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.

Public Health Relevance

Determining the clinical effectiveness and cost-effectiveness of the two most widely used treatments for heavy menstrual bleeding, the LNG-IUS and COCs, will aid treatment decision making for patients, providers, and the healthcare system. If the clinical effectiveness of both treatments is found to be similar, including cost- effectiveness analyses will help providers and policy makers avoid unnecessary costs to the healthcare system. Optimizing and promoting the use of the most effective non-surgical therapies for women with heavy menstrual bleeding will have a positive impact by decreasing the number of women dissatisfied with the results of non-surgical management who subsequently choose more expensive surgical interventions such as hysterectomy.

National Institute of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Research Project (R01)
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Health Services Organization and Delivery Study Section (HSOD)
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Kaufman, Steven
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Women and Infants Hospital-Rhode Island
United States
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