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首页> 外文期刊>Clinical drug investigation >Bioequivalence and X-ray visibility of a radiopaque etonogestrel implant versus a non-radiopaque implant: A 3-year, randomized, double-blind study
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Bioequivalence and X-ray visibility of a radiopaque etonogestrel implant versus a non-radiopaque implant: A 3-year, randomized, double-blind study

机译：不透射线的依托孕烯植入物与非不透射线的植入物的生物等效性和X射线可见性：一项为期3年的随机双盲研究

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Background: The etonogestrel (ENG)-releasing implant is a subdermal progestogen-only contraceptive that provides coverage for up to 3 years. This long-acting hormonal contraceptive has been available in Europe since 1998 and in the US since 2006. To date, localization of non-palpable implants at insertion and before removal has been dependent on ultrasound or magnetic resonance imaging by an experienced clinician. To facilitate localization in rare cases of non-palpable implants using widely available equipment without the need for a specialist, a radiopaque ENG implant has been developed that is detectable by two-dimensional x-ray imaging. Objective: This study aimed to establish whether the radiopaque ENG implant is bioequivalent in situ compared with the original non-radiopaque ENG implant, and to assess x-ray visibility of the radiopaque ENG implant. Methods: This was a 3-year, randomized, double-blind, parallel-group study carried out in nine international clinical trial centres.Women aged 18-40 years at the time of screening, with menstrual cycles of a usual length of 24-35 days and a body mass index of between ≥18 and ≤29 kg/m 2 were included. Women were assigned to either the radiopaque or non-radiopaque ENG implant in a 1 : 1 ratio via a block randomization by centre. Bioequivalence testing was performed based on the peak ENG concentration (Cmax), and the area under the curve (AUC) for ENG at 6, 24 and 36 months (AUC6mo, AUC24mo and AUC36mo) after insertion. For this purpose, blood sampling for pharmacokinetic determination was performed prior to insertion and for up to 3 years afterwards. Bioequivalence was defined as the 90%confidence interval (CI) of the ratio radiopaque implanton-radiopaque implant of the geometric means (GMR) within the acceptance range of 0.80-1.25. x-Ray visibility was assessed by two-dimensional x-ray imaging after insertion and before removal of the implant. Results: The pharmacokinetic profiles of ENG indicated that the radiopaque and non-radiopaque implants were bioequivalent with respect to the geometric mean of Cmax (GMR 1.06; 90% CI 0.91, 1.23), AUC6mo (GMR 1.00; 90% CI 0.91, 1.10), AUC24mo (GMR 0.98; 90% CI 0.88, 1.10) and AUC36mo (GMR 1.00; 90% CI 0.89, 1.11). The radiopaque ENG implant was clearly visible in 50 out of 52 women after insertion and in all 52 women before removal, whereas none of the non-radiopaque implants were visible. Conclusion: The radiopaque ENG implant is bioequivalent in situ compared with the original non-radiopaque ENG implant and is clearly visible using x-ray imaging.
机译：背景：释放依托孕酮（ENG）的植入物是仅皮下孕激素的避孕药，有效期长达3年。自1998年以来，这种长效激素避孕药已在欧洲上市，自2006年以来，该药已在美国上市。迄今为止，经验丰富的临床医生已将不可触及的植入物定位在插入时和取出前，取决于超声或磁共振成像。为了在不需要专家的情况下使用广泛可用的设备在不触手可及的植入物的罕见情况下进行定位，已开发出可通过二维X射线成像检测到的不透射线ENG植入物。目的：本研究旨在确定不透射线的ENG植入物与原始的不透射线的ENG植入物相比在原位是否具有生物等效性，并评估不透射线的ENG植入物的X射线可见性。方法：这是在9个国际临床试验中心进行的为期3年，随机，双盲，平行分组的研究，筛查时年龄为18-40岁的女性，月经周期通常为24岁35天，体重指数≥18至≤29kg / m 2。通过中心区的随机分组，将女性以不1：1的比例分配给不透射线或不透射线的ENG植入物。根据插入后的ENG峰值浓度（Cmax）和ENG在6、24和36个月时的曲线下面积（AUC）（AUC6mo，AUC24mo和AUC36mo）进行生物等效性测试。为此，在插入之前和之后长达3年的时间里进行血液样本进行药代动力学测定。生物等效性定义为几何平均值（GMR）的不透射线植入物/非不透射线植入物之比在900-1.25的90％置信区间（CI）。在插入后和去除植入物之前，通过二维X射线成像评估X射线可见性。结果：ENG的药代动力学特征表明，不透射线和不透射线的植入物相对于Cmax（GMR 1.06; 90％CI 0.91，1.23），AUC6mo（GMR 1.00; 90％CI 0.91，1.10）的几何平均值具有生物等效性。 ，AUC24mo（GMR 0.98; 90％CI 0.88，1.10）和AUC36mo（GMR 1.00; 90％CI 0.89，1.11）。不透射线的ENG植入物在插入后的52位女性中有50位清晰可见，在切除前的所有52位女性中均清晰可见，而所有非不透射线的植入物均不可见。结论：不透射线的ENG植入物与原始的不透射线的ENG植入物相比在原位具有生物等效性，并且使用X射线成像可以清晰看到。

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