Evaluation of the efficacy of a nonlatex condom: results from a randomized, controlled clinical trial

CONTEXT : To reduce unintended pregnancy and HIV infection, it is critical to develop reliable male condoms that will attract consumers who reject conventional latex condoms.
METHODS : In a prospective clinical trial conducted in 1998-2000, 830 monogamous couples were randomized in equal numbers to use either a nonlatex condom or a commercial natural latex condom for six months as their only method of birth control. Couples completed detailed reports for the first five condom uses and recorded intercourse and condom use in coital diaries. Pregnancy rates associated with typical and consistent condom use were calculated using life-table analysis. Rates of clinical failure (condom breakage or slippage) were determined for the first five condom uses.
RESULTS : During the first five uses, the nonlatex condom had a higher frequency of breakage or slippage during intercourse or withdrawal (4.0%) than latex condoms (1.3%); the breakage rate for the nonlatex condom was about eight times that of latex condoms. The six-cycle typical-use pregnancy rate did not differ significantly between users of non-latex (10.8%) and latex condoms (6.4%). The six-cycle consistent-use pregnancy rate was higher for nonlatex condom users than for latex condom users (4.9% vs. 1.0%).
CONCLUSIONS : The data present strong indirect support for public health messages that promote the use of latex condoms and, for individuals who cannot or are unwilling to use latex condoms, the use of nonlatex condoms for prevention of pregnancy and disease.     

Does the use of a condom involve a risk for contacting sexually transmitted infections,HIV/AIDS?

The aim of this study is to elucidate and review the risk of sexually transmitted infections (STIs) among condom users. Men and women of reproductive age are the subjects of this study. Data were extracted from the literature through the MEDLINE service for the period 2000–2006. Female condoms (0.1%) were reported to be less liable to break than male condoms (3.1%), while slippage occurs more often with female condoms (5.6%) than with male condoms (1.1%). The nonlatex condoms have a higher frequency of breakage or slippage during intercourse or withdrawal (4%) than latex ones (1.3%). Adolescents having multiple sexual partners and/or having sex with someone they met on that same day are about 80% more likely to report condom failure. Condom breakage or slippage is associated with never having received instructions on correct condom use, more than one sexual partner and more frequent condom use. Ineffective condom use is common among young adults. A younger age, primary partner, lack of partner support, multiple recent sexual partners and use of condoms for contraception are positively associated with delayed condom use. However, condoms do offer 30–90% protection against STIs and HIV passed in the semen and 0–30% protection against diseases due to skin-to-skin contact. This inversely implies that there is always a risk of contacting Chlamydia, gonorrhoea and HIV, or genital herpes and warts even when using a condom during sexual intercourse. Only correct – rather than consistent – condom use reduces the risk of STIs and HIV during intercourse. Therefore, condom users need to be cautioned that some risks are involved with the use of this method.     

Comparative evaluation of three Tactylon(TM) condoms and a latex condom during vaginal intercourse: breakage and slippage

This study compared breakage and slippage rates of three male condom styles made of Tactylon(TM), a synthetic elastomer, to those of a marketed latex condom during vaginal intercourse. Safety and acceptability outcomes were also assessed. This two-center, prospective, crossover study enrolled 443 couples. Each couple was randomly assigned to use three condoms of each type in one of 24 use sequences. Couples completed questionnaires after using each condom, all of one condom type, and all four condom types. The percentage and standard error (SE, in parentheses) of latex condoms with clinical breakage was 0.86% (0.295). Percentages for Tactylon condoms were not equivalent to the latex study condom, ranging from 3.50% to 4.17%. The percentage and SE of latex condoms with complete slippage was 1.11% (0.328). Percentages for Tactylon condoms were equivalent to those for latex, ranging from 0.70% to 1.31%. The Low-Modulus Tactylon condom was the most preferred. Fewer medical events were reported with the Tactylon condoms than with the latex condom. It was concluded that Tactylon condoms were equivalent to the latex condom in terms of slippage but not breakage. However, safety and acceptability seemed to be better for Tactylon condoms. This may improve consistency of use and may attract new users.     

Acceptability evaluation of a natural rubber latex, a polyurethane, and a new non-latex condom

After more than a century of reliance on latex condoms, male condoms fabricated from new materials are finally becoming commercially available to consumers. This study was an open label acceptability study that compared three lubricated condom products during vaginal intercourse: a natural rubber latex condom, a polyurethane condom, and a new non-latex (styrene ethylene butylene styrene, SEBS) condom. Fifty-four couples who were using condoms for birth control were enrolled in this three-way crossover study. Each couple tested three condoms of each type in a randomized sequence. Couples reported condom performance after each use and rated condom acceptability after use of three condoms of each type. At the completion of the study, participants selected their preferred condom type for overall acceptability, sensitivity, ease of use, appearance, and comfort. All three condom types had low clinical breakage and slippage rates (≤ 3.3%) although the polyurethane condom did not perform as well in other measures of performance including unrolling, discomfort, stretching, bunching, and sliding along the penis during intercourse. None of the condom types were statistically preferred overall [males: natural rubber latex 37%, polyurethane 24%, new non-latex (SEBS) 37%, no preference 2%; females: natural rubber latex 33%, polyurethane 27%, new non-latex 37%, no preference 2%]. A statistically higher proportion of couples preferred both the natural rubber latex condom and the new non-latex condom above the polyurethane condom for ease of unrolling, and the natural rubber latex condom above the other condom types for perceived safety. Approximately two-thirds of both male and female participants preferred one of the two condoms made of synthetic materials suggesting that consumers will appreciate the availability of these products.     

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

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.     

Effectiveness of the male latex condom: combined results for three popular condom brands used as controls in randomized clinical trials

BACKGROUND: Although public health programs invest heavily in the male latex condom, its efficacy in preventing pregnancy and sexually transmitted disease has been based primarily on in vitro and retrospective studies. METHODS: We combine the results from two randomized, controlled contraceptive efficacy trials that used commercial latex condoms brands (Ramses Sensitol, LifeStyles, Trojan-Enz) in the control arms. Combining data from the two studies, we obtained longitudinal data covering 3526 menstrual cycles contributed by approximately 800 couples who used latex condoms exclusively for up to six menstrual cycles. Both trials also collected 3715 detailed breakage and slippage reports from the first five study condom uses. The second trial also tested 243 postcoital vaginal samples collected after the first study condom use for the presence of prostate-specific antigen (PSA) and spermatazoa. RESULTS: The combined clinical breakage rate for the first five condom uses was 0.4% for the three latex brands and the combined clinical slippage rate was 1.1%. The combined six-cycle typical-use pregnancy rate for the latex condoms was 7.0% (95% confidence interval 5.0-9.0). The combined six-cycle consistent-use pregnancy rate was 1.0% (95% confidence interval 0.0-2.1). PSA was detected in only 1.2% of postcoital vaginal samples collected after the first use of an intact study condom. There were no differences in performance or efficacy among the three latex brands tested. CONCLUSIONS: The male latex condoms rarely broke or slipped off during intercourse and provided high contraceptive efficacy, especially when used consistently. Risk of semen leakage from intact condoms was very low.     

Condom use among female commercial sex workers in Nevada's legal brothels.

OBJECTIVES. The purpose of this study was to evaluate condom use and the incidence of breakage and slippage during vaginal intercourse among female prostitutes in legal Nevada brothels, where use of condoms is required by law. METHODS. Forty-one licensed prostitutes in three brothels were enrolled in a prospective trial in August 1993. Used condoms were collected to verify reported breaks visually. Retrospective breakage and slippage rates were obtained in a standardized interview. RESULTS. Condoms were used for every act of vaginal intercourse with a brothel client during the study period, as well as in the previous year. In the prospective study phase, condoms were used in 353 acts of vaginal intercourse with clients. No condoms broke, and none fell off the penis during intercourse. Only twice (0.6%) did condoms completely fall off during withdrawal. Twelve times (3.4%) during intercourse and 15 times (4.3%) during withdrawal, condoms slipped down the penis but did not fall off. CONCLUSIONS. These findings, among the lowest breakage and slippage rates published, suggest that regular condom use may lead to condom mastery and the development of techniques to reduce the likelihood of breakage and slippage.     

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

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.     

Nonlatex vs. latex male condoms for contraception: a systematic review of randomized controlled trials

This systematic review sought to evaluate nonlatex male condoms in comparison with latex condoms in terms of contraceptive efficacy, breakage, slippage, safety and user preferences. We searched computerized databases and contacted manufactures and investigators to find randomized controlled trials of nonlatex vs. latex male condoms. Two reviewers independently abstracted data from the 10 identified trials. While the eZ. on condom did not protect against pregnancy as well as its latex comparison condom, no differences were found in typical-use efficacy between the Avanti and the Standard Tactylon and their latex counterparts. Nonlatex condoms were associated with higher rates of clinical breakage than their latex comparisons, with statistically significant odds ratios of clinical breakage ranging from 2.6 (95% confidence interval [CI]: 1.6-4.3) to 5.0 (95% CI: 3.6-6.8). Few adverse events were reported. Substantial proportions of participants reported preferences for the nonlatex condoms. Despite higher rates of clinical breakage, nonlatex condoms still provide an acceptable alternative for those with allergies, sensitivities or preferences that might prevent the consistent use of latex condoms. The contraceptive efficacy of nonlatex condoms requires more research.     

Safety, functionality and acceptability of a prototype polyurethane condom

Male condoms made from synthetic materials offer an alternative to latexcondoms that may be more acceptable to users, thereby potentially resultingin more protected acts of intercourse. A prospective, noncomparativeclinical study was conducted to evaluate the safety of using certainpolyurethane 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 FamilyHealth International. Couples were to use the condoms for 10 consecutiveacts of vaginal intercourse over a 4-week period. Baseline and postexposuregenital examinations, including colposcopy for female participants, wereperformed. Fifty couples completed the study requirements and 517 acts ofintercourse occurred using the condoms. Two adverse events were reported:irritation of introitus in a female participant and a small irritatederythematous lesion on a male participants penis. Neither event wasconsidered to be serious and both were resolved without treatment. Breakageand slippage rates were similar to those reported for latex condoms. Theseresults suggest that polyurethane condoms represent a safe, functional andacceptable alternative to latex condoms.     

Standardized protocols for condom breakage and slippage trials: a proposal.

In the absence of well-controlled studies on the clinical effectiveness of condoms against pregnancy and sexually transmitted diseases, breakage and slippage data may provide the best indication of the protection offered by condom use. According to the recent literature, condom breakage rates range from 0% to 12%, with many US studies falling in the 2% to 5% range. Few studies have collected slippage data. In addition to discussing methodological issues associated with these studies, we propose a standardized protocol for future condom breakage and slippage trials and discuss how results may be used to estimate perfect-use and typical-use pregnancy rates.     

Practice makes perfect: reduction in female condom failures and user problems with short-term experience in a randomized trial

BackgroundFemale condom (FC) failure (breakage, slippage, invagination and misdirection) declines with user experience. Participants in FC performance trials are commonly novice users, and failure rates may be inflated related to inexperience.Study DesignThis was a randomized, crossover study assessing preference, safety, acceptability and function of three new FCs (WC, FC2 and V-Amour) among 170 women in Durban, South Africa. FC failure by condom type use period was investigated in women using five FCs of each type.ResultsOf the 2411 condoms used during intercourse, 96 failures (breakage, slippage, invagination and misdirection) occurred in 86 condoms (77 condoms had one failure, 8 condoms had two failures, and 1 condom had three failures). Total clinical failure was comparable across FC types. The number of failures in the first condom use period was 58 (7.0%), and this decreased to 21 events (2.6%) in the second and, finally, 17 (2.1%) in the last condom use period. No failures were reported in the last use of the FC in the final condom use period.ConclusionsFC failure rates decreased markedly after use of the first five condoms, regardless of FC type, and stabilized in the second and third use periods. Consideration should be given to the number of condoms used in trials to ensure that failure rates are not inflated by limiting the numbers of condoms used by novice users.     

Condom breakage and slippage during heterosexual intercourse: a French national survey. French National Survey on Sexual Behavior Group (ACSF).

OBJECTIVES: This study examined condom failure rates in a representative sample of French men and women. METHODS: Condom users who experienced breakage or slippage were compared with those who reported no difficulties. RESULTS: The rate of breakage at last heterosexual intercourse was 3.4%, and the slippage rate was 1.1%. Significantly associated with breakage and slippage were being age 25 through 34, being sexually active for more than 5 years, condom use for less than 5 years, condom not used for contraception, and sexual intercourse 12 or more times per month. CONCLUSIONS: People who became sexually active before the era of acquired immunodeficiency syndrome, who began condom use in recent years, and who have frequent sex are at increased risk. The low risk observed among experienced condom users below age 25 supports condom promotion to youth.     

The female condom: the African perspective

The female condom is a soft, pliable, prelubricated polyurethane pouch which is inserted into the vagina prior to having sexual intercourse. A flexible polyurethane ring encircles the condom's open end to prevent the entire pouch from entering the vagina during intercourse and to cover the vulva while allowing an entryway for the penis. A smaller flexible ring inside of the condom helps to position and hold the condom within the vagina. Studies have found the female condom to be as effective as male condoms or other female controlled barrier methods in preventing pregnancy. Moreover, the female condom is theoretically better than the male latex condom because of its lower leakage and slippage rates. A recent study in Thailand has shown that accessibility of the female condom can lead to a reduction in STIs among prostitutes, while Trussel et al. estimate that perfect use of the device may reduce the annual risk of acquiring HIV by more than 90% among women who have sexual intercourse twice weekly with an infected male. Women participants in several studies in Africa, however, have complained that the female condom is too long, and over-lubrication has been a reported problem in areas where dry sex is preferred. On the other hand, some users have found sexual intercourse using the female condom to convey the same level of physical sensitivity in the genital region as intercourse without using a barrier method. Evidence suggests that the female condom may be acceptable to men and women in certain types of sexual relationships, but unacceptable in others.     

Identifying condom users at risk for breakage and slippage: findings from three international sites.

OBJECTIVES: This study examined whether past condom failure (breakage, slippage, or both) can predict future failure and evaluated other predictors of condom failure. METHODS: At each of 3 international sites, approximately 130 male condom users were enrolled and given 5 condoms to use for vaginal intercourse over a 3-week period. RESULTS: Men at increased risk (history of 1 or more condoms that broke or slipped off) reported approximately twice as many condom failures as those not in this group. Condom failure increased with the number of adverse condom use behaviors reported per participant. Opening condom packages with sharp objects and unrolling condoms before donning were associated with breakage. Unrolling condoms before donning and lengthy or intense intercourse were associated with slippage. Of background characteristics evaluated, having less education was associated with condom failure. CONCLUSIONS: These data suggest that a history of condom failure predicts future failure, a finding that may be useful for targeted intervention. Moreover, these data provide further evidence that certain behaviors and lower educational attainment are associated with condom failure.     

Condom use and breakage among women in a municipal hospital family planning clinic

For those who choose to be sexually active, condoms are the best available means of protection against sexually transmitted diseases including the human immunodeficiency virus (HIV), which causes acquired immunodeficiency syndrome (AIDS). Condoms are also an effective method for preventing pregnancy. Unfortunately, condoms are not 100% effective at preventing pregnancy or the spread of infection, in part because condoms do break. In order to gain insight into condom breakage, a questionnaire was administered to women attending a municipal hospital family planning clinic. Thirty-six percent of the 106 subjects had experienced at least one condom breakage. Condom breakage occurred in approximately 1 out of 100 acts of intercourse using condoms, with a lifetime breakage rate of 10 per 1000 condom uses and a past year breakage rate of 8 per 1000 condom uses. Breakage rates did not differ substantially by age. Five percent of the women's unplanned pregnancies were attributed to broken condoms. The results of this study corroborate previously reported rates. Factors associated with these women's most recent breakage experiences included: vaginal intercourse, minimal foreplay, and breakage prior to ejaculation. Controlled studies will be needed to determine how the condom can be used to reduce the likelihood of breakage.     

Sex in Australia: experience of condom failure among a representative sample of men

OBJECTIVE: Condom use is a central part of strategies to prevent the transmission of human immunodeficiency virus and other sexually transmissible infections. The objective of this study was to provide reliable estimates of the prevalence and correlates of condom failure among a representative sample of Australian men. METHODS: Computer-assisted telephone interviews were completed by a representative sample of 10,173 men aged 16-59 years from all States and Territories. The response rate was 69.4%. RESULTS: Among men who used condoms in the year prior to being interviewed, 23.8% experienced at least one condom breakage in the past year and 18.1% experienced at least one condom slippage in the past year. Experience of condom breakage in the past year was significantly related to younger age, having a blue-collar occupation, and using more condoms. Neither condom slippage nor condom failure was significantly related to use of water-based lubricants or oil-based lubricants. CONCLUSION: Condom failure is related to certain characteristics of individuals and is not randomly distributed across all condom users. Lubricant use did not affect condom failure. IMPLICATIONS: There may not be a need to promote lubricant use for vaginal intercourse, as there was no association between lubricant use and condom failure.     

How well do male latex condoms work? Pregnancy outcome during one menstrual cycle of use

To evaluate the contraceptive effectiveness of male latex condoms, we assembled a cohort of 300 women relying on male latex condoms for contraception and followed them prospectively for one menstrual cycle. None of the 234 women who completed the study and reported at least one act of intercourse conceived (one cycle pregnancy rate 0%; 95% CI 0%–2%). Given the pattern of intercourse during the cycle and 3 different sets of conception probabilities for different days of the cycle, we would have expected between 32 and 36 pregnancies if no condoms had been used. Thus, the prevented fraction due to condom use (effectiveness) is 100% and the lower bounds of the 95% CI are between 89% and 90%. For this cohort, male latex condoms were an effective method of contraception. This cost-efficient approach of evaluating contraceptive effectiveness shows promise for post-marketing studies.     

Decreased condom breakage and slippage rates after counseling men at a sexually transmitted infection clinic in Jamaica

PURPOSE: Our objective was to evaluate condom failure (breakage and slippage) rates before and those during a trial that provided instructions on correct condom use. METHOD: Our analysis was based on 314 men who presented with urethral discharge at Jamaica's largest sexually transmitted infection clinic and were enrolled into our 6-month trial. RESULTS: Participants reported breaking 18.5% (95% confidence interval=12.8-24.1%) of their condoms during the 7 days prior to the screening visit and having 3.5% (95% confidence interval=1.2-5.7%) of their condoms slip off completely. After the condom counseling provided during the screening visit, breakage rates decreased (p<.05) and remained below 10% throughout the trial. During in-depth interviews, the men who reported frequent condom failures cited (1) improper storage/exposure to heat, (2) improper handling while putting on condoms and (3) use of lubricants/improper lubricants as the possible reasons for their high failure rates. CONCLUSION: Although the rates of reported condom breakage and slippage decreased significantly after counseling, we need to improve the quality of condom counseling to further reduce failure rates.     

Condom performance during vaginal intercourse: comparison of Trojan-Enz and Tactylon condoms.

Forty-nine mutually monogamous couples used a total of 478 condoms during vaginal intercourse in a prospective trial whose purpose was to discover whether the performance of a new non-latex hypoallergenic condom was substantially equivalent to that of a leading condom brand already being marketed. Of these 478 condoms, seven (1.46%) either broke or fell off the penis during intercourse. Two (0.42%) of the 471 condoms that did not break or fall off during intercourse fell off the penis when it was being withdrawn from the vagina. Altogether, 469 (98.1%) of the 478 condoms used for intercourse survived intact throughout intercourse and withdrawal. Differences in breakage and slippage rates for the two condom brands were statistically insignificant. The overall 98.1% success rate is much higher than the rate of success found in a previous condom trial with nearly identical research protocol. The reason for the difference is attributed to much more precise questioning of subjects in the current trial.