Synthetic vs Latex Condoms for Condom Use

Recruiting at 1 trial location

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Thai Nippon Rubber Industry Public Company Limited

Must not be taking: Genital condition treatments

Disqualifiers: Pregnancy, STI risk, Latex allergy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 5-7 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of condoms—one made of natural rubber latex and the other of synthetic polyisoprene—to determine which performs better and is more acceptable to users. Researchers aim to compare these condoms in terms of breakage and slippage during use. The trial suits sexually active individuals in a monogamous relationship who use birth control and have no allergies to latex or polyisoprene. Participants must be open to trying both types of condoms and willing to follow specific study guidelines. As an unphased trial, this study allows participants to contribute to important research that could enhance condom options for everyone.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking any medication to treat a genital condition, you may not be eligible to participate.

What prior data suggests that these condoms are safe for use?

Studies have shown that polyisoprene condoms are a safe choice for people with latex allergies. Made from a soft material, they feel natural and comfortable. No reports of serious problems have emerged from their use. Designed to be thin and sensitive, they are popular among users.

Natural rubber latex condoms are widely used and considered safe for most people. They have been the standard option for years without major safety issues. However, some people may be allergic to latex, which can cause itching or a rash.

Both types of condoms in the study are well-liked by users. Polyisoprene condoms are especially suitable for those with latex allergies, while natural rubber latex condoms are a reliable choice for those without such allergies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the comparison between synthetic polyisoprene condoms and natural latex condoms because it could offer more options for those with latex allergies. Unlike latex condoms, which can cause allergic reactions in some users, polyisoprene condoms are made from a synthetic material that mimics the elasticity and strength of latex without triggering allergies. Additionally, both types of condoms in the trial are lubricated with a silicone lubricant, which might enhance comfort and durability. This study could lead to improved condom choices, ensuring safer and more comfortable experiences for users.

What evidence suggests that this trial's treatments could be effective for condom use?

This trial will compare synthetic polyisoprene condoms, such as SKYN condoms, with natural rubber latex condoms. Research has shown that synthetic polyisoprene condoms perform well and feel natural, much like latex condoms. They are 86% to 97% effective at preventing pregnancy and sexually transmitted infections, similar to latex condoms. These condoms offer comfort and sensitivity, making them a popular choice for individuals with latex allergies. Natural rubber latex condoms have a long history of use and are also highly effective. Both types are reliable, but they feel slightly different due to their distinct materials. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals who use condoms and are interested in comparing the performance of a new silicone lubricated synthetic polyisoprene condom to a traditional silicone lubricated natural rubber latex condom. Specific eligibility criteria details were not provided.

Inclusion Criteria

Agree not to use sex toys or drugs intended to enhance or diminish sexual response when using study condoms

Agree to return any unopened condoms

Has home internet access, a valid personal email for each partner, reachable by phone, ability to videoconference and use electronic consent technology

Exclusion Criteria

My female partner is pregnant.

My male partner has had issues with sexual performance recently.

Currently participating in another similar clinical study or employed by a condom manufacturer or Essential Access Health

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use five condoms of each type (polyisoprene and latex) to evaluate slippage, breakage, and acceptability

5-7 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Natural Rubber Latex Condom
• Synthetic Polyisoprene Condom

Trial Overview The study aims to assess the acceptability and functional performance, including breakage and slippage rates, of two types of condoms: one made from synthetic polyisoprene and another from natural rubber latex. Participants will be randomly assigned to use each type in a crossover design.

How Is the Trial Designed?

Group I: polyisoprene condoms lubricated with a silicone lubricant Experimental Treatment 1 Intervention

polyisoprene condoms lubricated with a silicone lubricant

Group II: commercial latex condoms with a silicone lubricant Active Control 1 Intervention

commercial latex condoms with a silicone lubricant

Natural Rubber Latex Condom is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Latex Condom for:

• Prevention of pregnancy
• Prevention of sexually transmitted infections (STIs)

Approved in United States as Latex Condom for:

• Prevention of pregnancy
• Prevention of sexually transmitted infections (STIs)

Approved in Canada as Latex Condom for:

• Prevention of pregnancy
• Prevention of sexually transmitted infections (STIs)

Approved in Japan as Latex Condom for:

• Prevention of pregnancy
• Prevention of sexually transmitted infections (STIs)

Approved in China as Latex Condom for:

• Prevention of pregnancy
• Prevention of sexually transmitted infections (STIs)

Approved in Switzerland as Latex Condom for:

• Prevention of pregnancy
• Prevention of sexually transmitted infections (STIs)

Who Is Running the Clinical Trial?

Thai Nippon Rubber Industry Public Company Limited

Lead Sponsor

Trials

1

Recruited

300+

Published Research Related to This Trial

In a study involving 54 couples, all three types of condoms (natural rubber latex, polyurethane, and a new non-latex SEBS) showed low breakage and slippage rates (≤ 3.3%), indicating they are safe for use during intercourse.

Participants expressed a preference for the natural rubber latex and non-latex SEBS condoms over the polyurethane condom, particularly for ease of use and perceived safety, suggesting that new materials are well-received by consumers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability evaluation of a natural rubber latex, a polyurethane, and a new non-latex condom. Frezieres, RG., Walsh, TL.[2019]

A review of four pre-marketing studies found that polyurethane condoms have similar breakage and slippage rates compared to latex condoms, indicating comparable safety and reliability.

Consumer preferences leaned significantly towards polyurethane condoms over latex, citing advantages in comfort, sensitivity, and overall experience, which could lead to increased usage and better protection against sexually transmitted diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The male polyurethane condom: a review of current knowledge. Rosenberg, MJ., Waugh, MS., Solomon, HM., et al.[2019]

The new polyurethane condom, Avanti, is thinner and stronger than traditional latex condoms, which may enhance sensation and pleasure during use.

While Avanti condoms are safe for those with latex allergies and can be used with oil-based lubricants, the FDA has not yet confirmed their effectiveness in preventing pregnancy or sexually transmitted diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plastic condom available in U.S. [2012]

A new prototype plastic condom is being developed to be as strong as latex, with a lower risk of failure and increased comfort for users, supported by a $1.3 million grant from the National Institutes of Health for testing.

The plastic condom is expected to maintain its strength over time and can be used with any type of lubricant, unlike latex condoms which can lose strength when used with oil-based lubricants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plastic condom developed. [2007]

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]

In a study involving 276 women in Durban, South Africa, both the Reality(R) female condom (FC1) and a new synthetic latex prototype (FC2) were found to have similar levels of acceptability, with over half of participants reporting a good experience with both types.

While some women preferred FC2 slightly more (36.6%) compared to FC1 (29.5%), many participants felt there was little difference between the two, suggesting that women who accept FC1 are likely to accept FC2 as well.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term acceptability of the Reality polyurethane female condom and a synthetic latex prototype: a randomized crossover trial among South African women. Smit, J., Beksinska, M., Vijayakumar, G., et al.[2006]

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]

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. skynfeel.com skynfeel.com/products/skyn-elite-condom?srsltid=AfmBOorymgUq2vTPRyy2SDsaFJfzMdfOdhF35TsqMZWw5AS7mA0eE5E3

SKYN® Elite Condoms for an exceptionally sensitive and ... 15% thinner than our SKYN® Original condoms, these condoms provide ultimate sensitivity. They are also ultra-soft and easily stretch to your shape.

2. amazon.com amazon.com/LifeStyles-SKYN-Elite-Condoms/dp/B0735Q681B

SKYN Elite – 36 Count – Ultra-Thin, Lubricated Latex-Free ... SKYN Premium Polyisoprene Lubricated Condoms easily stretch and conform to your shape so that they are comfortable to use. They're also free from allergens ...

3. skynfeel.com skynfeel.com/products/skyn-original-condom?srsltid=AfmBOoorpqQrAbujv8hq_JTfjUYc-QrCixq5nAOquehw7P34Az81hdNx

SKYN® Original Non-Latex Lubricated condoms provide a ... SKYN® Original Non-Latex Lubricated condoms provide a Natural feeling experience with heightened sensitivity, while being safe and suitable for people with ...

4. verywellhealth.com verywellhealth.com/skyn-non-latex-condoms-906782

SKYN Condoms: A Popular Non-Latex Condom Option Lifestyles assures users that SKYN condoms are as effective as latex condoms. Condom use overall offers an 86% to 97% protection rate, depending ...

5. nytimes.com nytimes.com/wirecutter/reviews/best-condoms/

The Best Condoms for 2025 | Reviews by Wirecutter Made of polyisoprene, a synthetic rubber, the Skyn received the highest sensitivity rating of all the average-size condoms we tested, which ...

6. rbnainfo.com rbnainfo.com/getmsds/84a52b25-42fe-4e3d-a351-75d43c74254a

SAFETY DATA SHEET Wash out mouth with water. Remove victim to fresh air and keep at rest in a position comfortable for breathing.

7. skynfeel.com skynfeel.com/products/skyn-elite-condom?srsltid=AfmBOoqmGuJOvzTzHD8_tuxvFKo1o4OhH4BsuMMtDhIqaP949NEcTC2Z

SKYN® Elite Condoms for an exceptionally sensitive and ... 15% thinner than our SKYN® Original condoms, these condoms provide ultimate sensitivity. They are also ultra-soft and easily stretch to your shape.

8. amazon.com amazon.com/SKYN-Elite-Non-Latex-Lubricated-Condoms/dp/B0973J5YM1

SKYN Elite Ultra Thin Lubricated Non-Latex Condoms, 46 ... Ultra-soft and extra sensitive: This latex-free condom is made from SKYNFEEL technology, a revolutionary polyisoprene material that's so soft and comfortable, ...

9. skynfeel.com skynfeel.com/products/skyn-original-condom?srsltid=AfmBOop1xiTrE5_Cd1K4g0CSvGmdNUPz-Nq7msDX302x8e9kxUoIziEy

SKYN® Original Non-Latex Lubricated condoms provide a ... No latex.​​ SKYN® condoms are made of synthetic polyisoprene, it does not contain natural rubber latex and is a suitable choice for individuals with a known or ...