600 Participants Needed

Synthetic Nitrile vs Latex Condoms for STI Prevention

Recruiting at 2 trial locations
MB
TW
Overseen ByTerri Walsh, MPH
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Karex Industries Sdn. Bhd.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

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.12345

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.678910

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.134511

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.

Research Team

MB

Mags Beksinska, PhD

Principal Investigator

MatCH Research Unit (MRU)

Eligibility Criteria

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.
See 15 more

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.
See 7 more

Timeline

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

Treatment Details

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.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Synthetic Nitrile Condoms (56mm)Experimental Treatment1 Intervention
56mm width synthetic nitrile condoms
Group II: Synthetic Nitrile Condoms (53mm)Experimental Treatment1 Intervention
53mm width synthetic nitrile condoms
Group III: Control Latex CondomActive Control1 Intervention
Commercial natural rubber latex condom

Find a Clinic Near You

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+

Findings from Research

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

References

Clinical breakage, slippage and acceptability of a new commercial polyurethane condom: a randomized, controlled study. [2019]
Male polyurethane condoms do not enhance brief HIV-STD risk reduction interventions for heterosexually active men: results from a randomized test of concept. [2007]
Comparative evaluation of three Tactylon(TM) condoms and a latex condom during vaginal intercourse: breakage and slippage. [2019]
Performance of the Reality polyurethane female condom and a synthetic latex prototype: a randomized crossover trial among South African women. [2022]
Condom use rates in a national probability sample of males and females ages 14 to 94 in the United States. [2018]
Mortality of United Kingdom acrylonitrile polymerisation workers. [2019]
Acrylonitrile and cancer: a review of the epidemiology. [2013]
Mortality from tumours in workers in an acrylic fibre factory. [2019]
Application of control technology developed in the polyvinyl chloride industry to polymerization processes using acrylonitrile. [2013]
10.United Statespubmed.ncbi.nlm.nih.gov
Mortality among rubber workers: VI. Men with potential exposure to acrylonitrile. [2013]
Safety, functionality and acceptability of a prototype polyurethane condom. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security