Novel, Non-Hormonal Therapy for the Treatment of Chronic Pain Due to Endometriosis in Adolescent and Adult Women
Abstract
Endometriosis is a gynecologic condition in which tissue similar to the inside lining of the uterus (the endometrium) grows in locations in the body outside of the uterus. This abnormal growth can cause severe pain, often coinciding with a woman’s menstrual period. Endometriosis affects about 10% of all women of reproductive age in the US, and leads to an estimated $22 billion/year in healthcare costs in the US alone. Endometriosis is a chronic disease that can progress over time, leading to infertility, debilitating pelvic pain, and resulting poor quality of life. Disease management involves not only prompt initiation of therapy, but also the maintenance of therapy for a prolonged length of time. As no cure currently exists, the disease typically progresses until menopause. Current medical management typically consists of hormonal medications and surgery, but these therapies are limited by lack of successful relief of symptoms, cost, or side effects. Many patients have endometriosis pain that is refractory to all available treatments. Safe, well-tolerated, long-duration additions to currently available treatments are sorely needed to ameliorate the chronic course of this disease. Angiogenesis refers to the generation of new blood vessels from existing vessels. It is required for the growth of new living tissue and has been implicated in the initiation, maintenance, and spread of endometriosis. We hypothesize that medications that inhibit the process of angiogenesis can be used to treat endometriosis. The angiogenesis inhibitor medications that are currently available cause severe side effects such as birth defects that prevent them from being safely used for treating endometriosis in young, otherwise healthy women. In contrast, there is an alternative medication, cabergoline, which has been extensively used in clinical practice for treatment of other endocrine conditions suffered by reproductive-aged women. While cabergoline appears to inhibit angiogenesis, it acts on this process indirectly such that it has very few side effects, making it appropriate for use in young women with endometriosis. The proposed trial is directly responsive to the current Fiscal Year 2018 Peer Reviewed Medical Research Program Topic Areas of Endometriosis, Chronic Pain Management, and Non-Opioid Pain Management. We directly address the Areas of Encouragement listed in the grant guidelines, including the “development of novel treatments, including non-opioid pain therapies or alternative therapies to alleviate symptoms and reduce secondary effects of endometriosis.” We are investigating a potential novel, non-opioid pain therapy to reduce physical and emotional symptoms of endometriosis. We propose to study cabergoline to treat endometriosis-associated pain, with the goal of alleviating the unmet need for a non-surgical, non-hormonal treatment. We will conduct a clinical drug trial to determine whether cabergoline is an effective addition to standard hormonal therapy for decreasing persistent pelvic pain suffered by adolescents and young women with surgically proven endometriosis. Patients who are interested in participating in our study will be randomized (decided by a flip of a coin) to either receive cabergoline, the investigational medication, or a placebo pill (a sugar pill). We believe that after 6 months, patients who take cabergoline twice a week will demonstrate decreased pain scores and improved quality of life/ability to perform daily activities as compared to patients who take a placebo pill (sugar pill) twice weekly. During the research study, we will study how pain symptoms, menstrual bleeding, levels of inflammation, risk for future cardiac disease, and measures of pain sensitivity change over time by using well-established, validated tools and techniques that our research team have utilized successfully in our previous work. Our study will lead to evidence-based guidelines regarding the safety and effi
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Jul 16, 2019
- Source ID
- W81XWH1910219
Entities
People
- Amy Divasta
Organizations
- United States Army