Control of PregnancyPhase 4NCT03739190
A Clinical Investigation to Assess the Performance of Natural Rubber Latex Condoms in Couples
A Phase 4 study testing 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 new 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
- Control of Pregnancy, Prevention of Sexually Transmitted Infections
- What is being tested?
- 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
- 22 Jul 2019to 27 Dec 2019
- 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
Who may be able to join
- 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 use one other 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 e.g. medication/medical devices used to treat erectile dysfunction.
Who cannot join
- Either partner is or becomes aware of an allergy or sensitivity to the ingredients of the test products, including the test or control condoms or any lubrication products provided.
- 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.
- Either partner that 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.
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- 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 participant 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 investigators 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 3-way Cross-over, Multi-centre Clinical Investigation to Evaluate the Performance Rate of Natural Rubber Latex Condoms of Varying Thickness in Healthy Monogamous Couples
This investigation is designed to evaluate the performance rate of a new natural rubber latex (NRL) male condom.
Read the detailed description
In this clinical investigation, a new NRL male condom (test condom) will be evaluated against two marketed NRL male condoms of varying thickness (condom A and condom B). This clinical investigation will also evaluate the in-use tolerance of the test and the two reference condoms.
- Being tested
- NRL Condom
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NRL CondomDevice
A minimum of 5 condoms (maximum 7 condoms) of each condom type will be provided to Subjects to be used during vaginal intercourse over a 4 week period, the assessment period. Couples will repeat the assessment period each of the 3 condom types.
| Study group | Role | What they receive |
|---|---|---|
| Test Condom: Thin NRL Condom | Experimental | Following randomisation each couple will be given one set of 7 condoms as per randomisation schedule. Couples will return to the clinic site for collection of their next set of condoms on two additional occasions. Each couple will test a maximum of 21 condoms during their participation in the investigation. Receives: Device: NRL Condom |
| Reference condom A: Medium Thickness NRL Condom | Active comparator | Not described Receives: Device: NRL Condom |
| Reference condom B: Thick NRL Condom | Active comparator | Not described Receives: Device: 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 A group
Number of clinical failure events, defined in ISO 29943-1:2017, will be reported by participants.
Clinical failure rate is calculated as the number of condoms with at least 1 acute failure event (clinical slippage or clinical breakage) divided by the number of condoms used during intercourse, reported as a percentage. A condom that experiences multiple clinical failure events only counts as a single clinical failure.
Measured: within 2 hours following each coital act for each condom use
Secondary outcomes (4)
Compared clinical failure rate of condom use between the test condom group and the reference condom B group
Number of clinical failure events, defined in ISO 29943-1:2017, will be reported by participants.
Clinical failure rate is calculated as the number of condoms with at least 1 acute failure event (clinical slippage or clinical breakage) divided by the number of condoms used during intercourse, reported as a percentage. A condom that experiences multiple clinical failure events only counts as a single clinical failure.
Measured: within 2 hours following each coital act for each condom use
Compared clinical failure rate of condom use between the test condom group, the reference condom A group and reference condom B group
Number of clinical failure events, defined in ISO 29943-1:2017, will be reported by participants.
Clinical failure rate is calculated as the number of condoms with at least 1 acute failure event (clinical slippage or clinical breakage) divided by the number of condoms used during intercourse, reported as a percentage. A condom that experiences multiple clinical failure events only counts as a single clinical failure.
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: 16 weeks
Subject's experience on the use of each type of condoms [Acceptability and Tolerability]
Acceptability and tolerability as assessed by subject perceived questionnaires
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start22 Jul 2019
- Primary completion27 Dec 2019
- Study completion27 Dec 2019
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The condom types will be tested in a three-way cross-over design where couples will be randomised to use each of the three condom types in a defined order, according to the randomisation schedule.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 470 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03739190
- Sponsor's protocol ID
- 5005901
- Status last verified
- Mar 2020
- First submitted
- 26 Oct 2018
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3-way Cross-over, Multi-centre Clinical Investigation to Evaluate the Performance Rate of Natural Rubber Latex Condoms of Varying Thickness in Healthy Monogamous Couples
- ClinicalTrials.gov ID
- NCT03739190
- Acronym / sponsor ID
- 5005901
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) LimitedIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 27 Dec 2019 (actual)
- Study completion
- 27 Dec 2019 (actual)
- First posted
- 13 Nov 2018 (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 new natural rubber latex (NRL) male condom.
Detailed description
In this clinical investigation, a new NRL male condom (test condom) will be evaluated against two marketed NRL male condoms of varying thickness (condom A and condom B). This clinical investigation will also evaluate the in-use tolerance of the test and the two reference condoms.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The condom types will be tested in a three-way cross-over design where couples will be randomised to use each of the three condom types in a defined order, according to the randomisation schedule.
| Arm | Type | Receives |
|---|---|---|
| Test Condom: Thin NRL Condom | Experimental | Device: NRL CondomFollowing randomisation each couple will be given one set of 7 condoms as per randomisation schedule. Couples will return to the clinic site for collection of their next set of condoms on two additional occasions. Each couple will test a maximum of 21 condoms during their participation in the investigation. |
| Reference condom A: Medium Thickness NRL Condom | Active comparator | Device: NRL Condom |
| Reference condom B: Thick NRL Condom | Active comparator | Device: NRL Condom |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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 use one other 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 e.g. medication/medical devices used to treat erectile dysfunction.
Key exclusion criteria (11 listed)
- Either partner is or becomes aware of an allergy or sensitivity to the ingredients of the test products, including the test or control condoms or any lubrication products provided.
- 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.
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 |
|---|---|---|
| NRL CondomA minimum of 5 condoms (maximum 7 condoms) of each condom type will be provided to Subjects to be used during vaginal intercourse over a 4 week period, the assessment period. Couples will repeat the assessment period each of the 3 condom types. | Device | Reference condom A: Medium Thickness NRL Condom, Reference condom B: Thick NRL Condom, Test Condom: Thin NRL Condom |
Primary outcome
Compared clinical failure rate of condom use between the test condom group and the reference condom A group
Time frame: within 2 hours following each coital act for each condom use
Number of clinical failure events, defined in ISO 29943-1:2017, will be reported by participants. Clinical failure rate is calculated as the number of condoms with at least 1 acute failure event (clinical slippage or clinical breakage) divided by the number of condoms used during intercourse, reported as a percentage. A condom that experiences multiple clinical failure events only counts as a single clinical failure.
4 secondary outcomes
Compared clinical failure rate of condom use between the test condom group and the reference condom B group
Time frame: within 2 hours following each coital act for each condom use
Compared clinical failure rate of condom use between the test condom group, the reference condom A group and reference condom B group
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: 16 weeks
Subject's experience on the use of each type of condoms [Acceptability and Tolerability]
Time frame: 16 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 12 Mar 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 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?
The sponsor lists 5 inclusion and 11 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 12 Mar 2020. 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 A 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 12 Mar 2020.