Randomized placebo-controlled trial of CDB-2914 in new users of a levonorgestrel-releasing intrauterine system shows only short-lived amelioration of unscheduled bleeding.
Randomized placebo-controlled trial of CDB-2914 in new users of a levonorgestrel-releasing intrauterine system shows only short-lived amelioration of unscheduled bleeding.
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在左炔诺孕酮宫内缓释系统新使用者中进行的 CDB-2914 随机安慰剂对照试验显示，对意外出血的改善仅是短暂的。
DOI：
10.1093/humrep/dep377
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发表时间：
2010
期刊：
影响因子：
--
通讯作者：
Critchley,HOD
中科院分区：
文献类型：
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作者：
Warner,P;Guttinger,A;Glasier,AF;Lee,RJ;Nickerson,S;Brenner,RM;Critchley,HOD
背景左炔诺孕酮宫内缓释系统(LNG-IUS)是一种高效的避孕药。然而，在使用的前几个月，计划外阴道出血很常见，有时会导致停用。本研究旨在确定孕激素受体调节剂CDB-2914在LNG-IUS置入后的前4个月内间歇给药是否能抑制计划外出血。方法从LNG-IUS置入后第21、49和77天开始，连续三天连续三天给药150 mg、分次剂量的CDB-2914 150 mg或安慰剂片。每天的出血日记被完成了6个月，并以出血/斑点出血的天数百分比(BS%)进行汇总。结果69名随机接受CDB-2914治疗的女性和67名安慰剂分别为61和55名完成了试验。安慰剂组BS%随时间延长呈下降趋势(P<；0.0001)，首次治疗后28天−-2914有改善作用(−11%，95%CI为−2)，第三次治疗后转为不利(+10%分，95%CI 1~18分)。结论CDB-2914对BS%的影响最初是有益的，但第三次治疗则不利。然而，只有3%(4/136)的妇女停止了LNG-IUS。这些发现为可能的机制提供了洞察力，并提出了未来的研究方向。ISRCTN58283041；EudraCT No.2006-006511-72。
BACKGROUNDThe levonorgestrel-releasing intrauterine system (LNG-IUS) is a highly effective contraceptive. However, during early months of use unscheduled vaginal bleeding is common, sometimes leading to discontinuation. This study aimed to determine whether intermittent administration of progesterone receptor modulator CDB-2914 would suppress unscheduled bleeding during the first 4 months after insertion of the LNG-IUS.METHODSCDB-2914 150 mg, in divided doses, or placebo tablets, were administered over three consecutive days starting on Days 21, 49 and 77 after LNG-IUS insertion, in a double-blind randomized controlled trial of women aged 19–49 years, newly starting use of LNG-IUS. Daily bleeding diaries were completed for 6 months, and summarized across blocks as percentage days bleeding/spotting (BS%).RESULTSOf 69 women randomized to receive CDB-2914, and 67 placebo, 61 and 55, respectively, completed the trial. BS% decreased with time in both arms, but showed a much steeper treatment-phase gradient in the placebo arm (P< 0.0001), so that a benefit of CDB-2914 in the 28 days after first treatment (−11% points, 95% CI −19 to −2), converted to a disadvantage by 64 days after the third treatment (+10% points, 95% CI 1–18).CONCLUSIONSThe effect of CDB-2914 on BS% was initially beneficial but then by third treatment was disadvantageous. Nevertheless, only 3% (4/136) of all women discontinued LNG-IUS. These findings give insight into possible mechanisms and suggest future research directions.ISRCTN Trial no. ISRCTN58283041; EudraCT no. 2006-006511-72.