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Acceptability of a transdermal gel-based male hormonal contraceptive in a randomized controlled trial

机译:在一项随机对照试验中,基于透皮凝胶的男性荷尔蒙避孕药的可接受性

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Objective Fifty percent of pregnancies in the United States are unintended despite numerous contraceptive methods available to women. The only male contraceptive methods, vasectomy and condoms, are used by 10% and 16% of couples, respectively. Prior studies have shown efficacy of male hormonal contraceptives in development, but few have evaluated patient acceptability and potential use if commercially available. The objective of this study is to determine if a transdermal gel-based male hormonal contraceptive regimen, containing testosterone and Nestorone? gels, would be acceptable to study participants as a primary contraceptive method. Study Design As part of a three-arm, 6-month, double-blind, randomized controlled trial of testosterone and nestorone gels at two academic medical centers, subjects completed a questionnaire to assess the acceptability of the regimen. Of the 99 men randomized, 79 provided data for analysis. Results Overall, 56% (44/79) of men were satisfied or extremely satisfied with this gel-based method of contraception, and 51% (40/79) reported that they would recommend this method to others. One third of subjects (26/79) reported that they would use this as their primary method of contraception if it were commercially available today. However, men with concerns about sexually transmitted disease were significantly less satisfied than men without such concerns (p=0.03). Conclusions A majority of the men who volunteered to participate in this trial of an experimental male hormonal contraceptive were satisfied with this transdermal male hormonal contraceptive. If commercially available, a combination of topical nesterone and testosterone gels could provide a reversible, effective method of contraception that is appealing to men. Implications A substantial portion of men report they would use this transdermal male contraceptive regimen if commercially available. This method would provide a novel, reversible method of contraception for men, whose current choices are limited to condoms and vasectomy.
机译:目的尽管有许多避孕方法可供女性使用,但在美国有百分之五十的怀孕是意外的。仅有10%和16%的夫妻使用唯一的男性避孕方法,输精管结扎术和避孕套。先前的研究表明,男性荷尔蒙避孕药在开发中具有功效,但很少有人评估患者的可接受性和市售潜力。这项研究的目的是确定是否含有睾丸激素和内斯特罗酮的基于透皮凝胶的男性荷尔蒙避孕方案?凝胶,作为主要的避孕方法,对于研究参与者来说是可以接受的。研究设计作为在两个学术医学中心进行的3个月,6个月,双盲,双盲,睾丸激素和Nestorone凝胶随机对照试验的一部分,受试者完成了问卷以评估该方案的可接受性。在随机分配的99位男性中,有79位提供了分析数据。结果总体而言,有56%(44/79)的男性对这种基于凝胶的避孕方法感到满意或非常满意,而51%(40/79)的男性表示他们会推荐这种方法。三分之一的受试者(26/79)报告说,如果今天可以商购,他们将以此为主要避孕方法。但是,对性传播疾病感到担忧的男人比没有这种担忧的男人满意度低得多(p = 0.03)。结论自愿参加该实验性男性荷尔蒙避孕药试验的大多数男性对该透皮男性荷尔蒙避孕药感到满意。如果可商购,局部使用的巢甾酮和睾丸激素凝胶的组合可以提供一种吸引男性的可逆,有效的避孕方法。启示相当一部分男性报告说,如果有商业机会,他们将使用这种经皮男性避孕方案。这种方法将为男性提供一种新颖,可逆的避孕方法,目前的选择仅限于避孕套和输精管切除术。

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