ContraceptionNCT06557499
A 3-way Crossover Clinical Investigation to Assess the Performance of Two Different Sized Polyurethane Condoms Versus a Latex Condom in Healthy Monogamous Couples.
A study testing Polyurethane (PU) male condom-Test condom 1- PU 57 mm and Polyurethane (PU) male condom-Test condom 2- PU 63 mm in people with Contraception, run by Reckitt Benckiser Healthcare (UK) Limited at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Polyurethane (PU) male condom-Test condom 1- PU 57 mm and Polyurethane (PU) male condom-Test condom 2- PU 63 mm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 598 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Aug 2024to 11 Jul 2025
- 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
Who may be able to join
- Both partners participating must provide written informed consent.
- Couples must include a male and female within a heterosexual couple and be between 18 - 60 years of age inclusive.
- Both partners must be willing to respond to questions about their reproductive and contraceptive history and use of condoms during interviews and respond to self-administered questionnaires as per instructions.
- Both partners must agree to answer the questions in the condom use questionnaires and two scales as soon as possible and within 2 (+6) hours following each coital act.
- Both partners must be generally healthy and in a mutually monogamous heterosexual relationship - current relationship ≥ 3 months.
- All couples must be averaging one act of intercourse weekly, agree to have penile-vaginal intercourse with a frequency sufficient to meet CIP requirements (a minimum of 5 coital acts over 5 weeks per assessment period-).
Show all 18Show fewer
- The female partner must also use an established (as agreed by the Investigator) other highly effective form of non-barrier contraception, unless post-menopausal (confirmed menopausal prior to screening, amenorrhea for at least 12 months after cessation of exogenous hormone treatment) in which case no second form of contraception is required. Highly effective non-barrier contraception includes oral contraceptive (oestrogen and progestogen or progestogen-only hormonal contraception associated with inhibition of ovulation), intra-uterine device (IUD) or intra-uterine system (IUS), hormonal implant, injectables, patch and or sterilization of at least one partner (i.e., bilateral tubal ligation, vasectomy deemed medically successful).
- Both partners must be able to understand instructions for correct use of condoms.
- Both partners must have an adequate level of literacy to understand and to be able to answer the questionnaires.
- Both partners must agree to use only the investigational condoms during the time of participation.
- Participants must agree to use the penis measuring kit provided to measure the erect penis at investigation start.
- Both partners must agree not to use drugs or non-investigational devices that can affect sexual performance.
- Both partners must have no known sexually transmitted infections including Human Immunodeficiency Virus (HIV) / acquired immune deficiency syndrome (AIDS) (medical history via self-report) (uncomplicated Herpes simplex virus (HSV) and positive Human papillomavirus (HPV) which areis asymptomatic may be included in the investigation study in the opinion of the Investigator).
- Both partners must agree to use only lubricant(s) provided for the duration of investigation.
- Both partners must agree not to wear any genital piercing jewellery for the duration of the clinical investigation.
- Both partners must have no past medical history of any health condition (self-reported) that, in the opinion of the Investigator, would be considered clinically relevant.
- Couples must have a compatible electronic device with internet access which they are willing to upload questionnaire data to the web-based platform throughout the investigation.
- Both partners will be available for follow-up.
Who cannot join
- Either partner is or becomes aware of an allergy or sensitivity to the ingredients of any of the products, including the test or control condoms or any lubrication products provided.
- Either partner has been receiving daily treatment for their pre-existing skin condition (for example, severe eczema/psoriasis) within the three months prior to the screening for this study.
- Female partner that is pregnant or desires to become so while participating in investigation, (females of childbearing potential must have a negative pregnancy test as part of screening).
- Any couple undergoing any form of fertility treatment such as in-vitro fertilisation.
- Either partner needs to use condoms for sexually transmitted infection (STI) protection (e.g., discordance for Human Immunodeficiency Virus (HIV) or herpes).
- Either partner has previous or planned genital surgery that in the opinion of the Investigator would consider the participant unsuitable to participate in the clinical investigation (e.g., laser for abnormal smear).
Show all 20Show fewer
- Either partner are commercial sex workers.
- Either partner are itinerant persons who will be unable to complete the clinical investigation (e.g., migrant farm workers).
- Couples that in the opinion of the Investigator, would be unable to complete the investigation.
- Male partners that have known erectile or ejaculatory dysfunction in the past month.
- Either partner requires to use/ is using medication or preparations that are applied topically to the genitalia area or intravaginally, other than that supplied for the investigation.
- A female partner that has been diagnosed with or treated for vaginal complaints (including vaginal dryness) in the previous 3 months which, in the opinion of the Investigator, deems the partner unsuitable for the investigation.
- Either partner uses any medication which in the investigator's opinion may interfere with the use of condoms.
- A male partner with abnormal penile anatomy or genital lesion (e.g., balanoposthitis) that would, in the opinion of the Investigator, affect the ability to keep the condom in place during intercourse.
- Either partner is suffering from any health conditions (self-reported) or any condition which could, in the opinion of the Investigator, affect the outcome of the investigation or affect their safety if they participate.
- Either partner have participated in a clinical trial in the previous month which could, in the opinion of the Investigator, affect the outcome of the investigation.
- Either partner is an employee of the investigational Sponsor or affiliated with the clinical research centre (i.e., enrolment of the Investigator, his/ her family members, employees and other dependent persons).
- Either partner has a recent history of drug/alcohol abuse within the previous 12 months.
- Either partner has an inability to follow the procedures of the investigation, (e.g., due to language problems, psychological disorders, health conditions such as dementia).
- Either partner is unable, in the opinion of the Investigator, to fully comply with the investigation requirements.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Essential Access Health-Berkeley
Berkeley, California, 90010
Essential Access Health -Los Angeles
Los Angeles, California, 90017
Essential Acess Health- Seattle
Seattle, Washington, 98005
About this study
Official title: A Randomized, Data Analyst-masked, 3-way Cross-over, Pivotal Clinical Investigation to Evaluate the Performance of Two Polyurethane Male Condoms With Different Size and Thickness in Healthy Monogamous Couples During Vaginal Intercourse Compared With a Commercially Available Thin Latex Male Condom.
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).
Read the detailed description
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.
- Conditions
- Contraception
- Being tested
- Polyurethane (PU) male condom-Test condom 1- PU 57 mm, Polyurethane (PU) male condom-Test condom 2- PU 63 mm, Natural Rubber Latex (NRL) male condom- Control condom
- Keywords
- Condoms, Slippage, Breakage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyurethane (PU) male condom-Test condom 1- PU 57 mmDevice
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.
Polyurethane (PU) male condom-Test condom 2- PU 63 mmDevice
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.
Natural Rubber Latex (NRL) male condom- Control condomDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Test Condom 1- Polyurethane (PU) 57 mm | Experimental | 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 Receives: Device: Polyurethane (PU) male condom-Test condom 1- PU 57 mm |
| Test Condom 1- Polyurethane (PU) 63 mm | Experimental | 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 Receives: Device: Polyurethane (PU) male condom-Test condom 2- PU 63 mm |
| Control Condom: Natural Rubber Latex (NRL) 57 mm | Active comparator | 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 Receives: Device: Natural Rubber Latex (NRL) male condom- Control condom |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: within 8 hours following each coital act for each condom use
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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'.
Measured: within 8 hours following each coital act for each condom use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start23 Aug 2024
- Primary completion11 Jul 2025
- Study completion11 Jul 2025
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 ContraceptionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The condom types will be tested in a 3-way cross-over design where couples will be randomised to use each of the 3 condom types in a defined order, according to the randomisation schedule.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 598 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Responsible party
- Sponsor
- Investigators
- Terri Walsh, Principal investigator, Essential Access Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557499
- Sponsor's protocol ID
- 2628301
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2024
- Last updated
- 24 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Data Analyst-masked, 3-way Cross-over, Pivotal Clinical Investigation to Evaluate the Performance of Two Polyurethane Male Condoms With Different Size and Thickness in Healthy Monogamous Couples During Vaginal Intercourse Compared With a Commercially Available Thin Latex Male Condom.
- ClinicalTrials.gov ID
- NCT06557499
- Acronym / sponsor ID
- 2628301
- Conditions
- Contraception
- Keywords
- Condoms, Slippage, Breakage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 598 participants (actual)
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Study start
- 23 Aug 2024 (actual)
- Primary completion
- 11 Jul 2025 (actual)
- Study completion
- 11 Jul 2025 (actual)
- First posted
- 16 Aug 2024 (actual)
- Results
- Posted 24 Jul 2026
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 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).
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- The condom types will be tested in a 3-way cross-over design where couples 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 1- Polyurethane (PU) 57 mm | Experimental | Device: Polyurethane (PU) male condom-Test condom 1- PU 57 mmFollowing 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 |
| Test Condom 1- Polyurethane (PU) 63 mm | Experimental | Device: Polyurethane (PU) male condom-Test condom 2- PU 63 mmFollowing 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 |
| Control Condom: Natural Rubber Latex (NRL) 57 mm | Active comparator | Device: Natural Rubber Latex (NRL) male condom- Control condomFollowing 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Both partners participating must provide written informed consent.
- Couples must include a male and female within a heterosexual couple and be between 18 - 60 years of age inclusive.
- Both partners must be willing to respond to questions about their reproductive and contraceptive history and use of condoms during interviews and respond to self-administered questionnaires as per instructions.
- Both partners must agree to answer the questions in the condom use questionnaires and two scales as soon as possible and within 2 (+6) hours following each coital act.
- Both partners must be generally healthy and in a mutually monogamous heterosexual relationship - current relationship ≥ 3 months.
Key exclusion criteria (20 listed)
- Either partner is or becomes aware of an allergy or sensitivity to the ingredients of any of the products, including the test or control condoms or any lubrication products provided.
- Either partner has been receiving daily treatment for their pre-existing skin condition (for example, severe eczema/psoriasis) within the three months prior to the screening for this study.
- Female partner that is pregnant or desires to become so while participating in investigation, (females of childbearing potential must have a negative pregnancy test as part of screening).
- Any couple undergoing any form of fertility treatment such as in-vitro fertilisation.
- Either partner needs to use condoms for sexually transmitted infection (STI) protection (e.g., discordance for Human Immunodeficiency Virus (HIV) or herpes).
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 |
|---|---|---|
| Polyurethane (PU) male condom-Test condom 1- PU 57 mmA 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. | Device | Test Condom 1- Polyurethane (PU) 57 mm |
| Polyurethane (PU) male condom-Test condom 2- PU 63 mmA 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. | Device | Test Condom 1- Polyurethane (PU) 63 mm |
| Natural Rubber Latex (NRL) male condom- Control condomA 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. | Device | Control Condom: Natural Rubber Latex (NRL) 57 mm |
Primary outcome
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.
Time frame: within 8 hours following each coital act for each condom use
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.
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.
Time frame: within 8 hours following each coital act for each condom use
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.
7 secondary outcomes
Clinical Breakage Rate of PU Male Test Condom 1 Compared to NRL Male Control Condom
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
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
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
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.
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.
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.
Time frame: within 8 hours following each coital act for each condom use
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Contraception
Enrolling by invitation
Flo Digital Contraceptive Study
Contraception Use
Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingObservational study
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
Alcohol Use, Alcohol Consumption
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
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.
Terri Walsh principal investigator
Essential Access Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyurethane (PU) male condom-Test condom 1- PU 57 mm and Polyurethane (PU) male condom-Test condom 2- PU 63 mm in people with Contraception, run by Reckitt Benckiser Healthcare (UK) Limited at 3 sites in United States.
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 18 inclusion and 20 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: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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. 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 24 Jul 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?
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. (time frame: within 8 hours following each coital act for each condom use). The study lists 2 primary outcomes in all. 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 24 Jul 2026.