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

Trial Summary

What is the purpose of this trial?

This study is a masked (investigators, research staff), two-way crossover, randomized to sequence of use study designed to evaluate the acceptability and functional performance (breakage, slippage) of a silicone lubricated polyisoprene condom and a silicone lubricated natural rubber latex condom.

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 data supports the idea that Synthetic vs Latex Condoms for Condom Use is an effective treatment?

The available research shows that synthetic condoms, like polyurethane and Tactylon, are comparable to latex condoms in terms of effectiveness. For instance, a study found that the clinical breakage rate for a polyurethane condom was 0.6%, which is similar to the 1.3% rate for latex condoms. Another study indicated that Tactylon condoms had similar slippage rates to latex condoms, although they had higher breakage rates. However, Tactylon condoms were preferred for comfort and had fewer medical issues reported, which might encourage more consistent use. Additionally, synthetic condoms can be used by people allergic to latex and with oil-based lubricants, offering more flexibility than latex condoms. ^{1 2 3 4 5}

What safety data exists for synthetic vs latex condoms?

Several studies have evaluated the safety of synthetic condoms compared to latex condoms. A study on polyurethane condoms found no significant difference in breakage and slippage rates compared to latex condoms, suggesting they are equivalent in terms of clinical failure rate. Another study on Tactylon condoms found them equivalent to latex in slippage but not in breakage, although they reported fewer medical events. A prototype polyurethane condom study reported similar breakage and slippage rates to latex, with minor adverse events. Overall, synthetic condoms like polyurethane and Tactylon are considered safe alternatives to latex, with some users preferring them for comfort and acceptability. ^{1 3 5 6 7}

Is the treatment Natural Rubber Latex Condom, Synthetic Polyisoprene Condom a promising treatment?

Yes, synthetic polyisoprene condoms are a promising treatment because they offer more choices for users, can be used by people allergic to latex, and may improve sensation due to their thinness. They are also safe to use with oil-based lubricants and have similar safety and acceptability to latex condoms. ^{1 2 3 6 8}

Eligibility Criteria

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

Willing to provide photo identification

Agree to return any unopened condoms

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

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

Treatment Details

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.

Participant Groups

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+

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.

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]

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]

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]

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 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]

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]

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]

References

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

Plastic condom available in U.S. [2012]

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

Short-term acceptability of the Reality polyurethane female condom and a synthetic latex prototype: a randomized crossover trial among South African women. [2006]

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

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

6. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

The male polyurethane condom: a review of current knowledge. [2019]

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

Plastic condom developed. [2007]