Performance of a New CondomNCT05073770
A Clinical Feasibility Study to Assess the Performance of a Latex Condom in Healthy Monogamous Couples.
A study testing Titan Condom in people with Performance of a New Condom, run by Titan Condoms, LLC.
Trial summary
The U.S. Centers for Disease Control and Prevention has recommended the male latex condom as the best physical barrier for preventing HIV and sexually transmitted disease (STD) transmission. Condoms are a safe and effective form of contraception that have 98% effectiveness in protecting against STD and pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Performance of a New Condom
- What is being tested?
- Titan Condom
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Mar 2022
- 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
- Couples not at risk of pregnancy (using alternate contraception).
- Couples who are past or recent/experienced condom users
- No known sexually transmitted infections, including HIV/AIDS, gonorrhea, chlamydia, etc.
- Subjects between 18 to 45 years of age.
- Monogamous heterosexual couples who agree to practice vaginal sex only during the study.
- The Titan Size Guide will be used to determine subject eligibility based on the following penis girth measurements
- Penis girth N64 ≥ 5.8"
- Penis girth N69 ≥ 6.1"
Who cannot join
- Couples who work for the clinical testing laboratory or who are relatives of staff of the clinical test laboratory or a sponsor of the study.
- Participants with known allergy to natural rubber latex or material(s) of test condom.
- Participants with known sensitivity to the residual chemicals used in the manufacturing of natural rubber latex condoms.
- Couples where one knowingly has a sexually transmitted infection.
- Male partners have known erectile or ejaculatory dysfunction.
- Commercial sex workers.
- Female partner is pregnant or desires to become so while participating in the study.
Trial locations and contacts
No sites are listed yet.
About this study
The U.S. Centers for Disease Control and Prevention has recommended the male latex condom as the best physical barrier for preventing HIV and sexually transmitted disease (STD) transmission. Condoms are a safe and effective form of contraception that have 98% effectiveness in protecting against STD and pregnancy. However, evidence shows that if a condom does not fit properly, its impact can reduce to 85% or less, as it may slip off during sex or during removal of the penis from the vagina or breaks during intercourse.
Condoms need to fit correctly to guard against fluids and exposed skin which could lead to STD contraction or pregnancy. To choose the right size, the girth (the width of an erect penis) is the most important factor, not length. However, most condom companies do not list their nominal width, let alone base their sizes off girth. In addition, most brands usually offer XL as only 56 mm based on a misconception that one size fits all and that "XL" condoms are big enough. But that is far from the truth, and several men complain about the lack of simplicity and intuitiveness when finding a condom that fits them.
To address this gap, after a long two years of development, Titan company was able to engineer four distinct sizes so that each man can easily find the condom he needs. This study aims to obtain a preliminary estimate of slippage and breakage of Titan's new condom (64mm or 69mm) during use.
- Conditions
- Performance of a New Condom
- Being tested
- Titan Condom
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titan CondomDevice
The test condoms have the following specifications throughout the study:
- The plain 64mm condom (i.e., N64): Length 223 ±5mm, width 64±1mm, thickness (single wall) 0.070± 0.005mm, and beading thickness 1.25±0.05mm.
- The plain 69mm condom (i.e., N69): Length 223 ±5mm, Width 69±1mm, Thickness (single wall) 0.070± 0.005mm, Beading thickness 1.25±0.05mm.
| Study group | Role | What they receive |
|---|---|---|
| N64 | Experimental | Based on the penis girth measurements, eligible participants will be assigned to two groups:
Group 1: The couples who will test the 64 mm plain condom (n=25).
The test condom has the following specifications throughout the study:
The plain 64mm condom (i.e., N64): Length 223 ±5mm, width 64±1mm, thickness (single wall) 0.070± 0.005mm, and beading thickness 1.25±0.05mm. Receives: Device: Titan Condom |
| N69 | Experimental | Based on the penis girth measurements, eligible participants will be assigned to two groups:
Group 2: The couples who will test the 69 mm plain condom (n=25).
The test condom has the following specifications throughout the study:
The plain 69mm condom (i.e., N69): Length 223 ±5mm, Width 69±1mm, Thickness (single wall) 0.070± 0.005mm, Beading thickness 1.25±0.05mm. Receives: Device: Titan Condom |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance (clinical slippage rate)
Clinical slippage rate will be 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 occurs 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: two-weeks
Performance (clinical breakage rate)
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: two-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study startOct 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Performance of a New CondomStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Titan Condoms, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- STATCure Consulting Services Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073770
- Sponsor's protocol ID
- 9289
- Status last verified
- Oct 2021
- First submitted
- 28 Sep 2021
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study information may be released to the groups listed below: The study sponsor (or sponsor representatives such as monitors and/or auditors) The U.S. Food and Drug Administration (FDA) Sterling Institutional Review Board (IRB) The Department of Health and Human Service (DHHS) Other government agencies in other countries Other doctors, health care professionals or research staff who are involved in the study The results of the study, including participants' information, may also be presented at meetings or in articles written about the study (publications). If the results of the study are published, the participants' identity will remain confidential.
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Feasibility Study to Assess the Performance of a Latex Condom in Healthy Monogamous Couples.
- ClinicalTrials.gov ID
- NCT05073770
- Acronym / sponsor ID
- 9289
- Conditions
- Performance of a New Condom
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Titan Condoms, LLCIndustry (pharma, biotech, devices)
- Collaborators
- STATCure Consulting Services Inc.
- Study start
- Oct 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 11 Oct 2021 (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.
The U.S. Centers for Disease Control and Prevention has recommended the male latex condom as the best physical barrier for preventing HIV and sexually transmitted disease (STD) transmission. Condoms are a safe and effective form of contraception that have 98% effectiveness in protecting against STD and pregnancy. However, evidence shows that if a condom does not fit properly, its impact can reduce to 85% or less, as it may slip off during sex or during removal of the penis from the vagina or breaks during intercourse.
Condoms need to fit correctly to guard against fluids and exposed skin which could lead to STD contraction or pregnancy. To choose the right size, the girth (the width of an erect penis) is the most important factor, not length. However, most condom companies do not list their nominal width, let alone base their sizes off girth. In addition, most brands usually offer XL as only 56 mm based on a misconception that one size fits all and that "XL" condoms are big enough. But that is far from the truth, and several men complain about the lack of simplicity and intuitiveness when finding a condom that fits them.
To address this gap, after a long two years of development, Titan company was able to engineer four distinct sizes so that each man can easily find the condom he needs. This study aims to obtain a preliminary estimate of slippage and breakage of Titan's new condom (64mm or 69mm) during use.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N64 | Experimental | Device: Titan CondomBased on the penis girth measurements, eligible participants will be assigned to two groups: Group 1: The couples who will test the 64 mm plain condom (n=25). The test condom has the following specifications throughout the study: The plain 64mm condom (i.e., N64): Length 223 ±5mm, width 64±1mm, thickness (single wall) 0.070± 0.005mm, and beading thickness 1.25±0.05mm. |
| N69 | Experimental | Device: Titan CondomBased on the penis girth measurements, eligible participants will be assigned to two groups: Group 2: The couples who will test the 69 mm plain condom (n=25). The test condom has the following specifications throughout the study: The plain 69mm condom (i.e., N69): Length 223 ±5mm, Width 69±1mm, Thickness (single wall) 0.070± 0.005mm, Beading thickness 1.25±0.05mm. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Couples not at risk of pregnancy (using alternate contraception).
- Couples who are past or recent/experienced condom users
- No known sexually transmitted infections, including HIV/AIDS, gonorrhea, chlamydia, etc.
- Subjects between 18 to 45 years of age.
- Monogamous heterosexual couples who agree to practice vaginal sex only during the study.
Key exclusion criteria (7 listed)
- Couples who work for the clinical testing laboratory or who are relatives of staff of the clinical test laboratory or a sponsor of the study.
- Participants with known allergy to natural rubber latex or material(s) of test condom.
- Participants with known sensitivity to the residual chemicals used in the manufacturing of natural rubber latex condoms.
- Couples where one knowingly has a sexually transmitted infection.
- Male partners 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 |
|---|---|---|
| Titan CondomThe test condoms have the following specifications throughout the study: 1. The plain 64mm condom (i.e., N64): Length 223 ±5mm, width 64±1mm, thickness (single wall) 0.070± 0.005mm, and beading thickness 1.25±0.05mm. 2. The plain 69mm condom (i.e., N69): Length 223 ±5mm, Width 69±1mm, Thickness (single wall) 0.070± 0.005mm, Beading thickness 1.25±0.05mm. | Device | N64, N69 |
Primary outcome
Performance (clinical slippage rate)
Time frame: two-weeks
Clinical slippage rate will be 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 occurs 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.
Performance (clinical breakage rate)
Time frame: two-weeks
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The study information may be released to the groups listed below: The study sponsor (or sponsor representatives such as monitors and/or auditors) The U.S. Food and Drug Administration (FDA) Sterling Institutional Review Board (IRB) The Department of Health and Human Service (DHHS) Other government agencies in other countries Other doctors, health care professionals or research staff who are involved in the study The results of the study, including participants' information, may also be presented at meetings or in articles written about the study (publications). If the results of the study are published, the participants' identity will remain confidential.
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.
Questions about this trial
What is this clinical trial studying?
A study testing Titan Condom in people with Performance of a New Condom, run by Titan Condoms, LLC.
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 8 inclusion and 7 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 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Niloofar Taghizadeh, PhD (+1 (825) 525-2881, info@statcureinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance (clinical slippage rate) (time frame: two-weeks). 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 11 Oct 2021.