What side effects are associated with this type of intervention?

Barrier methods like synthetic nitrile and latex male condoms are generally safe and well-tolerated, with the most common side effects being allergic reactions to the material, such as latex, which can cause itching, redness, and swelling. Topical microbicides, another barrier method, may cause local irritation, burning, or itching at the site of application. These side effects are typically mild and resolve on their own. It is important to note that while these methods are effective in reducing the transmission of STIs, they do not eliminate the risk entirely.

What prior FDA approvals exist?

The FDA has approved various treatments for sexually transmitted infections (STIs), including barrier methods like male condoms. Latex condoms have long been approved and are widely used for preventing STIs, including HIV. Recently, synthetic nitrile male condoms have been evaluated for their functional performance compared to standard latex condoms. Additionally, the FDA has approved several antiviral drugs for treating STIs, such as acyclovir, valacyclovir, and famciclovir for genital herpes, and antibiotics like doxycycline and azithromycin for bacterial infections like chlamydia and syphilis. These treatments, along with barrier methods, form a comprehensive approach to managing and preventing STIs.

What other types of research exist?

Promising novel alternatives to synthetic nitrile male condoms for STI prevention in 2024 include: 1) Nonoxynol-9 vaginal gels, which have shown spermicidal and antimicrobial properties, including activity against HIV and Chlamydia. 2) Iodinated polyvinylpyrrolidone (PVP) formulations combined with nonoxynol-9, which enhance spermicidal efficacy and may offer additional protection against infections. 3) Imiquimod cream, which has been effective in treating genital warts and may offer some protection against HPV. These alternatives should be discussed with a healthcare provider to determine the best option based on individual needs and health status.

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Barrier Method

Synthetic Nitrile vs Latex Condoms for STI Prevention

N/A

Waitlist Available

Led By Mags Beksinska, PhD

Research Sponsored by Karex Industries Sdn. Bhd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 - 5 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include allergic reactions if sensitivity to materials exists (though people with known allergies are excluded), discomfort during use depending on individual fit and preference for material type.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 - 5 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 - 5 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 - 5 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical breakage

Clinical failure

Clinical slippage

Secondary study objectives

Acceptability

Genital discomfort

Non-Clinical breakage

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Synthetic Nitrile Condoms (56mm)

2023

N/A

~600

Synthetic Nitrile Condoms (53mm)

2023

N/A

~600

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Barrier methods, such as condoms, work by physically blocking the exchange of bodily fluids during sexual activity, thereby reducing the transmission of sexually transmitted infections (STIs). This is particularly important for STI patients as it helps prevent the spread of infections like gonorrhea, chlamydia, and HIV. These methods are non-invasive, easy to use, and widely accessible, making them a practical and effective option for many individuals to protect their sexual health.

[New approaches to the combined therapy of gonorrheal infection and accelerated methods for predicting its efficacy].HIV prevention in southern Africa: why we must reassess our strategies?Inhibition of Neisseria gonorrhoeae genital tract infection by leading-candidate topical microbicides in a mouse model.