Condom UseNCT06595836
Evaluation of the Performance and Acceptability of a Synthetic Polyisoprene Male Condom Compared to a Natural Rubber Latex Condom
A study testing Silicone Lubricated Synthetic polyisoprine condom and Silicone Lubricated Natural Rubber Latex Condom in people with Condom Use, run by Thai Nippon Rubber Industry Public Company Limited at 2 sites in United States.
Trial summary
This study is a masked (investigators, research staff), two-way crossover, randomized to sequence of use study designed to evaluate the acceptability and functional performance (breakage, slippage) of a silicone lubricated polyisoprene condom and a silicone lubricated natural rubber latex condom. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Condom Use
- What is being tested?
- Silicone Lubricated Synthetic polyisoprine condom and Silicone Lubricated Natural Rubber Latex Condom
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Jan 2024to 28 Feb 2025
- Phase
- Interventional
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18 and 45 (inclusive)
- Willing and able to give written or electronic informed consent
- Willing to respond to questions concerning their reproductive and contraceptive history and use of condoms contained either on self-administered questionnaires or interviews
- Be sexually active (defined as averaging one vaginal coital act per week)
- Protected against pregnancy by oral contraceptives, an IUD, an implant, contraceptive injections, contraceptive patch, or sterilization (tubal ligation or vasectomy)
- Willing to use the study products for ten acts of vaginal intercourse within six weeks of study entry
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- In a mutually monogamous relationship with their study partner for at least 3 months and be willing to remain mutually monogamous throughout study participation
- Agree not to use any vaginal or sexual lubricant except the product supplied by the study
- Agree not to wear any genital piercing jewelry while using the study condoms
- Agree not to use sex toys or drugs intended to enhance or diminish sexual response when using study condoms
- Agree to return any unopened condoms
- Reachable by telephone
- Has home internet access, a valid personal email for each partner, reachable by phone, ability to videoconference and use electronic consent technology
- Male partner agrees to ejaculate during vaginal intercourse
- Willing to provide photo identification-
Who cannot join
- Currently participating in another similar clinical study or employed by a condom manufacturer or Essential Access Health
- Female partner self-reported as pregnant
- Allergic to natural rubber latex or polyisoprene, or has a history of recurrent adverse events following use of latex or polyisoprene products
- Unable to follow instructions or strictly adhere to the visit schedule
- At significant (high) risk of sexually transmitted infections, including HIV infection, or having a medical history of recurrent, serious sexually transmitted infection (e.g. gonorrhea, syphilis, Chlamydia)
- Currently using condoms for protection against a known sexually transmitted infection
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- Taking any internally applied medication or oral medication to treat a genital condition
- Male partner has had difficulty achieving or maintaining an erection, or achieving ejaculation in the last month under typical circumstances/ conditions.
- Any self-reported genital condition (e.g. itching, burning, irritation, etc.) which, in the opinion of the investigator, could affect use of the study condoms or the ability to interpret study data -
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Essential Access
Berkeley, California, 94710
Terri Walsh, MPH, 213-386-5614, twalsh@essentialacces.com
Terri Walsh, MPH
- Recruiting
Essential Access
Los Angeles, California, 90010-2648
Terri Walsh, MPH, 213-386-5614, twalsh@essentialacces.com
Terri Walsh, MPH
About this study
Official title: Evaluation of the Performance and Acceptability of a Synthetic Polyisoprene Male Condom Compared to a Natural Rubber Latex Condom (Phase II Slippage/Breakage Study)
This study is a masked (investigators, research staff), two-way crossover, randomized to sequence of use study designed to evaluate the acceptability and functional performance (breakage, slippage) of a silicone lubricated polyisoprene condom and a silicone lubricated natural rubber latex condom.
Read the detailed description
Three hundred (300) couples will be enrolled and asked to use five condoms of each of the two types of lubricated condoms to yield a potential sample size of 1500 uses for each type of lubricated condom. To minimize a potential learning effect, couples will be randomly assigned to the sequence of use of each type of lubricated condom.
The primary objective of this study is to examine the slippage, breakage and acceptability of a new polyisoprene male condom compared to a natural rubber latex condom. The study will assess safety in terms of adverse events and user acceptability will be evaluated by comparing physical attributes of the polyisoprene and latex control condoms, as well as perceptions about using the devices.
- Conditions
- Condom Use
- Being tested
- Silicone Lubricated Synthetic polyisoprine condom, Silicone Lubricated Natural Rubber Latex Condom
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silicone Lubricated Synthetic polyisoprine condomDevice
Synthetic polyisoprene condom are made from softer materials for a more natural feel and increased sensitivity
Silicone Lubricated Natural Rubber Latex CondomDevice
Natural rubber latex condoms are made from natural rubber
| Study group | Role | What they receive |
|---|---|---|
| polyisoprene condoms lubricated with a silicone lubricant | Experimental | polyisoprene condoms lubricated with a silicone lubricant Receives: Device: Silicone Lubricated Synthetic polyisoprine condom |
| commercial latex condoms with a silicone lubricant | Active comparator | commercial latex condoms with a silicone lubricant Receives: Device: Silicone Lubricated Natural Rubber Latex Condom |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Clinical Failure
The total clinical failure rate is defined as the number of condoms that broke or slipped completely off the penis during intercourse or withdrawal over the number of condoms used for vaginal intercourse.
Measured: 5 -7 weeks
Secondary outcomes (2)
Clinical Breakage
The clinical breakage rate is defined as the number of condoms that broke during intercourse or withdrawal over the number of condoms used for vaginal intercourse.
Measured: 5 - 7 weeks
Clinical Complete Slippage
The clinical complete slippage rate is defined as the number of condoms that slipped completely off the penis during intercourse or withdrawal over the number of condoms used for vaginal intercourse
Measured: 5-7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start2 Jan 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Condom UseStudies 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
- This study is a masked (investigators, research staff), two-way crossover, randomized to sequence of use study designed to evaluate the acceptability and functional performance (breakage, slippage) of a silicone lubricated polyisoprene condom and a silicone lubricated natural rubber latex condom
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thai Nippon Rubber Industry Public Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595836
- Sponsor's protocol ID
- TNR-01
- Status last verified
- Sep 2024
- First submitted
- 11 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance and Acceptability of a Synthetic Polyisoprene Male Condom Compared to a Natural Rubber Latex Condom (Phase II Slippage/Breakage Study)
- ClinicalTrials.gov ID
- NCT06595836
- Acronym / sponsor ID
- TNR-01
- Conditions
- Condom Use
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Thai Nippon Rubber Industry Public Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 19 Sep 2024 (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 study is a masked (investigators, research staff), two-way crossover, randomized to sequence of use study designed to evaluate the acceptability and functional performance (breakage, slippage) of a silicone lubricated polyisoprene condom and a silicone lubricated natural rubber latex condom.
Detailed description
Three hundred (300) couples will be enrolled and asked to use five condoms of each of the two types of lubricated condoms to yield a potential sample size of 1500 uses for each type of lubricated condom. To minimize a potential learning effect, couples will be randomly assigned to the sequence of use of each type of lubricated condom.
The primary objective of this study is to examine the slippage, breakage and acceptability of a new polyisoprene male condom compared to a natural rubber latex condom. The study will assess safety in terms of adverse events and user acceptability will be evaluated by comparing physical attributes of the polyisoprene and latex control condoms, as well as perceptions about using the devices.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a masked (investigators, research staff), two-way crossover, randomized to sequence of use study designed to evaluate the acceptability and functional performance (breakage, slippage) of a silicone lubricated polyisoprene condom and a silicone lubricated natural rubber latex condom
| Arm | Type | Receives |
|---|---|---|
| polyisoprene condoms lubricated with a silicone lubricant | Experimental | Device: Silicone Lubricated Synthetic polyisoprine condompolyisoprene condoms lubricated with a silicone lubricant |
| commercial latex condoms with a silicone lubricant | Active comparator | Device: Silicone Lubricated Natural Rubber Latex Condomcommercial latex condoms with a silicone lubricant |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Between the ages of 18 and 45 (inclusive)
- Willing and able to give written or electronic informed consent
- Willing to respond to questions concerning their reproductive and contraceptive history and use of condoms contained either on self-administered questionnaires or interviews
- Be sexually active (defined as averaging one vaginal coital act per week)
- Protected against pregnancy by oral contraceptives, an IUD, an implant, contraceptive injections, contraceptive patch, or sterilization (tubal ligation or vasectomy)
Key exclusion criteria (9 listed)
- Currently participating in another similar clinical study or employed by a condom manufacturer or Essential Access Health
- Female partner self-reported as pregnant
- Allergic to natural rubber latex or polyisoprene, or has a history of recurrent adverse events following use of latex or polyisoprene products
- Unable to follow instructions or strictly adhere to the visit schedule
- At significant (high) risk of sexually transmitted infections, including HIV infection, or having a medical history of recurrent, serious sexually transmitted infection (e.g. gonorrhea, syphilis, Chlamydia)
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 |
|---|---|---|
| Silicone Lubricated Synthetic polyisoprine condomSynthetic polyisoprene condom are made from softer materials for a more natural feel and increased sensitivity | Device | polyisoprene condoms lubricated with a silicone lubricant |
| Silicone Lubricated Natural Rubber Latex CondomNatural rubber latex condoms are made from natural rubber | Device | commercial latex condoms with a silicone lubricant |
Primary outcome
Total Clinical Failure
Time frame: 5 -7 weeks
The total clinical failure rate is defined as the number of condoms that broke or slipped completely off the penis during intercourse or withdrawal over the number of condoms used for vaginal intercourse.
2 secondary outcomes
Clinical Breakage
Time frame: 5 - 7 weeks
Clinical Complete Slippage
Time frame: 5-7 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silicone Lubricated Synthetic polyisoprine condom and Silicone Lubricated Natural Rubber Latex Condom in people with Condom Use, run by Thai Nippon Rubber Industry Public Company Limited at 2 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 15 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Clinical Failure (time frame: 5 -7 weeks). 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 19 Sep 2024.