Original research
Contraceptive effectiveness of a polyurethane condom and a latex condom: A randomized controlled trial

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Abstract

Objective

To compare the contraceptive effectivenesses of a polyurethane condom and a standard latex condom. Secondary outcomes of interest were safety, functionality, discontinuation, and acceptability.

Methods

We randomized 901 couples to use either the polyurethane condom or a standard latex condom as their only form of contraception. We tested for pregnancy at enrollment and at every scheduled follow-up visit (weeks 4, 10, 16, 22, and 30).

Results

The 6-month typical-use pregnancy probabilities were 9.0% (95% confidence interval [CI] 5.9, 12.2) for the polyurethane group and 5.4% (95% CI 2.9, 7.8) for the latex group; the hazard ratio was 1.7 (95% CI 1.1, 2.7), and we failed to reject the null hypothesis of our test of noninferiority. Females in the polyurethane group reported fewer genital irritations (hazard ratio 0.6; 95% CI 0.5, 0.8; P < .01), whereas males in both groups reported the same number of genital irritations (hazard ratio 1.0; 95% CI 0.7, 1.5; P = .94). Total clinical failures (breakage and slippage) were 8.4% for the polyurethane condom and 3.2% for the latex condom (difference 5.3%, 90% CI 2.8, 7.7). The risk of discontinuation did not differ between groups. Participants judged both condoms favorably in terms of the four primary acceptability outcomes (willingness to purchase, willingness to recommend, confidence in method, and general comfort).

Conclusion

The polyurethane condom was not shown to be as effective as the latex comparator condom for pregnancy prevention. However, the risk of pregnancy in the polyurethane group falls in the range of other barrier methods. For people with latex sensitivity or who find latex condoms unacceptable, this polyurethane condom represents one of several synthetic male condom alternatives currently available on the US market.

Section snippets

Materials and methods

We conducted the trial at ten US sites. The ethical review board at Family Health International and the local review boards approved the protocol. All participants provided written informed consent. The study design followed Food and Drug Administration draft guidance recommendations for male condoms made from new materials,9 and we adhered to the CONSORT guidelines in our reporting of results.10

To be eligible, couples had to be 1) 18–35-year-old women and 18–50-year-old men, 2) in good health,

Results

We randomized 901 couples between May 1999 and August 2000, with follow-up completed in April 2001. Of these 901 couples, 878 contributed to the analysis population (range per site, six to 127 couples); we excluded 23 couples because they provided no follow-up data (Figure 3). Baseline characteristics were similar in the two condom groups (Table 1). Loss to follow-up and time contributed by the two groups were similar as well (Table 2). Average coital frequencies per month were similar in the

Discussion

In this trial, the eZ·on condom was not as effective as the latex condom in preventing pregnancy. Although the risk of pregnancy among eZ·on users was higher than that among latex users, the risk was within the range of other barrier contraceptive devices.21

To date, two additional published randomized controlled trials (RCTs) have compared the contraceptive effectiveness of synthetic condoms to that of latex condoms.22, 23 In the first trial with 805 couples,22 the Avanti (London International

References (25)

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    Support for this work was provided with funds from the United States Agency for International Development cooperative agreement no. AID/CCP-3079-A-00-5022-00. The views expressed in this document, however, do not necessarily reflect those of the funding agency. Mayer Laboratories Inc. provided study condoms free of charge. eZ·on is a registered trademark of Mayer Laboratories Inc., which manufactures the product pursuant to a licensing agreement with Family Health International.

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