Levonorgestrel intrauterine system versus oral contraceptives for heavy menses

描述（由申请人提供）：月经大量出血是妇女求医的最常见妇科问题之一。月经大量出血的妇女生活质量下降，使用昂贵的医疗资源。在美国，联合口服避孕药和左炔诺孕酮宫内系统是治疗月经大出血最常用的两种非手术治疗方法。然而，比较这些治疗方法的研究非常有限。出血对生活质量的负面影响是女性寻求治疗经期大出血的原因，而生活质量是临床医生通过治疗经期大出血来改善的结果。没有临床试验比较左炔诺孕酮宫内系统与联合口服避孕药对出血相关生活质量的影响，治疗失败的发生率，或自我报告大量月经出血的妇女的成本效益。我们的长期目标是制定治疗大量月经出血的策略，最大限度地提高与出血相关的生活质量，同时减少手术干预的使用。本项目将通过提供两种最广泛使用的治疗月经大出血的非手术治疗方法——左炔诺孕酮宫内系统和联合口服避孕药的重要对比信息，协助实现这一目标。本研究的目的是比较左炔诺孕酮宫内系统和联合口服避孕药对月经出血特异性生活质量、治疗失败和自我报告月经大出血妇女的成本效益的直接影响。为了达到本研究的目的，我们将进行一项随机临床试验，比较这两种治疗方案在寻求治疗无子宫结构异常的大量月经出血的妇女中。本研究的目的是：(1)确定左炔诺孕酮宫内系统联合口服避孕药改善月经出血相关生活质量的相对有效性；(2)比较左炔诺孕酮宫内系统和联合口服避孕药治疗失败（定义为停止治疗和/或要求手术干预）的妇女；(3)对于月经大量出血的女性，确定左炔诺孕酮宫内系统或联合口服避孕药哪种治疗更具成本效益。这项研究意义重大，因为月经大量出血是一个重要的妇科问题，对美国大量妇女的生活质量产生不利影响。通过非手术治疗优化重度月经出血妇女的生活质量，最终应减少手术干预的次数并降低医疗保健费用。

DESCRIPTION (provided by applicant): Heavy menstrual bleeding is one of the most common gynecologic problems for which women seek medical care. Women with heavy menstrual bleeding suffer diminished quality of life and utilize expensive medical resources. In the United States, combined oral contraceptives and the levonorgestrel intrauterine system are the two most commonly prescribed non-surgical treatments for heavy menstrual bleeding. However studies comparing these treatments are extremely limited. The negative impact of bleeding on quality of life is why women seek treatment for heavy menstrual bleeding, and quality of life is the outcome clinicians aim to improve by treating heavy menstrual bleeding. No clinical trials have compared the levonorgestrel intrauterine system to combined oral contraceptives in terms of impact on bleeding-related quality of life, incidence of treatment failure, or cost-effectiveness for women with self-reported heavy menstrual bleeding. Our long term goal is to develop strategies for treating heavy menstrual bleeding, which maximize effectiveness in terms of improving bleeding-related quality of life, while decreasing the use of surgical interventions. This project will assist in attaining this goal by providing vital comparatve information on the two most widely used non-surgical treatments for heavy menstrual bleeding, the levonorgestrel intrauterine system and combined oral contraceptives. The objectives of this study are to compare head-to-head the effects of the levonorgestrel intrauterine system and combined oral contraceptives, on menstrual bleeding-specific quality of life, treatment failure, and cost-effectiveness for women who self-report heavy menstrual bleeding. To meet the objectives of this study, we will perform a randomized clinical trial comparing these two treatment options in women seeking treatment for heavy menstrual bleeding without uterine structural abnormalities. The aims of this study are: (1) To determine the relative effectiveness of levonorgestrel intrauterine system and combined oral contraceptives in improving menstrual bleeding-related quality of life; (2) To compare treatment failure (defined as discontinuation of treatment and/or request for surgical intervention) between women treated with levonorgestrel intrauterine system and combined oral contraceptives; (3) To determine which treatment, the levonorgestrel intrauterine system or combined oral contraceptives, is more cost-effective for women with heavy menstrual bleeding. This study is significant because heavy menstrual bleeding is an important gynecologic problem that adversely affects quality of life for a substantial number of women in the United States. Optimizing quality of life in women with heavy menstrual bleeding with non-surgical treatments should ultimately reduce the number of surgical interventions performed and decrease healthcare costs.