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左炔诺孕酮宫内节育系统的受试者及临床医生经验

Subject and clinician experience with the levonorgestrel-releasing intrauterine system.

作者信息

Jensen Jeffrey T, Nelson Anita L, Costales Antonio C

机构信息

Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland, OR 97239, USA.

出版信息

Contraception. 2008 Jan;77(1):22-9. doi: 10.1016/j.contraception.2007.09.006. Epub 2007 Nov 26.

Abstract

BACKGROUND

Because use of intrauterine contraception is now expanding, this article reports early US clinical experience with the levonorgestrel-releasing intrauterine system (LNG IUS) and assesses subjects' and clinicians' judgment of the adequacy of product information and the overall level of product satisfaction in order to provide insight to new providers of the LNG IUS.

STUDY DESIGN

Multicenter, open-label, uncontrolled, Phase IIIb study. Investigators had no prior experience with the LNG IUS. Subjects and investigators completed surveys and questionnaires at 3, 6 and 12 months.

RESULTS

A total of 509 women, aged 18 to 45 years, were enrolled in this study between July 2000 and June 2002, and 506 (99.4%) received a LNG IUS after the first (488/506, 95.9%) or second (18/20, 90%) insertion attempt. Insertion was rated as "easy" by 91.8% of investigators. Continuation rate at 12 months was 79%. Primary reasons for premature discontinuation were expulsion (4.5%) and menstrual cycle problems (3.8%). Most subjects (84.5%) indicated a high level of satisfaction with the LNG IUS.

CONCLUSION

Over 95% of women had successful insertions of the LNG IUS at first attempt, and less than 1% were unsuccessful after two attempts. Both clinicians and subjects were highly satisfied with product information and their experience with the LNG IUS. One-year continuation rates were comparable to those of other reversible methods.

摘要

背景

由于宫内避孕方法的使用目前正在扩大,本文报告了美国早期使用左炔诺孕酮宫内节育系统(LNG IUS)的临床经验,并评估了受试者和临床医生对产品信息充分性的判断以及产品满意度的总体水平,以便为LNG IUS的新提供者提供参考。

研究设计

多中心、开放标签、非对照的IIIb期研究。研究人员此前没有使用LNG IUS的经验。受试者和研究人员在3个月、6个月和12个月时完成了调查和问卷。

结果

2000年7月至2002年6月期间,共有509名年龄在18至45岁之间的女性参与了本研究,506名(99.4%)在第一次(488/506,95.9%)或第二次(18/20,90%)插入尝试后接受了LNG IUS。91.8%的研究人员将插入过程评为“容易”。12个月时的持续使用率为79%。提前停用的主要原因是节育器脱落(4.5%)和月经周期问题(3.8%)。大多数受试者(84.5%)表示对LNG IUS高度满意。

结论

超过95%的女性首次尝试成功插入LNG IUS,两次尝试后仍不成功的不到1%。临床医生和受试者对产品信息以及他们使用LNG IUS的体验都非常满意。一年持续使用率与其他可逆避孕方法相当。

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