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A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endometriosis
What is endometriosis?
Endometriosis happens when tissue similar to the lining of the uterus grows outside it, on the ovaries, the fallopian tubes, the bowel, or the bladder. That tissue still reacts to the hormones of the menstrual cycle, so it gets inflamed, it hurts, and over time it can form scar tissue. It's also a leading cause of infertility, though not everyone with endometriosis has trouble conceiving. More than 11 in 100 American women ages 15 to 44 have endometriosis, over 6.5 million people in the US, and about 1 in 10 women of reproductive age worldwide. Most are diagnosed in their 30s and 40s, but symptoms often start much earlier, in the teenage years. Getting an answer takes a long time: the average delay from first symptoms to a confirmed diagnosis runs 4 to 11 years.
Research in this field is still catching up. About seven drugs carry an FDA approval specifically for endometriosis, and the first modern oral option, Orilissa, only arrived in 2018. Endometriosis is also linked to higher rates of IBS, fibromyalgia, and chronic fatigue syndrome, conditions researchers are still working out the connection to. Studies here are also harder to run than most, because pain rises and falls with the cycle and many participants feel better on placebo too.
Can endometriosis be cured?
No. Doctors can treat endometriosis but they cannot get rid of it, and the Global health guidelines are blunt about this: care aims to control symptoms, not to end the disease. Surgery removes the tissue, but it can grow back. The drugs on the market quiet the cycle rather than fix what causes the growths in the first place.
Endometriosis clinical trial types
Researchers use several types of clinical trials to investigate and manage endometriosis. Each type focuses on different aspects of the condition, including treatment, diagnosis, and understanding disease mechanisms.
Genetic and biomarker studies
The purpose of genetic and biomarker studies in endometriosis is to explore the underlying biological factors that may predispose individuals to develop the condition, determine the severity of the disease, or predict responses to specific treatments. These studies focus on identifying genetic variations, such as specific gene mutations or polymorphisms, that may increase the risk of endometriosis, thereby helping to uncover the hereditary aspects of the disease.
Researchers aim to discover biomarkers - measurable indicators such as proteins, hormones, or molecular signatures present in blood, tissue, or other bodily fluids - that could serve as early warning signs of endometriosis or provide insights into its progression. By pinpointing these genetic markers and biomarkers, these studies seek to improve diagnostic accuracy, enable earlier detection, and pave the way for personalized treatment approaches tailored to an individual’s unique genetic and molecular profile.
Diagnostic trials
Diagnostic trials in endometriosis clinical research focus on improving and validating methods for diagnosing the condition. These trials aim to enhance the accuracy, speed, and effectiveness of diagnosing endometriosis, which can often be challenging due to its complex and variable symptoms.
Researchers might seek to develop and refine diagnostics tools and methods for enhancing the accuracy and early detection of endometriosis. This could include placing a focus on advanced imaging technologies like high-resolution ultrasound or MRI or identifying new biomarkers that could support earlier and more reliable diagnosis.
Interventional trials
Researchers use interventional trials for endometriosis to test and evaluate the effectiveness and safety of new or modified treatments and therapies. These trials are designed to directly intervene in the disease process or its symptoms and assess the impact of these interventions.
In interventional trials, researchers will seek to establish how safe and effective an intervention is. Medications could include novel hormone therapies, pain management medications, or other pharmacological agents. As surgery is an existing treatment for endometriosis, researchers can also use interventional trials to investigate new or improved surgical methods such as techniques for removing endometrial tissue. Non-pharmacological interventions may also be tested, such as lifestyle changes, dietary modifications, or complementary therapies.
Prevention trials
Prevention trials in endometriosis are designed to identify and evaluate strategies that can prevent the initial development of the disease or its recurrence following treatment. Given the chronic nature of endometriosis, these trials are crucial for reducing the incidence and recurrence of the condition, which in turn can lessen the physical, emotional, and financial burdens on patients.
Observational studies
Observational studies for endometriosis can be used to gather data on the disease's natural history, identify risk factors, and understand how various factors affect disease progression and treatment outcomes. Unlike interventional studies, observational studies do not involve manipulating variables or testing specific interventions. Instead, they observe and analyze existing conditions and patterns.
Researchers may track how endometriosis develops and progresses over time in individuals without intervening to help them understand the typical course of the disease and its variations among different patients. In this case, they would collect longitudinal data from patients over several years to document changes in symptoms, disease severity, and overall health.
Does endometriosis affect long term health?
It can. Endometriosis is associated with irritable bowel syndrome, migraine, anxiety and depression, and cardiovascular disease. A large 2024 study in the BMJ also found a somewhat higher risk of death before age 70 among women with surgically confirmed endometriosis, mostly driven by gynecologic cancers.
Who can participate in endometriosis clinical trials?
It depends on the study. Many endometriosis trials ask for a diagnosis confirmed by surgery, and some also ask which ASRM stage you are, from I to IV. Others work the other way around: the diagnostic studies on this page recruit women who live with chronic pelvic pain and have never been diagnosed. Observational studies often just follow people with endometriosis over time, with no medicine involved at all, and those tend to have the widest doors. Age limits, previous surgeries, and the hormonal medicines you already take can all matter. Women's health research has been underfunded for decades relative to how many people this condition affects, and studies are trying to reach the patients who were missed. Eligibility always varies by study.
Considering volunteering in a clinical trial? Check our guide!
Do endometriosis trial participants get paid?
Some studies offer compensation for time and travel, and study related care is typically provided at no cost to participants. Compensation varies by trial and is always described during the informed consent process before you agree to anything.
Curious whether clinical trials pay participants? Here's how compensation actually works.
How to enroll in an endometriosis clinical trial
Enrolling in a clinical trial studying endometriosis through our platform is a straightforward and user-friendly process. Here's how to get started:
- Identify Your Trial: Use our intuitive search bar or filter options to locate clinical trials specific to requirements. This first step simplifies the process of finding relevant research studies tailored to your needs.
- Select Your Preferred Location: To find trials conveniently located near you, simply input your preferred location into the dedicated filter bar on the left-hand side of the page.
- Explore Study Details: For in-depth information about each study, simply click the “Learn More” button. This will provide you with comprehensive details about the trial, including objectives, procedures, and eligibility criteria.
- Complete the Health Profile: After clicking on the “Get started” button you will be taken to our efficient 5-step application process to provide important health information. This helps us match you with the clinical trial that best fits your needs.
- Submit the Application: After completing the application, send it in. A clinical trial coordinator will review it and contact you regarding the possibility of participation.