Polyurethane vs Latex Condoms for Birth Control

Recruiting at 2 trial locations

Overseen By Terri Walsh

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Reckitt Benckiser Healthcare (UK) Limited

Must not be taking: Topical genital medications

Disqualifiers: Pregnancy, Fertility treatment, STI protection, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 15 weeks

600 Participants Needed

Trial Summary

What is the purpose of this trial?

This investigation is designed to evaluate the performance rate of two polyurethane male condoms with different sizes and thicknesses versus a standard natural rubber latex (NRL) male condom. The purpose of this study is to see how well the experimental condoms perform compared to the latex rubber condom (for example, how often the different condom types break or slip off the penis). Sponsor also wants to find out how well couples like using the three condom types and whether they experience any problems when using the condoms (for example, irritation or discomfort).

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

The trial protocol does not specify if you need to stop taking your current medications, but it mentions that you cannot use medications that are applied to the genital area or any medication that might interfere with condom use. It's best to discuss your specific medications with the trial investigator.

What data supports the effectiveness of polyurethane and latex condoms for birth control?

Research shows that polyurethane condoms have similar breakage and slippage rates to latex condoms, suggesting they are equally effective for birth control. Additionally, users often prefer polyurethane condoms for their appearance, lack of smell, and comfort, which might encourage more consistent use. ^{1 2 3 4 5}

Are polyurethane condoms safe for use compared to latex condoms?

Polyurethane condoms are generally safe for use and have similar safety profiles to latex condoms. Studies show that they have comparable rates of breakage and slippage, and they are a good alternative for people with latex allergies. ^{1 2 4 5 6}

How do polyurethane condoms differ from latex condoms as a treatment for birth control?

Polyurethane condoms are made from a stronger material than latex, allowing them to be thinner, which can enhance sensation and pleasure. They are also odorless, can be used with oil-based lubricants, and are suitable for people with latex allergies, offering a unique alternative to traditional latex condoms. ^{1 2 4 5 7}

Research Team

Terri Walsh

Principal Investigator

Essential Access Health

Eligibility Criteria

This trial is for healthy monogamous couples who are interested in testing the performance of two different sized polyurethane condoms compared to a standard latex condom. Couples must be willing to use all three types and report on their experiences.

Inclusion Criteria

Both partners participating must provide written informed consent

My partner and I are healthy, in a committed relationship for 3+ months.

Both partners must be able to understand instructions for correct use of condoms

Exclusion Criteria

Either partner is or becomes aware of an allergy or sensitivity to the ingredients of any of the products, including the test or control condoms or any lubrication products provided

Either partner has a pre-existing skin condition as confirmed by the participants

My male partner has had issues with sexual function recently.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use each type of condom (two polyurethane and one latex) to evaluate performance, breakage, slippage, and user acceptability

15 weeks

Multiple visits for each condom type evaluation

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Natural Rubber Latex Condom
• Polyurethane Condom

Trial Overview The study aims to compare the effectiveness and user satisfaction between two sizes of polyurethane condoms and one standard natural rubber latex condom, by assessing rates of breakage, slippage, and any discomfort or problems during use.

Participant Groups

Group I: Polyurethane (PU) male condom-Test condom 2 Experimental Treatment 1 Intervention

Group II: Polyurethane (PU) male condom-Test condom 1 Experimental Treatment 1 Intervention

Group III: Natural Rubber Latex (NRL) male condom- Control condom Active Control 1 Intervention

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?

Reckitt Benckiser Healthcare (UK) Limited

Lead Sponsor

Trials

33

Recruited

5,600+

Novotech (Australia) Pty Limited

Industry Sponsor

Trials

76

Recruited

7,800+

Dr. John Moller

Novotech (Australia) Pty Limited

Chief Executive Officer

MD and MBA from the University of Oxford

Dr. Judith Ng-Cashin

Novotech (Australia) Pty Limited

Chief Medical Officer since 2023

MD

Findings from Research

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 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]

In a study of 901 couples, the polyurethane condom had a higher 6-month pregnancy probability (9.0%) compared to the standard latex condom (5.4%), indicating that the latex condom is more effective for pregnancy prevention.

Despite being less effective, the polyurethane condom caused fewer genital irritations in females and was well-accepted by participants, making it a suitable alternative for those with latex sensitivities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contraceptive effectiveness of a polyurethane condom and a latex condom: a randomized controlled trial. Steiner, MJ., Dominik, R., Rountree, RW., et al.[2019]

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 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 polyurethane eZ.on condom had a higher clinical breakage rate (5.6%) compared to the latex condom (0.9%), indicating it may not be as reliable in preventing breakage during use.

Despite the higher breakage rate, the eZ.on condom showed similar slippage rates to latex condoms and was preferred by nearly 30% of participants, suggesting it could be a viable alternative for those who cannot or choose not to use latex.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized crossover trial comparing the eZ.on plastic condom and a latex condom. Cook, L., Nanda, K., Taylor, D.[2019]

In a study involving 360 couples, the polyurethane condom had a significantly higher breakage rate of 7.2% compared to 1.1% for the latex condom, indicating a higher risk of failure with polyurethane.

Despite the higher breakage rates, nearly half of the users preferred the polyurethane condom for its sensitivity, suggesting it may be a suitable alternative for those who cannot use latex condoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breakage and acceptability of a polyurethane condom: a randomized, controlled study. Frezieres, RG., Walsh, TL., Nelson, AL., et al.[2015]

References

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

Plastic condom available in U.S. [2012]

2. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Contraceptive effectiveness of a polyurethane condom and a latex condom: a randomized controlled trial. [2019]

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

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

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

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

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

Randomized crossover trial comparing the eZ.on plastic condom and a latex condom. [2019]

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

Breakage and acceptability of a polyurethane condom: a randomized, controlled study. [2015]