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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of two new polyurethane condoms compared to a regular latex condom. Researchers aim to determine the frequency of breakage or slippage for each type and assess which condoms couples prefer. They seek healthy couples in a monogamous relationship for at least three months who are willing to use only the trial condoms during the study. As an unphased trial, this study allows couples to contribute to research that could improve sexual health options.

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 prior data suggests that these condoms are safe for use?

Research has shown that polyurethane condoms are generally safe for use. One study found an 8.5% failure rate, including breaking or slipping off during use. Although this rate is higher than the 1.6% failure rate for latex condoms, polyurethane condoms remain effective.

Research also indicates that despite a higher breakage rate, polyurethane condoms still provide good protection. They are designed to help prevent pregnancy and sexually transmitted infections.

Overall, polyurethane condoms are well-tolerated and a good choice for those sensitive to latex. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about polyurethane condoms because they offer a non-latex alternative for birth control, which is ideal for individuals with latex allergies. Unlike traditional latex condoms, polyurethane condoms are thinner, which can enhance sensitivity while still providing effective protection. Additionally, polyurethane is more resistant to temperature and humidity changes, potentially extending the shelf life of these condoms compared to latex options.

What evidence suggests that this trial's condoms could be effective for birth control?

This trial will compare the effectiveness of polyurethane condoms with natural rubber latex (NRL) condoms. Research has shown that polyurethane condoms are slightly more prone to breaking or slipping off than NRL condoms. Specifically, studies found a breakage and slippage rate of 8.5% for polyurethane condoms. Regarding pregnancy prevention, the chance of pregnancy over six menstrual cycles was 2.4% with polyurethane condoms, compared to 1.1% with latex condoms. Despite these differences, both types of condoms effectively prevent pregnancy and provide protection. Polyurethane condoms also serve as a good option for individuals allergic to latex. ^{1 3 4 6 7}

Who Is on the Research Team?

Terri Walsh

Principal Investigator

Essential Access Health

Are You a Good Fit for This Trial?

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

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

Both partners must agree not to use drugs or non-investigational devices that can affect sexual performance

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/10224546/

Evaluation of the efficacy of a polyurethane condom - PubMed Similarly adjusted pregnancy rates during consistent use over 6 completed menstrual cycles were 2.4% for the polyurethane condom and 1.1% for the latex condom.

2. guttmacher.org guttmacher.org/journals/psrh/1999/03/evaluation-efficacy-polyurethane-condom-results-randomized-controlled-clinical

Evaluation of the Efficacy of a Polyurethane Condom Clinical failure rates (including breakage and slippage occurring during either intercourse or withdrawal) were 8.5% for the polyurethane condom ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04622306

NCT04622306 | Evaluation of Polyurethane Male Condoms The clinical study will compare two lubricated polyurethane male condoms of different thickness and different sizes with a marketed lubricated control male ...

4. journals.lww.com journals.lww.com/greenjournal/Fulltext/2003/03000/Contraceptive_Effectiveness_of_a_Polyurethane.21.aspx?generateEpub=Article%7Cgreenjournal:2003:03000:00021%7C%7C

Contraceptive Effectiveness of a Polyurethane Condom ... We decided a priori that time to the first occurrence of genital irritation was the primary safety outcome of interest for both female and male participants.

5. researchgate.net researchgate.net/publication/13073012_Evaluation_of_the_Efficacy_of_a_Polyurethane_Condom_Results_from_a_Randomized_Controlled_Clinical_Trial

(PDF) Evaluation of the Efficacy of a Polyurethane Condom Clinical failure rates (including breakage and slippage occurring during either intercourse or withdrawal) were 8.5% for the polyurethane condom ...

6. clinician.com clinician.com/articles/56222-avanti-similar-efficacy-to-latex-more-breaks

Avanti: Similar efficacy to latex, more breaks The Avanti condom, he says, "has a very good breakage rate compared to latex condoms in general. It's the first of a new generation of condoms. And obviously, ...

7. accessdata.fda.gov accessdata.fda.gov/CDRH510K/K922688.pdf

m. vm. - accessdata.fda.gov This condom is intended to aid in the prevention of pregnancy, and is intended to help prevent the transmission of sexually transmitted ...