Original researchContraceptive effectiveness of a polyurethane condom and a latex condom: A randomized controlled trial☆
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 The study design followed Food and Drug Administration draft guidance recommendations for male condoms made from new materials,9 and we adhered to the CONSORT guidelines in our reporting of results.10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
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2023, European Polymer JournalMale and female condoms: Their key role in pregnancy and STI/HIV prevention
2020, Best Practice and Research: Clinical Obstetrics and GynaecologyCitation Excerpt :Natural rubber latex containing natural rubber proteins can induce latex allergies [42]. A small proportion (7%) of the general population may have latex sensitivity with up to a quarter (25%) of health care workers regularly exposed to latex products developing a latex allergy [43]. Although most male and some female condoms are made of natural rubber latex, condoms can be made with synthetic materials including silicone polyisoprene, polyurethane, polyethylene and nitrile (synthetic latex), or natural materials like lamb skin.
Pilot study on functional performance and acceptability of two new synthetic adhesive male condoms (Wondaleaf): a randomized cross-over trial
2019, ContraceptionCitation Excerpt :While some studies [1–4] found that clinical breakage rate of polyurethane SMC is significantly higher than latex external condom, other studies [5–7] found no significant difference between them. Likewise, while some studies found SMC has significantly greater clinical slippage than latex external condom [2–4,7] some did not [1,5,6]. To the best of our knowledge, there are no studies on the functional performance and acceptability of SAMC compared to latex external condoms in the literatures.
Male contraception
2016, Fertility and SterilityCanadian Contraception Consensus Chapter 5 Barrier Methods
2015, Journal of Obstetrics and Gynaecology CanadaCondom type may influence sexual behavior and ejaculation and complicate the assessment of condom functionality
2012, ContraceptionCitation Excerpt :Functionality trials often compare the experimental condom to an established condom using a randomized crossover design, in which each participant uses several condoms of one type followed by several condoms of the other type [3–5]. Condom “effectiveness” trials measure pregnancy or STI outcomes among women using the condoms, typically during 6–12 months of use [6]. Effectiveness trials often employ either a randomized design [6] to compare experimental and established condoms or else a single-arm design [7], in which the observed rate of the outcome for the experimental condom is compared to historical rates from past studies of established condom types.
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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.