Abbott, Abbott Park, IL 60064, USA.
Curr Med Res Opin. 2012 Feb;28(2):291-301. doi: 10.1185/03007995.2011.652732. Epub 2012 Jan 24.
To evaluate secondary exposure of testosterone transferred to females from a male partner, dosed with 1.62% testosterone gel after direct skin-to-skin contact with the application site, and to investigate the effect of wearing a t-shirt on testosterone transfer.
Across three studies, a total of 72 healthy males applied 5.0 g 1.62% testosterone gel to their abdomen alone, upper arms/shoulders alone, or a combination of their upper arms/shoulders and abdomen (single dose or once daily for 7 days). Male-female contact occurred 2 or 12 hours after testosterone gel application, with males either wearing or not wearing a t-shirt. There were 15 minutes of supervised contact with the application site between the male and his female partner. Blood samples were collected over a 24 hour period in females for assessment of serum testosterone levels at baseline and after contact.
Pharmacokinetic parameters included C(max) (maximum serum concentration), AUC(0-24) (area under the serum concentration-time curve from 0-24 hours), and C(av) (time-averaged concentration over the 24-hour period post-contact). Subjects were monitored for adverse events. CLINICAL TRIAL REGISTRATION NCT NUMBERS: Study 1 was not registered (first subject enrolled 8 March 2007); Study 2: 00998933; Study 3, 01130298.
Testosterone levels (C(av) and C(max)) in females increased 86-185% from baseline after direct abdominal skin contact, although C(av) levels remained within female eugonadal range. Testosterone concentrations returned to baseline within 48 hours after last skin contact. A t-shirt barrier reduced testosterone transfer by approximately 40-48% when 5.0 g of testosterone gel was applied to the abdomen alone. A t-shirt barrier prevented transfer when 5.0 g of testosterone gel was applied to the upper arms and shoulders or to a combination of the upper arms and shoulders and the abdomen (C(max) and C(av) increased by approximately 5-11%). No major safety events were observed during the studies.
There is a risk of testosterone transfer from males using 1.62% testosterone gel to others who come in contact with the application site for at least 12 hours after application. Secondary exposure can be mitigated by means of a t-shirt barrier.
Women for these studies were not selected by menopausal status. The study designs were intended to simulate exaggerated conditions of transfer.
评估男性在与应用部位直接皮肤接触后，使用 1.62%睾酮凝胶进行治疗，其伴侣女性从男性身上发生的二次睾酮暴露情况，并研究穿着 t 恤对睾酮转移的影响。
在三项研究中，共有 72 名健康男性单独将 5.0 克 1.62%睾酮凝胶涂于腹部、上臂/肩部或上臂/肩部和腹部（单次剂量或每日一次，共 7 天）。在涂用睾酮凝胶后 2 或 12 小时，男性穿着或不穿着 t 恤与女性发生接触。男性与女性伴侣之间有 15 分钟的监督接触，接触部位是男性的涂药部位。在女性中，在接触后 24 小时内采集血液样本，以评估血清睾酮水平在基线和接触后的变化。
药代动力学参数包括 Cmax（最大血清浓度）、AUC（0-24）（0-24 小时血清浓度时间曲线下面积）和 Cav（接触后 24 小时内的平均浓度）。监测受试者的不良反应。
研究 1 未注册（首位受试者于 2007 年 3 月 8 日入组）；研究 2：00998933；研究 3：01130298。
直接接触腹部皮肤后，女性的睾酮水平（Cav 和 Cmax）从基线升高了 86-185%，尽管 Cav 水平仍在女性正常范围内。末次皮肤接触后 48 小时内，睾酮浓度恢复至基线。当单独应用 5.0 克睾酮凝胶于腹部时，t 恤屏障可减少约 40-48%的睾酮转移。当 5.0 克睾酮凝胶应用于上臂和肩部或上臂和肩部与腹部联合应用时，t 恤屏障可防止睾酮转移（Cmax 和 Cav 增加约 5-11%）。在研究期间未观察到重大安全事件。
男性使用 1.62%睾酮凝胶治疗后，与接触应用部位至少 12 小时后的他人发生睾酮转移的风险存在。通过 t 恤屏障可以减轻二次暴露。
这些研究中的女性不是根据绝经状态选择的。研究设计旨在模拟转移的夸大条件。
