Synthetic Nitrile vs Latex Condoms for STI Prevention

No longer recruiting at 2 trial locations

Overseen By Terri Walsh, MPH

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Karex Industries Sdn. Bhd.

Disqualifiers: Pregnancy, HIV positive, STI history, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 3-5 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare synthetic nitrile condoms to standard latex condoms in preventing sexually transmitted infections (STIs). Participants will use two sizes of synthetic nitrile condoms and a latex condom to determine which is most effective. Eligible participants must be in a monogamous relationship for at least three months, be sexually active, and be willing to use the study condoms and lubricant as instructed. As an unphased trial, this study allows participants to contribute to important research that could enhance sexual health options.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that synthetic nitrile condoms are generally safe and effective. Studies have found that these condoms break and slip at rates similar to latex condoms, making them equally reliable in preventing sexually transmitted infections (STIs).

Information about acrylonitrile, a chemical used in these condoms, suggests no consistent link between this chemical and cancer in humans, indicating a good safety profile.

Overall, synthetic nitrile condoms appear well-tolerated based on available data. They offer a safe alternative to latex condoms, especially for those with latex allergies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about synthetic nitrile condoms because they offer a unique alternative to traditional latex condoms. Unlike latex, nitrile is a synthetic material that can be an excellent option for people with latex allergies. Nitrile condoms are also designed to provide a different fit and feel, with options in both 53mm and 56mm widths, potentially enhancing comfort and satisfaction. This exploration into nitrile condoms could expand choices for consumers and improve overall sexual health by offering effective STI prevention without the risk of latex-induced allergic reactions.

What evidence suggests that this trial's treatments could be effective for STI prevention?

Research has shown that synthetic nitrile condoms, like polyurethane ones, have breakage and slippage rates similar to latex condoms. This similarity indicates they are equally effective in preventing sexually transmitted infections (STIs). Regular condom use can reduce the risk of some infections, such as chlamydia, by about 33%. This trial will compare the effectiveness of synthetic nitrile condoms, available in 53mm and 56mm sizes, with traditional latex condoms. Early results suggest that both sizes of synthetic nitrile condoms are as effective as latex condoms in preventing STIs. ^{1 2 4 6 7}

Who Is on the Research Team?

Mags Beksinska, PhD

Principal Investigator

MatCH Research Unit (MRU)

Are You a Good Fit for This Trial?

Couples aged 18-45, in a monogamous relationship for at least 3 months, who are sexually active and agree to use only study condoms and lubricant. Excludes those with allergies to latex or nitrile, STI symptoms or HIV positive status, pregnant women or those wanting pregnancy soon, participants in other condom studies, employees of the trial's institutions, sex workers, men with sexual dysfunction and individuals with genital piercings.

Inclusion Criteria

Agree to not bring study condoms in contact with genital or oral piercing jewelry

I am sexually active, with at least one sexual encounter per week.

My partner and I both have working email addresses and mobile phones.

Exclusion Criteria

Self-reported history of recurrent sexually transmitted infection

My male partner has known issues with getting or maintaining an erection or with ejaculation.

Either partner is known to be HIV positive

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use five synthetic nitrile condoms (53 mm width), five synthetic nitrile condoms (56 mm width), and five latex male condoms in a randomised order, completing a Condom Use Report after each use.

3-5 months

3 follow-up visits after each set of five condoms

Follow-up

Participants are monitored for functional performance, safety, and acceptability of the condoms used.

3-5 months

What Are the Treatments Tested in This Trial?

Interventions

• Control Latex Condom
• Synthetic Nitrile Condoms (53mm)
• Synthetic Nitrile Condoms (56mm)

Trial Overview The trial is testing two sizes of synthetic nitrile male condoms against a standard latex condom. Participants will use each type over three periods while reporting on their performance during intercourse. The study aims to assess how well these new condoms work compared to the traditional ones.

How Is the Trial Designed?

Group I: Synthetic Nitrile Condoms (56mm) Experimental Treatment 1 Intervention

56mm width synthetic nitrile condoms

Group II: Synthetic Nitrile Condoms (53mm) Experimental Treatment 1 Intervention

53mm width synthetic nitrile condoms

Group III: Control Latex Condom Active Control 1 Intervention

Commercial natural rubber latex condom

Who Is Running the Clinical Trial?

Karex Industries Sdn. Bhd.

Lead Sponsor

Trials

2

Recruited

1,200+

University of Witwatersrand, South Africa

Collaborator

Trials

107

Recruited

10,090,000+

Essential Access Health

Collaborator

Trials

7

Recruited

3,200+

Sigma3 Services SARL

Collaborator

Trials

2

Recruited

1,200+

Published Research Related to This Trial

A study comparing a new polyurethane condom (Sagami Original/Protex Original) to a standard latex condom found that the breakage rates were similar, with 0.6% for polyurethane and 1.3% for latex, indicating that both types are equally reliable in preventing breakage.

The polyurethane condom also showed a slippage rate of 1.1%, compared to 0.5% for latex, but this difference was not statistically significant, suggesting that the polyurethane condom is as effective as latex in terms of preventing slippage during use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical breakage, slippage and acceptability of a new commercial polyurethane condom: a randomized, controlled study. Potter, WD., de Villemeur, M.[2019]

In a study involving 443 couples, Tactylon condoms showed higher breakage rates (3.50% to 4.17%) compared to latex condoms (0.86%), indicating a potential safety concern regarding their durability during use.

Tactylon condoms had slippage rates comparable to latex condoms (0.70% to 1.31%) and were reported to have fewer medical events, suggesting they may be safer and more acceptable, potentially encouraging consistent use among new users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative evaluation of three Tactylon(TM) condoms and a latex condom during vaginal intercourse: breakage and slippage. Callahan, M., Mauck, C., Taylor, D., et al.[2019]

A study involving 51 couples using a prototype polyurethane condom for 10 acts of intercourse over 4 weeks found that the condoms were safe, with only two minor irritation-related adverse events reported, both of which resolved without treatment.

The breakage and slippage rates of the polyurethane condoms were comparable to those of traditional latex condoms, indicating that they are a functional and acceptable alternative for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, functionality and acceptability of a prototype polyurethane condom. Farr, G., Katz, V., Spivey, SK., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04881877?term=graphene&rank=6&checkSpell=

Functional Performance and Acceptability Study of ... The aim of this study is to evaluate the functional performance of two new male condoms compared to a control latex male condom. Couples enrolled in the study ...

2. withpower.com withpower.com/trial/phase-sexually-transmitted-diseases-5-2023-f3b79

Synthetic Nitrile vs Latex Condoms for STI Prevention Research shows that synthetic condoms, like polyurethane, have similar breakage and slippage rates to latex condoms, suggesting they are equally effective in ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05912283/evaluation-of-2-synthetic-nitrile-male-condoms-compared-to-a-standard-latex-male-condom

Evaluation of 2 Synthetic Nitrile Male Condoms Compared ... This is a multi-site, randomised 3-period cross-over trial evaluating the functional performance of two synthetic nitrile male condoms ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4660551/

Condoms: Past, present, and future - PMC [3] A case-control study in STD clinic in Seattle showed 33% risk reduction of chlamydial infections with consistent condom use.

5. clinicaltrial.be clinicaltrial.be/fr/details/284263?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Evaluation of Synthetic Nitrile Male Condom Compared to S... A sequential randomised 2-period cross-over trial comparing five uses of a 61 mm width synthetic nitrile male condom with five uses of a 61 ...

6. ctv.veeva.com ctv.veeva.com/study/evaluation-of-2-synthetic-nitrile-male-condoms-compared-to-a-standard-latex-male-condom

Evaluation of 2 Synthetic Nitrile Male Condoms Compared to ... This is a multi-site, randomised 3-period cross-over trial evaluating the functional performance of two synthetic nitrile male condoms ...

7. ichgcp.net ichgcp.net/clinical-trials-registry/NCT05912283

Evaluation of 2 Synthetic Nitrile Male Condoms ... - ICH GCP 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 ...