Department of Obstetrics and Gynecology, Linköping University, University Hospital, 58185, Linköping, Sweden.
Department of Clinical and Experimental Medicine, Linköping University, University Hospital, 58185, Linköping, Sweden.
Obes Surg. 2020 Jun;30(6):2217-2224. doi: 10.1007/s11695-020-04447-x.
Women are advised to primarily use non-oral contraceptive alternatives after Roux-en-Y gastric bypass since it is not known if the surgery affects the pharmacokinetics of oral contraceptives.
This is a multi-center, open label, phase 2 pharmacokinetic study performed at the University Hospital of Linköping and the Clinical Trials Center, Department of Obstetrics and Gynecology, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden. Fifteen women aged 18-40 years who had previously undergone Roux-en-Y gastric bypass surgery and reached a BMI < 30 were included. Fifteen BMI-matched women with no previous history of Roux-en-Y gastric bypass surgery served as a control group. After administration of a single dose of a combined oral contraceptive containing 0.03 mg ethinylestradiol/0.15 mg levonorgestrel, serum levonorgestrel concentrations were determined during a 24-h period using ultra performance liquid chromatography/tandem mass spectrometry. The area under the plasma concentration time curve of levonorgestrel (AUC) was the main outcome measure.
There were no significant differences in the studied pharmacokinetic parameters, AUC, total AUC, peak serum concentration (C), time to peak serum concentrations (T), apparent oral clearances of levonorgestrel (CL), or terminal half-lives (t½) between the groups.
This is to our knowledge the first study to evaluate the pharmacokinetics of oral levonorgestrel in women with a BMI < 30 at least 1 year after RYGB compared with a BMI-matched group of women. We could not find any significant pharmacokinetic differences between the groups, suggesting that oral levonorgestrel may be used in non-obese women after Roux-en-Y gastric bypass once a stable body weight has been reached.
EudraCT 2014-004677-17.
由于不清楚手术是否会影响口服避孕药的药代动力学，因此建议女性在接受 Roux-en-Y 胃旁路手术后主要使用非口服避孕药替代方法。
这是一项在瑞典林雪平大学医院和卡罗林斯卡研究所斯德哥尔摩丹德吕德医院妇产科临床试验中心进行的多中心、开放标签、2 期药代动力学研究。该研究纳入了 15 名年龄在 18-40 岁之间、先前接受过 Roux-en-Y 胃旁路手术且 BMI<30 的女性。15 名 BMI 匹配且无 Roux-en-Y 胃旁路手术史的女性作为对照组。在给予含有 0.03 毫克炔雌醇/0.15 毫克左炔诺孕酮的单一剂量复方口服避孕药后，使用超高效液相色谱/串联质谱法在 24 小时内测定左炔诺孕酮的血清浓度。左炔诺孕酮的血浆浓度时间曲线下面积（AUC）是主要观察指标。
两组在研究的药代动力学参数、AUC、总 AUC、峰值血清浓度（C）、达峰时间（T）、左炔诺孕酮的表观口服清除率（CL）或半衰期（t½）方面均无显著差异。
这是我们所知的第一项研究，评估了至少 1 年后 BMI<30 的女性在 RYGB 后与 BMI 匹配的女性组相比，口服左炔诺孕酮的药代动力学。我们没有发现两组之间存在任何显著的药代动力学差异，这表明一旦达到稳定的体重，口服左炔诺孕酮可能可用于 Roux-en-Y 胃旁路手术后的非肥胖女性。
EudraCT 2014-004677-17。
