9/25/2023 0 Comments Fda approves smaller condoms![]() Bootstrap confidence intervals (CIs) were generated for the overall median values by creating 1000 resampled datasets, obtaining the median value from each of the new datasets and using the 2.5th and 97.5th percentiles of all dataset medians as the upper and lower bounds of the 95% CI. Median values and percentiles were used to describe perceived and threshold condom failure levels for anal sex. Perceived and threshold rates of condom failure were assessed using slider bars ranging from 0% to 100%. Participants were then asked to report perceived failure level (‘How often do you think condoms fail when used for anal sex?’) and threshold failure level (‘At what amount of condom failure would you NOT be willing to use condoms for anal sex?’). If a condom was FDA-approved for anal sex, would you be more likely to use condoms every time you have anal sex?’ and (2) ‘If a condom was labeled by the FDA as ‘more pleasurable’, would you be more likely to use this condom for anal sex?’ Participants were instructed that condoms ‘are considered to fail when they slip or break’. Dichotomous items exploring the potential impact of FDA label indications were: (1) ‘Currently there is no condom that is approved by the FDA for use during anal sex. We developed four survey items to assess whether FDA label indications could affect anticipated condom utilisation, as well as perceived and threshold rates of condom failure. To reduce response burden for AMIS participants, supplemental questions such as the ones used in the present study were provided only to a randomly selected subset of the approximately 10 000 annual AMIS participants. After completing an eligibility screener, participants were consented and asked to complete the survey. ![]() 8 Briefly, participants were recruited primarily through online advertising targeted to MSM. A full overview of the cross-sectional survey methods and study population has been published previously. To provide patient-reported information for condom failure, we documented perceived levels of clinical failure for anal sex.ĭata were collected from September 2015 through April 2016 through the American Men’s Internet Survey (AMIS), an annual Internet survey of MSM in the US. To assess whether a label indication is worthwhile, the survey explored willingness to use condoms under a hypothetical condition of an FDA condom label indication for anal sex. 7 We sought to answer these questions through a brief survey among a national, online sample of MSM. Consumer preferences, such as PRO, are increasingly being used by the FDA to inform regulatory guidelines. There are several relevant questions regarding a potential FDA label indication of condoms for anal sex, including: (1) is a label indication for anal sex worth pursuing and (2) what are the levels of patient-reported outcomes (PRO) that can guide label indication. ![]() Although smaller datasets can be used to establish FDA 510(k) equivalence for condoms for vaginal sex, a new label indication for anal sex would likely be a larger undertaking and require a large clinical trial. ![]() 6 Past FDA condom clearance procedures used total clinical failure (slippage and breakage) performance standards from vaginal sex studies, clearing condoms with <5% total clinical failure. The FDA provides guidance for patients in the form of a frequently asked questions section, which includes the hypothetical, ‘Are condoms strong enough for anal intercourse?’ and provides a response of ‘Condoms may be more likely to break during anal intercourse than during other types of sex because of the greater amount of friction and other stresses involved.’ 5įDA guidance for condom studies notes a deficiency of data that could be used for an anal sex label indication, and calls for such data to be made available. Condoms currently on the market in the US and elsewhere have been evaluated and approved based on clinical data from vaginal sex, not anal sex. 1 The US Centers for Disease Control and Prevention and the World Health Organization recommend and promote condom use among MSM, 2, 3 yet condoms are not currently indicated by the US Food and Drug Administration (FDA) for anal sex. Over two of every three new HIV diagnoses in 2015 in the US occurred among men who have sex with men (MSM). ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |