Department of Obstetrics & Gynecology, Keck School of Medicine of the University of Southern California, Los Angeles, CA, USA; The Lundquist Institute at Harbor UCLA Medical Center, Torrance, CA, USA.
Department of Medicine, University of Washington School of Medicine, Seattle, WA, USA.
Contraception. 2020 Jul;102(1):52-57. doi: 10.1016/j.contraception.2020.04.006. Epub 2020 Apr 13.
To determine men's satisfaction with and acceptability of a once-daily, oral regimen of dimethandrolone undecanoate (DMAU) versus placebo when used for 28 days.
After a Phase I double-blind, randomized, placebo-controlled, dose-escalating trial of oral DMAU for 28-days, 57 healthy male volunteers completed a survey assessing their experience and satisfaction with the regimen. In the trial, participants were randomized to receive up to 4 DMAU capsules daily versus placebo and instructed to ingest them within 30 min of consuming a high fat meal. Pharmacokinetic and pharmacodynamic profiles were performed, followed by a 6-week recovery phase. Participants were counseled that they could not rely on the drug for contraception.
Fifty-seven participants were offered acceptability surveys (39 DMAU, 18 placebo). Most respondents, 80% (45/56), reported satisfaction with the method; 77% (44/57) would recommend it. 54% (31/57), reported that, if available, they would use the method as their primary contraceptive. More respondents reported satisfaction with active DMAU than placebo (87% vs. 67%; p = 0.05). Most respondents, 91% (52/57), reported no difficulty with having to take up to 4 pills within 30 min of ingesting a high-fat meal.
Most participants reported that the study method, daily oral DMAU or placebo, was satisfactory and acceptable. Having to take the drug after a high-fat meal did not detract from acceptability.
Most participants in a 4-week trial of daily DMAU capsules would recommend and use the method. High satisfaction among DMAU and placebo groups affirms acceptability of a daily male contraceptive pill, warranting further study of oral DMAU.
确定男性对每日一次口服十一酸双氢睾酮（DMAU）治疗 28 天与安慰剂的满意度和可接受性。
在为期 28 天的口服 DMAU Ⅰ期双盲、随机、安慰剂对照、剂量递增试验后，57 名健康男性志愿者完成了一项评估他们对治疗方案的体验和满意度的调查。在试验中，参与者被随机分配接受高达每日 4 个 DMAU 胶囊与安慰剂治疗，并被指示在进食高脂肪餐 30 分钟内服用。进行了药代动力学和药效学特征分析，随后是 6 周恢复期。参与者被劝告他们不能依赖药物进行避孕。
57 名参与者接受了可接受性调查（39 名 DMAU，18 名安慰剂）。大多数受访者（56 名中的 80%，45 名）对该方法表示满意；77%（57 名中的 44 名）会推荐该方法。54%（57 名中的 31 名）表示，如果有这种方法，他们将把它作为主要的避孕方法。与安慰剂相比，更多的受访者报告对活性 DMAU 感到满意（87%对 67%；p=0.05）。大多数受访者（57 名中的 91%）表示，在进食高脂肪餐 30 分钟内服用多达 4 片药物没有困难。
大多数参与者表示，研究方法，即每日口服 DMAU 或安慰剂，是令人满意和可接受的。必须在进食高脂肪餐后服用药物并不会降低其可接受性。
在为期 4 周的每日 DMAU 胶囊试验中，大多数参与者会推荐并使用该方法。DMAU 和安慰剂组的高满意度证实了每日男性避孕药的可接受性，这进一步证明了口服 DMAU 的研究是合理的。
