Synthetic Nitrile vs Latex Condoms for STI Prevention

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

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new synthetic nitrile condoms against regular latex ones. Couples will use each type of condom and report their experiences. The goal is to see how well the new condoms work, how safe they are, and if people like them.

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 it safe to use synthetic nitrile condoms for STI prevention?

The safety data available focuses on acrylonitrile, a chemical used in making synthetic materials, and suggests no consistent link to cancer in humans. However, this data is about workers exposed to acrylonitrile, not specifically about using synthetic nitrile condoms. ^{1 2 3 4 5}

How do synthetic nitrile condoms compare to latex condoms for STI prevention?

Synthetic nitrile condoms offer an alternative to latex condoms, potentially increasing user choice and encouraging more consistent condom use. They are made from synthetic materials, which may be more acceptable to some users, and have similar safety and efficacy in preventing sexually transmitted infections. ^{6 7 8 9 10}

What data supports the effectiveness of synthetic nitrile condoms compared to 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 preventing STIs. Additionally, synthetic condoms may offer better safety and acceptability, which could encourage more consistent use. ^{6 7 8 10 11}

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.

My female partner is pregnant or wants to become pregnant during the study.

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. United States pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

Male polyurethane condoms do not enhance brief HIV-STD risk reduction interventions for heterosexually active men: results from a randomized test of concept. [2007]

3. United States pubmed.ncbi.nlm.nih.gov

Comparative evaluation of three Tactylon(TM) condoms and a latex condom during vaginal intercourse: breakage and slippage. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Performance of the Reality polyurethane female condom and a synthetic latex prototype: a randomized crossover trial among South African women. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Condom use rates in a national probability sample of males and females ages 14 to 94 in the United States. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Mortality of United Kingdom acrylonitrile polymerisation workers. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Acrylonitrile and cancer: a review of the epidemiology. [2013]

8. England pubmed.ncbi.nlm.nih.gov

Mortality from tumours in workers in an acrylic fibre factory. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Application of control technology developed in the polyvinyl chloride industry to polymerization processes using acrylonitrile. [2013]

10. United States pubmed.ncbi.nlm.nih.gov

Mortality among rubber workers: VI. Men with potential exposure to acrylonitrile. [2013]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Safety, functionality and acceptability of a prototype polyurethane condom. [2021]