Levonorgestrel intrauterine system versus oral contraceptives for heavy menses

描述（由申请人提供）：大量月经出血是女性寻求医疗护理的最常见妇科问题之一。大量月经出血的妇女生活质量下降，并使用昂贵的医疗资源。在美国，复方口服避孕药和左炔诺孕酮宫内系统是两种最常用的非手术治疗大量月经出血的处方。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大量月经出血的原因，而生活质量是临床医生旨在通过治疗大量月经出血来改善的结果。没有临床试验比较左炔诺孕酮宫内节育系统与复方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，或自我报告的月经大量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，最大限度地提高出血相关生活质量的有效性，同时减少手术干预的使用。该项目将通过提供关于两种最广泛使用的治疗大量月经出血的非手术治疗方法（左炔诺孕酮宫内系统和复方口服避孕药）的重要比较信息来帮助实现这一目标。本研究的目的是比较左炔诺孕酮宫内节育系统和复方口服避孕药对自我报告大量月经出血的女性的月经出血特异性生活质量、治疗失败和成本效益的影响。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月经大量出血而无子宫结构异常的妇女中的效果。本研究的目的是：（1）确定左炔诺孕酮宫内系统和复方口服避孕药在改善月经出血相关生活质量方面的相对有效性;（2）比较治疗失败（定义为停止治疗和/或要求手术干预）在接受左炔诺孕酮宫内节育器和复方口服避孕药治疗的妇女之间的差异;（3）确定左炔诺孕酮宫内系统或复方口服避孕药哪种治疗对月经大量出血的妇女更具成本效益。这项研究意义重大，因为大量月经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。通过非手术治疗来优化月经大出血妇女的生活质量，最终应该减少手术干预的次数，降低医疗费用。

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.