Sexually Transmitted DiseasesNCT05912283
Evaluation of 2 Synthetic Nitrile Male Condoms Compared to a Standard Latex Male Condom
A study testing Synthetic Nitrile Condoms (53mm) and Synthetic Nitrile Condoms (56mm) in people with Sexually Transmitted Diseases, run by Karex Industries Sdn. Bhd. at 3 sites in 2 countries.
Trial summary
This is a multi-site, randomised 3-period cross-over trial evaluating the functional performance of two synthetic nitrile male condoms against a control latex male condom. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Diseases
- What is being tested?
- Synthetic Nitrile Condoms (53mm) and Synthetic Nitrile Condoms (56mm)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 2 Jun 2023to 31 Jan 2024
- 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
- Be between the ages of 18 and 45 years (inclusive);
- Be literate (able to read a newspaper or letter easily);
- Have been in an exclusive (monogamous) sexual relationship with partner for at least 3 months; and intend to continue to be an exclusive (monogamous) sexual relationship with their spouse or partner while participating in this research study;
- Be sexually active (defined as having at least one vaginal coital act per week);
- Willing to give informed consent;
- Willing to complete the male condom coital use reports;
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- Willing to use the study condoms as directed;
- Agree to use only the study lubricant provided;
- Agree to only use the study condoms sequentially during time of participation
- Willing to adhere to the follow-up schedule and all study procedures;
- Willing to provide research study staff with an address, phone number or other locator information while participating in the study;
- Willing to participate in the study for the duration of 15 condom uses (approximately 3-5 months);
- Willing to provide photo identification and/or have fingerprint scan to exclude co-enrolment in other research projects;
- Female partner using hormonal or other non-barrier contraception (e.g. OCs, injectable, implant, IUD, or have had a tubal sterilization) or male partner vasectomised;
- Agree to return any unopened condoms;
- Male partner willing to ejaculate during vaginal intercourse;
- Male partner willing to hold on to the condom ring when withdrawing the erect penis after sexual intercourse;
- Agree to not bring study condoms in contact with genital or oral piercing jewelry
- EAH: Both partners have valid personal email and operable mobile phones;
Who cannot join
- Female partner is pregnant or desires to become pregnant during the time of the research study;
- Either partner is known to be HIV positive (based on self report [EAH] or documented HIV-negative test result within past two months [MRU]);
- Self-reported history of recurrent sexually transmitted infection (e.g. gonorrhea, syphilis, Chlamydia);
- Male partner has known erectile or ejaculatory dysfunction;
- Either partner has genital piercing jewelry, uses genital beading or uses sex toys, drugs, medications or non-study devices that can affect sexual performance;
- Either partner has known sensitivities or allergies to latex, synthetic nitrile, vaginal/sexual lubricants or lubricants used on condoms;
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- Either partner reports symptoms of STI (EAH) or has observable evidence of STI as determined through syndromic diagnosis and vaginal/penile examination (MRU);
- Either partner is currently participating in another condom study;
- Either partner is a past or current employee of Essential Access Health, University of the Witwatersrand, or Karex;
- Either partner is a sex worker.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Essential Access Health
Berkeley, California, 94710
Essential Access Health
Los Angeles, California, 90010
About this study
Official title: A Functional Performance and Acceptability Evaluation of 2 Synthetic Nitrile Male Condoms Compared to a Standard Latex Male Condom
This is a multi-site, randomised 3-period cross-over trial evaluating the functional performance of two synthetic nitrile male condoms against a control latex male condom.
Read the detailed description
A sequential randomised 3-period cross-over trial comparing five uses of two synthetic nitrile male condoms of different sizes with a control latex male condom. Each couple will be asked to use five synthetic nitrile condoms (53 mm width), five synthetic nitrile condoms (56 mm width) and five latex male condoms (53 mm width) in a randomised order. Couples will complete a Condom Use Report after each condom use. Function, safety, and acceptability will be assessed at each of three follow-up visits conducted after using each set of five condoms. The trial will enrol 300 couples, anticipating that at least 255 couples will complete the study. Half of the couples (150) will be enrolled in Durban, South Africa and half (150) enrolled in California USA.
- Conditions
- Sexually Transmitted Diseases
- Being tested
- Synthetic Nitrile Condoms (53mm), Synthetic Nitrile Condoms (56mm), Control Latex Condom
- Keywords
- Synthetic Male Condom, Slippage-Breakage Study
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synthetic Nitrile Condoms (53mm)Device
53mm width synthetic nitrile condoms
Synthetic Nitrile Condoms (56mm)Device
56mm width synthetic nitrile condoms
Control Latex CondomDevice
Commercial natural rubber latex condom
| Study group | Role | What they receive |
|---|---|---|
| Synthetic Nitrile Condoms (53mm) | Experimental | 53mm width synthetic nitrile condoms Receives: Device: Synthetic Nitrile Condoms (53mm) |
| Synthetic Nitrile Condoms (56mm) | Experimental | 56mm width synthetic nitrile condoms Receives: Device: Synthetic Nitrile Condoms (56mm) |
| Control Latex Condom | Active comparator | Commercial natural rubber latex condom Receives: Device: Control Latex Condom |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical breakage
Clinical breakage is defined as breakage or tearing during sexual intercourse or during withdrawal of the male condom from the vagina. Clinical breakage is breakage with potential adverse clinical consequences. The clinical breakage rate is calculated by dividing the number of male condoms reported to have broken or torn during sexual intercourse or during withdrawal by the number of male condoms used during vaginal intercourse.
Measured: 3 - 5 months
Clinical slippage
Clinical slippage is defined as a condom slipping completely off the penis during sexual intercourse or during withdrawal from the vagina. The clinical slippage rate is calculated by dividing the number of male condoms that slipped by the number of male condoms used during vaginal intercourse.
Measured: 3 - 5 months
Clinical failure
A Clinical failure is defined as a clinical breakage or a clinical slippage. The clinical failure rate is calculated by dividing the number of male condoms with a clinical failure by the number of male condoms used during vaginal intercourse.
Measured: 3 - 5 months
Secondary outcomes (4)
Genital discomfort
Rates of genital discomfort reported to have occurred during or immediately after condom use. Genital adverse events will be classified by relatedness, expectedness and severity.
Measured: 3 - 5 months
Acceptability
Frequency of key acceptability outcome measures will be calculated and include: comfort in use; ease of insertion and removal; like or dislike of product attributes; adequacy and feel of lubrication and sensitivity and stimulation.
Measured: 3 - 5 months
Non-Clinical breakage
Defined as breakage noticed before sexual intercourse or occurring after withdrawal of the male condom from the vagina. Non-clinical breakage is breakage with no potential adverse clinical consequences. The non-clinical breakage rate is calculated by dividing the number of male condoms reported to have broken before sexual intercourse or after withdrawal by the number of male condom packages opened.
Measured: 3 - 5 months
Non-Clinical slippage
Defined as slippage along the shaft of the penis during sexual intercourse (but not completely off the penis). Non-clinical slippage is slippage with no potential adverse clinical consequences. The non-clinical slippage rate is calculated by dividing the number of male condoms reported to have partially slipped during sexual intercourse by the number of male condoms used during vaginal intercourse.
Measured: 3 - 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start2 Jun 2023
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexually Transmitted DiseasesStudies 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
- A sequential randomised 3-period cross-over trial comparing the functional performance of two synthetic male condoms against a control latex male condom.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karex Industries Sdn. Bhd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Witwatersrand, South Africa, Essential Access Health, Sigma3 Services SARL
- Responsible party
- Sponsor
- Investigators
- Mags Beksinska, PhD, Principal investigator, MatCH Research Unit (MRU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912283
- Sponsor's protocol ID
- Karex02
- Status last verified
- May 2024
- First submitted
- 12 Jun 2023
- Last updated
- 28 May 2024
- Results posted
- 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 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Functional Performance and Acceptability Evaluation of 2 Synthetic Nitrile Male Condoms Compared to a Standard Latex Male Condom
- ClinicalTrials.gov ID
- NCT05912283
- Acronym / sponsor ID
- Karex02
- Conditions
- Sexually Transmitted Diseases
- Keywords
- Synthetic Male Condom, Slippage-Breakage Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Karex Industries Sdn. Bhd.Industry (pharma, biotech, devices)
- Collaborators
- University of Witwatersrand, South Africa, Essential Access Health, Sigma3 Services SARL
- Study start
- 2 Jun 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 22 Jun 2023 (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 is a multi-site, randomised 3-period cross-over trial evaluating the functional performance of two synthetic nitrile male condoms against a control latex male condom.
Detailed description
A sequential randomised 3-period cross-over trial comparing five uses of two synthetic nitrile male condoms of different sizes with a control latex male condom. Each couple will be asked to use five synthetic nitrile condoms (53 mm width), five synthetic nitrile condoms (56 mm width) and five latex male condoms (53 mm width) in a randomised order. Couples will complete a Condom Use Report after each condom use. Function, safety, and acceptability will be assessed at each of three follow-up visits conducted after using each set of five condoms. The trial will enrol 300 couples, anticipating that at least 255 couples will complete the study. Half of the couples (150) will be enrolled in Durban, South Africa and half (150) enrolled in California USA.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A sequential randomised 3-period cross-over trial comparing the functional performance of two synthetic male condoms against a control latex male condom.
| Arm | Type | Receives |
|---|---|---|
| Synthetic Nitrile Condoms (53mm) | Experimental | Device: Synthetic Nitrile Condoms (53mm)53mm width synthetic nitrile condoms |
| Synthetic Nitrile Condoms (56mm) | Experimental | Device: Synthetic Nitrile Condoms (56mm)56mm width synthetic nitrile condoms |
| Control Latex Condom | Active comparator | Device: Control Latex CondomCommercial natural rubber latex condom |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Be between the ages of 18 and 45 years (inclusive);
- Be literate (able to read a newspaper or letter easily);
- Have been in an exclusive (monogamous) sexual relationship with partner for at least 3 months; and intend to continue to be an exclusive (monogamous) sexual relationship with their spouse or partner while participating in this research study;
- Be sexually active (defined as having at least one vaginal coital act per week);
- Willing to give informed consent;
Key exclusion criteria (10 listed)
- Female partner is pregnant or desires to become pregnant during the time of the research study;
- Either partner is known to be HIV positive (based on self report [EAH] or documented HIV-negative test result within past two months [MRU]);
- Self-reported history of recurrent sexually transmitted infection (e.g. gonorrhea, syphilis, Chlamydia);
- Male partner has known erectile or ejaculatory dysfunction;
- Either partner has genital piercing jewelry, uses genital beading or uses sex toys, drugs, medications or non-study devices that can affect sexual performance;
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 |
|---|---|---|
| Synthetic Nitrile Condoms (53mm)53mm width synthetic nitrile condoms | Device | Synthetic Nitrile Condoms (53mm) |
| Synthetic Nitrile Condoms (56mm)56mm width synthetic nitrile condoms | Device | Synthetic Nitrile Condoms (56mm) |
| Control Latex CondomCommercial natural rubber latex condom | Device | Control Latex Condom |
Primary outcome
Clinical breakage
Time frame: 3 - 5 months
Clinical breakage is defined as breakage or tearing during sexual intercourse or during withdrawal of the male condom from the vagina. Clinical breakage is breakage with potential adverse clinical consequences. The clinical breakage rate is calculated by dividing the number of male condoms reported to have broken or torn during sexual intercourse or during withdrawal by the number of male condoms used during vaginal intercourse.
Clinical slippage
Time frame: 3 - 5 months
Clinical slippage is defined as a condom slipping completely off the penis during sexual intercourse or during withdrawal from the vagina. The clinical slippage rate is calculated by dividing the number of male condoms that slipped by the number of male condoms used during vaginal intercourse.
Clinical failure
Time frame: 3 - 5 months
A Clinical failure is defined as a clinical breakage or a clinical slippage. The clinical failure rate is calculated by dividing the number of male condoms with a clinical failure by the number of male condoms used during vaginal intercourse.
4 secondary outcomes
Genital discomfort
Time frame: 3 - 5 months
Acceptability
Time frame: 3 - 5 months
Non-Clinical breakage
Time frame: 3 - 5 months
Non-Clinical slippage
Time frame: 3 - 5 months
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 28 May 2024.
- 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.
Mags Beksinska, PhD principal investigator
MatCH Research Unit (MRU)
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synthetic Nitrile Condoms (53mm) and Synthetic Nitrile Condoms (56mm) in people with Sexually Transmitted Diseases, run by Karex Industries Sdn. Bhd. at 3 sites in 2 countries.
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 19 inclusion and 10 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 28 May 2024. 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, South Africa. 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?
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?
Clinical breakage (time frame: 3 - 5 months). The study lists 3 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 28 May 2024.