Control of PregnancyPhase 4NCT04134039
A Clinical Investigation to Assess the Performance of a Polyurethane Condom Versus a Latex Condom in Healthy Monogamous Couples
A Phase 4 study testing Polyurethane (PU) condom and Natural Rubber Latex (NRL) condom in people with Control of Pregnancy and Prevention of Sexually Transmitted Infections, run by Reckitt Benckiser Healthcare (UK) Limited at 1 site in Thailand.
Trial summary
This investigation is designed to evaluate the performance rate of a polyurethane (PU) condom versus a standard natural rubber latex (NRL) condom. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Control of Pregnancy, Prevention of Sexually Transmitted Infections
- What is being tested?
- Polyurethane (PU) condom and Natural Rubber Latex (NRL) condom
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- 1 siteThailand
- Study dates
- 9 Feb 2021to 5 Jul 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Main Inclusion Criteria:
- A male and a female subject aged: 18 - 60 years inclusive.
- All subjects must be generally healthy and in a mutually monogamous heterosexual relationship - current relationship ≥ 3 months.
- All couples must be sexually active and agree to have penile-vaginal intercourse with a frequency sufficient to meet protocol requirements (a minimum of 5 coital acts over 4 weeks).
- The female partner should already be on an established highly effective form of non-barrier contraception, unless post-menopausal.
- Couples must agree not to use drugs or non-investigational devices that can affect sexual performance.
Main Exclusion Criteria:
- Either partner is or becomes aware of an allergy or sensitivity to the ingredients of the test products, including the test or reference condoms.
- Either partner has a pre-existing skin condition (severe eczema/ psoriasis) or systemic allergic reactions or as confirmed by the subject and physical examination.
- Either partner that needs to use condoms for a specific sexually transmitted infection (STI) protection e.g. discordance for Human Immunodeficiency Virus (HIV) or herpes.
- Subjects that have previous or planned genital surgery, that in the opinion of the Investigator would consider the subject unsuitable to participate in the clinical investigation e.g. laser for abnormal smear.
- Male partners that have known erectile or ejaculatory dysfunction.
- 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.
- Any subject who has clinical symptoms or signs of a sexually transmitted diseases (STD) or HIV/ AIDS or has a previous history of high-risk behaviour as judged by the investigator.
- Female partner using medication which in the investigator's opinion would affect vaginal mucosal secretion, such as Chlorpheniramine at any time in the 14 days (or 5 half-lives of the drug, whichever is longer) before first condom use.
- A male partner with abnormal penile anatomy that would, in the opinion of the investigator, affect the ability to keep the condom in place during intercourse.
- Either partner intends to continue to use antihistamines, anti-inflammatory drugs or pain killers for the duration of the investigation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Assessor-masked, 2-way Cross-over, Multi-centre, Clinical Investigation to Evaluate the Performance Rate of a Polyurethane Condom in Healthy Monogamous Couples When Compared With a Standard Latex Condom
This investigation is designed to evaluate the performance rate of a polyurethane (PU) condom versus a standard natural rubber latex (NRL) condom.
Read the detailed description
In this clinical investigation, a new PU male condom (test condom) will be evaluated against a marketed NRL male condom (reference condom). This clinical investigation will also evaluate the in-use tolerance of the test and reference condoms.
- Being tested
- Polyurethane (PU) condom, Natural Rubber Latex (NRL) condom
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyurethane (PU) condomDevice
A minimum of 5 condoms (maximum 7 condoms) of each condom type will be provided to couples to be used during vaginal intercourse over a 4 week period, the assessment period. Couples will repeat the assessment period each of the 2 condom types.
Natural Rubber Latex (NRL) condomDevice
A minimum of 5 condoms (maximum 7 condoms) of each condom type will be provided to couples to be used during vaginal intercourse over a 4 week period, the assessment period. Couples will repeat the assessment period each of the 2 condom types.
| Study group | Role | What they receive |
|---|---|---|
| Polyurethane (PU) condom | Experimental | Following randomisation each couple will be given one set of 7 condoms as per randomisation schedule. After use of at least 5 condoms, couples will return to the clinic site for collection of their next set of condoms. Each couple will test a maximum of 14 condoms during their participation in the investigation. Receives: Device: Polyurethane (PU) condom; Device: Natural Rubber Latex (NRL) condom |
| Natural Rubber Latex (NRL) condom | Experimental | Following randomisation each couple will be given one set of 7 condoms as per randomisation schedule. After use of at least 5 condoms, couples will return to the clinic site for collection of their next set of condoms. Each couple will test a maximum of 14 condoms during their participation in the investigation. Receives: Device: Polyurethane (PU) condom; Device: Natural Rubber Latex (NRL) condom |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compared clinical failure rate of condom use between the test condom group and the reference condom group
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, will be reported by subjects.
Measured: within 2 hours following each coital act for each condom use
Secondary outcomes (6)
Performance (clinical slippage rate) of the Polyurethane (PU) condom
Clinical slippage rate is calculated as the number of condoms with at least 1 clinical slippage event divided by the number of condoms used during intercourse, reported as a percentage. Clinical slippage events, defined in ISO 29943-1:2017, will be reported by subjects.
A clinical slippage is defined as a condom slipping off completely during intercourse or during withdrawal from the vagina. Slippage that occur because the user failed to hold onto the condom at the base of the penis during withdrawal and/ or because the user delayed withdrawal after sex are to be record as "non-clinical slippage", these events are considered user failures.
Measured: within 2 hours following each coital act for each condom use
Performance (clinical slippage rate) of the Natural Rubber Latex (NRL) condom
Clinical slippage rate is calculated as the number of condoms with at least 1 clinical slippage event divided by the number of condoms used during intercourse, reported as a percentage. Clinical slippage events, defined in ISO 29943-1:2017, will be reported by subjects.
A clinical slippage is defined as a condom slipping off completely during intercourse or during withdrawal from the vagina. Slippage that occur because the user failed to hold onto the condom at the base of the penis during withdrawal and/ or because the user delayed withdrawal after sex are to be record as "non-clinical slippage", these events are considered user failures.
Measured: within 2 hours following each coital act for each condom use
Performance (clinical breakage rate) of the Polyurethane (PU) condom
Clinical failure rate is calculated as the number of condoms with at least 1 acute clinical failure event (clinical slippage or clinical breakage) divided by the number of condoms used during intercourse, reported as a percentage. Clinical failure events, defined in ISO 29943-1:2017, will be reported by subjects.
Measured: within 2 hours following each coital act for each condom use
Performance (clinical breakage rate) of the Natural Rubber Latex (NRL) condom
Clinical failure rate is calculated as the number of condoms with at least 1 acute clinical failure event (clinical slippage or clinical breakage) divided by the number of condoms used during intercourse, reported as a percentage. Clinical failure events, defined in ISO 29943-1:2017, will be reported by subjects.
Measured: within 2 hours following each coital act for each condom use
Incidence of treatment-emergent adverse events and adverse device effects, defined in MEDDEV 2.7/3
Measured: 12 weeks
Subject's experience on the use of each type of condoms [Acceptability and Tolerability
Acceptability and tolerability as assessed by subject perceived questionnaires (designed by following ISO 29943-1)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start9 Feb 2021
- Primary completion5 Jul 2021
- Study completion5 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Control of PregnancyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The condom types will be tested in a 2-way cross-over design where couples will be randomised to use each of the 2 condom types in a defined order, according to the randomisation schedule.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 470 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
- Unnop Jaisamrarn, MD, Principal investigator, King Chulalongkorn Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04134039
- Sponsor's protocol ID
- 1003201
- Status last verified
- Sep 2021
- First submitted
- 11 Oct 2019
- Last updated
- 16 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Assessor-masked, 2-way Cross-over, Multi-centre, Clinical Investigation to Evaluate the Performance Rate of a Polyurethane Condom in Healthy Monogamous Couples When Compared With a Standard Latex Condom
- ClinicalTrials.gov ID
- NCT04134039
- Acronym / sponsor ID
- 1003201
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- 5 Jul 2021 (actual)
- Study completion
- 5 Jul 2021 (actual)
- First posted
- 21 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This investigation is designed to evaluate the performance rate of a polyurethane (PU) condom versus a standard natural rubber latex (NRL) condom.
Detailed description
In this clinical investigation, a new PU male condom (test condom) will be evaluated against a marketed NRL male condom (reference condom). This clinical investigation will also evaluate the in-use tolerance of the test and reference condoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The condom types will be tested in a 2-way cross-over design where couples will be randomised to use each of the 2 condom types in a defined order, according to the randomisation schedule.
| Arm | Type | Receives |
|---|---|---|
| Polyurethane (PU) condom | Experimental | Device: Polyurethane (PU) condom, Device: Natural Rubber Latex (NRL) condomFollowing randomisation each couple will be given one set of 7 condoms as per randomisation schedule. After use of at least 5 condoms, couples will return to the clinic site for collection of their next set of condoms. Each couple will test a maximum of 14 condoms during their participation in the investigation. |
| Natural Rubber Latex (NRL) condom | Experimental | Device: Polyurethane (PU) condom, Device: Natural Rubber Latex (NRL) condomFollowing randomisation each couple will be given one set of 7 condoms as per randomisation schedule. After use of at least 5 condoms, couples will return to the clinic site for collection of their next set of condoms. Each couple will test a maximum of 14 condoms during their participation in the investigation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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) condomA minimum of 5 condoms (maximum 7 condoms) of each condom type will be provided to couples to be used during vaginal intercourse over a 4 week period, the assessment period. Couples will repeat the assessment period each of the 2 condom types. | Device | Natural Rubber Latex (NRL) condom, Polyurethane (PU) condom |
| Natural Rubber Latex (NRL) condomA minimum of 5 condoms (maximum 7 condoms) of each condom type will be provided to couples to be used during vaginal intercourse over a 4 week period, the assessment period. Couples will repeat the assessment period each of the 2 condom types. | Device | Natural Rubber Latex (NRL) condom, Polyurethane (PU) condom |
Primary outcome
Compared clinical failure rate of condom use between the test condom group and the reference condom group
Time frame: within 2 hours following each coital act for each condom use
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, will be reported by subjects.
6 secondary outcomes
Performance (clinical slippage rate) of the Polyurethane (PU) condom
Time frame: within 2 hours following each coital act for each condom use
Performance (clinical slippage rate) of the Natural Rubber Latex (NRL) condom
Time frame: within 2 hours following each coital act for each condom use
Performance (clinical breakage rate) of the Polyurethane (PU) condom
Time frame: within 2 hours following each coital act for each condom use
Performance (clinical breakage rate) of the Natural Rubber Latex (NRL) condom
Time frame: within 2 hours following each coital act for each condom use
Incidence of treatment-emergent adverse events and adverse device effects, defined in MEDDEV 2.7/3
Time frame: 12 weeks
Subject's experience on the use of each type of condoms [Acceptability and Tolerability
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Unnop Jaisamrarn, MD principal investigator
King Chulalongkorn Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Polyurethane (PU) condom and Natural Rubber Latex (NRL) condom in people with Control of Pregnancy and Prevention of Sexually Transmitted Infections, run by Reckitt Benckiser Healthcare (UK) Limited at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Compared clinical failure rate of condom use between the test condom group and the reference condom group (time frame: within 2 hours following each coital act for each condom use). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.