Polyurethane vs Latex Condoms for Birth Control
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Reckitt Benckiser Healthcare (UK) Limited
Must not be taking: Topical genital medications
Disqualifiers: Pregnancy, Fertility treatment, STI protection, others
No Placebo Group
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.12345
Are polyurethane condoms safe for use compared to latex condoms?
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.12457
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
See 15 more
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.
See 17 more
Trial 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 (Barrier Method)
- Polyurethane Condom (Barrier Method)
Trial OverviewThe 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
3Treatment groups
Experimental Treatment
Active Control
Group I: Polyurethane (PU) male condom-Test condom 2Experimental Treatment1 Intervention
Group II: Polyurethane (PU) male condom-Test condom 1Experimental Treatment1 Intervention
Group III: Natural Rubber Latex (NRL) male condom- Control condomActive Control1 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)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Essential Access Health-BerkeleyBerkeley, CA
Essential Acess Health- SeattleSeattle, WA
Essential Access Health -Los AngelesLos Angeles, CA
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Who Is Running the Clinical Trial?
Reckitt Benckiser Healthcare (UK) Limited
Lead Sponsor
Trials
33
Patients Recruited
5,600+
Novotech (Australia) Pty Limited
Industry Sponsor
Trials
76
Patients Recruited
7,800+
References
Plastic condom available in U.S. [2012]The first polyurethane or "plastic" male condom is on the market. A polyurethane condom called Avanti is for sale in the western United States and should be available throughout the country by summer, according to London International Group plc in Cambridge, England, which developed the condom. Because the plastic material is stronger than latex, the condoms can be made thinner than latex condoms. The thinness of Avanti improves sensation and can heighten pleasure during sexual intercourse, says Dr. Bill Porter, scientific affairs director of London International Group. Unlike latex condoms, plastic condoms have no odor and can be used safely with oil-based lubricants. They can also be used by those who have allergic reactions to latex. The US Food and Drug Administration, a regulatory agency, has required Avanti's labeling to say research has not yet determined its effectiveness in preventing pregnancy or sexually transmitted diseases. The condoms sell for US $1 to $1.50 each, about twice the cost of a latex condom.
Safety, functionality and acceptability of a prototype polyurethane condom. [2021]Male condoms made from synthetic materials offer an alternative to latex condoms that may be more acceptable to users, thereby potentially resulting in more protected acts of intercourse. A prospective, noncomparative clinical study was conducted to evaluate the safety of using certain polyurethane materials to make condoms. Fifty-one healthy, contracepting, mutually monogamous couples were recruited between June 30 and November 24, 1993 to use a prototype roll-on polyurethane condom developed by Family Health International. Couples were to use the condoms for 10 consecutive acts of vaginal intercourse over a 4-week period. Baseline and postexposure genital examinations, including colposcopy for female participants, were performed. Fifty couples completed the study requirements and 517 acts of intercourse occurred using the condoms. Two adverse events were reported: irritation of introitus in a female participant and a small irritated erythematous lesion on a male participant's penis. Neither event was considered to be serious and both were resolved without treatment. Breakage and slippage rates were similar to those reported for latex condoms. These results suggest that polyurethane condoms represent a safe, functional and acceptable alternative to latex condoms.
Contraceptive effectiveness of a polyurethane condom and a latex condom: a randomized controlled trial. [2019]To compare the contraceptive effectivenesses of a polyurethane condom and a standard latex condom. Secondary outcomes of interest were safety, functionality, discontinuation, and acceptability.
Clinical breakage, slippage and acceptability of a new commercial polyurethane condom: a randomized, controlled study. [2019]Although latex remains the primary material for male condoms, a number of condoms made from synthetic materials have appeared in commercial markets in recent years. Published data on the safety and efficacy of these condoms is still limited, but nevertheless synthetic condoms do offer the user a wider choice and may encourage greater use of condoms for contraception and sexual transmitted infection prophylaxis. This paper reports on a study carried out in the Paris region of France on a new, commercial polyurethane condom marketed in Japan as Sagami Original and in Europe as Protex Original. A standard latex condom complying with the European standard for condoms (EN 600:1996) from the same manufacturer was used as the control in the study. The clinical breakage rate for the polyurethane condom was 0.6% (95% confidence interval 0.2-1.4%) compared to 1.3% (95% confidence interval 0.6-2.2%) for the latex condom. The difference was not statistically significant (chi(2) = 1.9, p = 0.168). Clinically significant slippage (complete slippage of the condom off the penis) was 1.1% (95% confidence interval 0.5-1.9%) for the polyurethane condom, compared to 0.5% (95% confidence interval 0.2-1.2%) for the latex; a difference that again was not statistically significant (chi(2) = 1.783, p = 0.182). The polyurethane condom was therefore equivalent to the latex condom in terms of clinical failure rate.
The male polyurethane condom: a review of current knowledge. [2019]Condoms are one of the oldest form of contraceptive and the best recognized form of protection against sexually transmitted diseases. Their use, however, is limited by both behavioral factors and device-related factors, including complaints about decreased sensitivity and sexual enjoyment. To address these limitations, a male condom made of polyurethane was developed. Polyurethane is a strong impermeable material with good heat transfer characteristics that is less susceptible to deterioration during storage than latex. Because little information is available comparing polyurethane and latex condoms in terms of consumer preferences as well as breakage and slippage, we reviewed four pre-marketing studies of polyurethane condoms, one of which included comparison to latex. No significant differences in slippage and breakage rates between latex and polyurethane condoms were reported in the study that included a latex comparator, and other studies of polyurethane condoms alone resulted in rates in the same range as published for latex condoms. Subjectively, consumers expressed significantly greater preference for the polyurethane condom over latex in regard to appearance, lack of smell, likelihood of slippage, comfort, sensitivity, natural look, natural feel, and overall. While additional testing is needed, these preliminary results suggest that the male polyurethane condom reviewed performed at least as well as latex condoms and is preferred by consumers. If preference translates to greater use, the male polyurethane condom may address important barriers that have been linked with inadequate condom use in the past. These results, however, may not be generalizable to other brands of polyurethane condom currently under development.
Randomized crossover trial comparing the eZ.on plastic condom and a latex condom. [2019]This randomized crossover trial compared the breakage and slippage rates, safety, and acceptability of the recently developed polyurethane bi-directional eZ.on condom with a marketed latex condom. Three hundred sixty couples were asked to use 4 eZ.on condoms and 4 latex condoms. Like several other non-latex condoms tested to date, the eZ.on condom had a higher clinical breakage rate than its latex comparator, while the slippage rates were similar. The clinical breakage rate for the eZ.on condom was 5.6%, compared with 0.9% for the latex condom (difference = 4.76%, with upper 95% confidence bound on the difference = 6.26%). Thus, based on an a priori definition of a 2% clinically acceptable difference, the study failed to conclude equivalence relative to clinical breakage. The complete slippage rate for eZ.on was 1.6%; compared to 0.7% for latex (difference = 0.87%, with upper 95% confidence bound = 1.55%). Thus, based on an a priori definition of a 2% difference we concluded equivalence relative to complete slippage. The safety profile of the eZ.on condom was good and similar to the latex condom. The eZ.on was also found to be easier to don and remove than the latex condom. Although no overall preference existed for either condom, nearly 30%women and men strongly preferred the eZ.on condom to the latex condom. The eZ.on condom may be an acceptable alternative for couples unable or unwilling to use latex condoms.
Breakage and acceptability of a polyurethane condom: a randomized, controlled study. [2015]Although the first commercial polyurethane condom was approved for use several years ago, no U.S. clinical trial has compared its performance to that of the latex condom.