slippage rate of the PU male test condom (Test condom 2) compared to the NRL male control condom when used during vaginal intercourse.
| % clinical slippage rate | Test Condom 2: Polyurethane (PU) 63 mm | Control Condom: Natural Rubber Latex (NRL) 57 mm |
|---|---|---|
| Clinical Slippage Rate of PU Male Test Condom 2 Compared to NRL Male Control Condom | 2.43 (1.16 to 3.71) | 1.05 (0.09 to 2.02) |
The total non-clinical breakage for each of the PU male test condom and the NRL male control condom when used during vaginal intercourse.
| Non-clinical breakage | Test Condom 1: Polyurethane (PU) 57 mm | Test Condom 2: Polyurethane (PU) 63 mm | Control Condom: Natural Rubber Latex (NRL) 57 mm |
|---|---|---|---|
| Non-clinical Breakage Rate for Each of the PU Male Condoms (Test Condom 1 and Test Condom 2) and the NRL Male Control Condom. | 18 | 6 | 11 |
The total non-clinical slippage rate for each of the PU male test condoms and the NRL male control condom when used during vaginal intercourse.
| Number of non-clinical slippage | Test Condom 1: Polyurethane (PU) 57 mm | Test Condom 2: Polyurethane (PU) 63 mm | Control Condom: Natural Rubber Latex (NRL) 57 mm |
|---|---|---|---|
| Non-clinical Slippage Respectively of Each PU Male Test Condom (Test Condom 1 and Test Condom 2) and the NRL Male Control Condom. | 168 | 245 | 149 |
User acceptability, experience, and preference for each condom type will be evaluated through participant-perceived questions. Participant's experience on the use of each type of condoms \[Acceptability as assessed by participant perceived questionnaires-End of Condom Use Period Questionnaire (ECUPQ) (designed by following ISO 29943-1). ECUPQ uses a 10 point scale with 1 representing agreement 'to the least degree (not at all)' and 10 agree 'to the most degree'.
| ECUPQ overall liking score (1-10) | Test Condom 1: Polyurethane (PU) 57 mm | Test Condom 2: Polyurethane (PU) 63 mm | Control Condom: Natural Rubber Latex (NRL) 57 mm |
|---|---|---|---|
| Overall liking of each condom type assessed using Question 1.1 of ECUPQ (Male participants) | 6.2 ± 2.57 | 6.6 ± 2.17 | 6.2 ± 2.36 |
| Overall liking of each condom type assessed using Question 1.1 of ECUPQ (Female participants) | 6.7 ± 2.39 | 6.9 ± 2.05 | 6.4 ± 2.26 |
Collected over From first use of study condom through end of the clinical investigation. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test Condom 1: Polyurethane (PU) 57 mm- Male | 0/260 (0%) | 0/260 (0%) | 5/260 (1.9%) |
| Test Condom 1: Polyurethane (PU) 57 mm- Female | 0/260 (0%) | 0/260 (0%) | 9/260 (3.5%) |
| Test Condom 2: Polyurethane (PU) 63 mm- Male | 0/264 (0%) | 1/264 (0.4%) | 11/264 (4.2%) |
| Test Condom 2: Polyurethane (PU) 63 mm- Female | 0/264 (0%) | 0/264 (0%) | 10/264 (3.8%) |
| Control Condom: Natural Rubber Latex (NRL) 57 mm- Male | 1/266 (0.4%) | 1/266 (0.4%) | 6/266 (2.3%) |
| Control Condom: Natural Rubber Latex (NRL) 57 mm- Female | 0/266 (0%) | 0/266 (0%) | 8/266 (3%) |
| Event | Test Condom 1: Polyurethane (PU) 57 mm- Male | Test Condom 1: Polyurethane (PU) 57 mm- Female | Test Condom 2: Polyurethane (PU) 63 mm- Male | Test Condom 2: Polyurethane (PU) 63 mm- Female | Control Condom: Natural Rubber Latex (NRL) 57 mm- Male | Control Condom: Natural Rubber Latex (NRL) 57 mm- Female |
|---|---|---|---|---|---|---|
| appendicitisInfections and infestations | 0/260 | 0/260 | 1/264 | 0/264 | 1/266 | 0/266 |
| suicidePsychiatric disorders | 0/260 | 0/260 | 1/264 | 0/264 | 1/266 | 0/266 |
| Event | Test Condom 1: Polyurethane (PU) 57 mm- Male | Test Condom 1: Polyurethane (PU) 57 mm- Female | Test Condom 2: Polyurethane (PU) 63 mm- Male | Test Condom 2: Polyurethane (PU) 63 mm- Female | Control Condom: Natural Rubber Latex (NRL) 57 mm- Male | Control Condom: Natural Rubber Latex (NRL) 57 mm- Female |
|---|---|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 1/260 | 1/260 | 5/264 | 2/264 | 3/266 | 0/266 |
| Fungal infectionInfections and infestations | 0/260 | 3/260 | 0/264 | 1/264 | 0/266 | 0/266 |
| Lower respiratory tractInfections and infestations | 2/260 | 2/260 | 0/264 | 1/264 | 0/266 | 1/266 |
| Upper respiratory tractInfections and infestations | 0/260 | 0/260 | 2/264 | 2/264 | 0/266 | 0/266 |
| Atypical pneumoniaInfections and infestations | 0/260 | 1/260 | 0/264 | 0/264 | 0/266 | 0/266 |
| VaricellaInfections and infestations | 0/260 | 1/260 | 0/264 | 0/264 | 0/266 | 0/266 |
| SeizureNervous system disorders | 0/260 | 1/260 | 0/264 | 0/264 | 0/266 | 0/266 |
| AcneSkin and subcutaneous tissue disorders | 0/260 | 1/260 | 0/264 | 0/264 | 0/266 | 0/266 |
| RashSkin and subcutaneous tissue disorders | 1/260 | 0/260 | 0/264 | 0/264 | 0/266 | 1/266 |
| Limb injuryInjury, poisoning and procedural complications | 1/260 | 0/260 | 1/264 | 0/264 | 0/266 | 0/266 |
283 is the number of couples in Full Analysis Set population. The data presented here represents male and females participants.
| Age, Continuous(Years) | Sequence 1 | Sequence 2 | Sequence 3 | Sequence 4 | Sequence 5 | Sequence 6 | Total |
|---|---|---|---|---|---|---|---|
| Male Age | 34.0 ± 7.53 | 31.5 ± 5.33 | 33.1 ± 7.20 | 33.5 ± 6.63 | 33.0 ± 6.54 | 31.6 ± 6.45 | 32.8 ± 6.67 |
| Female Age | 32.3 ± 7.23 | 30.0 ± 5.19 | 31.5 ± 7.33 | 33.5 ± 6.70 | 31.9 ± 6.82 | 30.5 ± 5.68 | 31.6 ± 6.58 |
| Sex: Female, Male(Participants) | Sequence 1 | Sequence 2 | Sequence 3 | Sequence 4 | Sequence 5 | Sequence 6 | Total |
|---|---|---|---|---|---|---|---|
| Female | 48 | 44 | 46 | 48 | 47 | 50 | 283 |
| Male | 48 | 44 | 46 | 48 | 47 | 50 | 283 |
| Race/Ethnicity, Customized(participants (can choose multiple)) | Sequence 1 | Sequence 2 | Sequence 3 | Sequence 4 | Sequence 5 | Sequence 6 | Total |
|---|---|---|---|---|---|---|---|
| White, not Hispanic/Latino-Male | 25 | 27 | 27 | 24 | 21 | 30 | 154 |
| Hispanic/Latino- Male | 10 | 8 | 13 | 14 | 15 | 13 | 73 |
| African American- Male | 4 | 4 | 2 | 3 | 1 | 4 | 18 |
| Asian or Pacific Islander-Male | 9 | 11 | 4 | 8 | 9 | 8 | 49 |
| Native American- Male | 1 | 1 | 1 | 0 | 0 | 1 | 4 |
| Other- Male | 3 | 0 | 0 | 2 | 1 | 0 | 6 |
| White, not Hispanic/Latino- Female | 24 | 18 | 29 | 22 | 23 | 28 | 144 |
| Hispanic/Latino- Female | 13 | 11 | 12 | 15 | 15 | 14 | 80 |
| African American- Female | 4 | 6 | 1 | 4 | 1 | 2 | 18 |
| Asian or Pacific Islander-Female | 9 | 11 | 6 | 9 | 10 | 10 | 55 |
| Native American- Female | 2 | 1 | 0 | 0 | 0 | 0 | 3 |
| Other- Female | 2 | 1 | 2 | 0 | 2 | 2 | 9 |
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