Levonorgestrel intrauterine system versus oral contraceptives for heavy menses

描述(申请人提供)：月经大出血是女性求医的最常见的妇科问题之一。月经大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旋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极其有限。出血对生活质量的负面影响是女性因月经大出血而寻求治疗的原因，而生活质量是临床医生希望通过治疗月经大出血来改善的结果。还没有临床试验比较左旋诺孕酮宫内系统和联合口服避孕药对自称月经大出血的妇女与出血相关的生活质量、治疗失败的发生率或成本效益的影响。我们的长期目标是开发治疗月经大出血的策略，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。该项目将通过提供关于两种最广泛使用的治疗月经大出血的非手术治疗方法--左旋诺孕酮宫内系统和联合口服避孕药--的重要比较信息，帮助实现这一目标。这项研究的目的是面对面地比较左旋诺孕酮宫内系统和联合口服避孕药对自我报告月经大出血的妇女的月经出血特定生活质量、治疗失败和成本效益的影响。为了达到这项研究的目标，我们将对寻求治疗月经大出血而无子宫结构异常的女性进行一项随机临床试验，比较这两种治疗方案。这项研究的目的是：(1)确定左旋诺孕酮宫内系统和联合口服避孕药在改善与月经出血相关的生活质量方面的相对有效性；(2)比较使用左旋诺孕酮宫内系统和联合口服避孕药的妇女治疗失败(定义为停止治疗和/或请求手术干预)；(3)确定对于有大量月经出血的妇女，左旋诺孕酮宫内系统和联合口服避孕药中哪一种更具成本效益。这项研究意义重大，因为月经大出血是一个重要的妇科问题，对美国相当数量的女性的生活质量产生了不利影响。通过非手术治疗优化月经大出血妇女的生活质量，最终应该会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.