Learn More About Endometriosis Research Studies

What Are Endometriosis Clinical Trials?

Endometriosis is a pelvic inflammatory disease where cells similar to the lining of the uterus grow outside the uterus. Endometriosis mainly involves the fallopian tubes, ovaries, and the tissue lining the pelvis. It is rare for endometriosis-like tissues to grow outside the pelvic region.

Endometriosis can cause severe pain during menstrual periods and may lead to infertility. There is a need for more endometriosis clinical trials because it has no cure. Research is currently focused on risk factors (both environmental and genetic), natural progression, and the pathophysiology of endometriosis. Medical professionals aim to ease the condition’s symptoms to improve the patient's quality of life.

Researchers have identified several factors that can increase a person’s risk for endometriosis, such as never giving birth, prolonged menstrual periods that last over one week, high levels of estrogen in the body, and frequent menstrual cycles that occur more frequently than 28 days.

Why Is Endometriosis Being Studied Through Clinical Trials?

Endometriosis is a very complex condition with a large interindividual variance in symptoms that make diagnosis difficult for doctors. It is not uncommon for doctors to misdiagnose endometriosis, leading to more complications for the patient. More endometriosis clinical trials are needed to help doctors know how to diagnose the condition accurately.

One study found that 75.2% of all endometriosis cases go undiagnosed. The condition has overlapping symptoms with bowel and digestive disorders, contributing to misdiagnosis.

Failing to treat endometriosis can severely affect the patient's quality of life, including work, education, and mental health. Researchers currently don’t understand how it is caused, and there is no cure for it, requiring more medical investigation. 40% of women with endometriosis have infertility.

The inflammation from endometriosis can damage the egg and sperm and interfere with their movement through the uterus and fallopian tubes. In some cases, endometriosis can even block fallopian tubes by forming scar tissue. The pain from endometriosis can adversely impact the patient’s quality of life. Despite its prevalence in patients, very little research has been done to study the cause and treatment of endometriosis-related pain.

Healthcare professionals may utilize several tests, including transvaginal MRI scans and ultrasound, to diagnose the condition. Laparoscopy is often used to help make a firm diagnosis of endometriosis. This is an invasive surgery where a camera is inserted in the abdomen to view the pelvic organs.

There is a strong need for more endometriosis research studies and clinical trials to help doctors diagnose the condition at an early stage instead of several years.

What Are The Types of Treatments Available For Endometriosis?

Doctors prescribe treatment for endometriosis by carefully evaluating the patient’s symptoms, disease progression, and whether they want to have children. Surgery and medication are commonly used to treat endometriosis. Medication, such as nonsteroidal anti-inflammatory drugs, is used to help with the pain.

It is unclear if these medications can alleviate the pain caused by endometriosis. Estrogen inhibitors may be prescribed to patients because endometriosis requires high estrogen levels. Birth control pills and shots can be used to alleviate estrogen. However, birth control can lead to side effects such as weight gain, irregular bleeding, and headaches.

One alternative is to use the gonadotropin-releasing hormone. It suppresses reproductive hormones and the growth of lesions. This can cause menopausal symptoms such as sleep disruption, joint pain, tiredness, hot flashes, and vaginal dryness. Doctors may prescribe low doses of HRT to minimize the symptoms.

Surgery is often reserved for extreme endometriosis cases leading to severe pain. Laparoscopy can be used to remove endometrial lesions to provide pain relief. However, reports indicate that most women may experience the pain within two years of removing the lesions.

Some patients opt for a hysterectomy (uterus removal) to alleviate the symptoms. However, research on whether this helps with endometriosis or not is inconclusive.

What Are Some Recent Breakthrough Clinical Trials For Endometriosis?

Endometriosis clinical trials provide professionals with more information to help them diagnose and manage symptoms. Here are some breakthrough research studies in endometriosis that can help treat the condition.

2018: Etonogestrel and Levonorgestrel for Managing Endometriosis - This study investigated the effectiveness of 52 mg LNG-IUS and ENG contraceptives in managing endometriosis-related pain. Women were assigned to groups that used an ENG implant or an LNG IUS implant. The impact of the implants was observed over the course of six months.

A visual analog scale was used to evaluate the effectiveness of the contraceptives. It was found that both contraceptives significantly improved the VAS scores for endometriosis-related pelvic pain with similar results. Health-related QoL scores increased significantly in all domains of the modular and core segments, with no differences between the treatment groups. It was concluded that both contraceptives significantly improved QoL in patients with endometriosis.

2020: Supplementation with vitamin D or Omega-3 Fatty Acids - This randomized controlled trial investigated supplementation with vitamin D and omega-3 fatty acids in managing endometriosis-related pain in adolescents and young women (12-25 years old). Researchers measured pain using a visual analog scale (VAS). Secondary endpoints were catastrophizing, pain medication usage, and quality of life.

Patients were randomly assigned into groups that received vitamin D3 and fish oil or just a placebo for six months. It was found that supplementation with vitamin D led to significant improvement in pelvic pain; however, they were very similar to placebo. However, supplementing with fish oil reduced VAS pain by half. More studies are needed to study how supplements can help with endometriosis-related pain.

2021: Vitamin C and E Supplementation on Women with Endometriosis - It is believed that oxidative stress may cause endometriosis. This randomized controlled trial investigates the use of Vitamin C and E supplementation on oxidative stress in women struggling with endometriosis. 60 women with pelvic pain were randomized to group A which received vitamin C and vitamin E supplementation, and group B, which received placebo pills for eight weeks.

It was found that vitamin C and E supplementation significantly reduced ROS and MDA in women compared to the placebo group. There was no decline in total antioxidant capacity. With that said, the severity of dyspareunia, dysmenorrhea, and pelvic pain significantly decreased in the group after receiving vitamin C and E supplementation. This indicates that vitamin supplements can help manage the symptoms of endometriosis more effectively.

2021: Using Dienogest vs. Combined Oral Contraceptive for Managing Endometriosis - This randomized controlled trial compared the impact of dienogest with contraceptive pills (Yasmin) for managing pelvic pain caused by endometriosis. 70 patients with endometriosis were randomized to groups that either received 2mg/day dienogest (Visanne) or 0.3 mg COC (comprising of 3 mg drospirenone, 0.03 mg Ethinyl estradiol, and Yasmin).

The trial’s outcome was assessed using a visual analog scale (VAS). Secondary variables included dyspareunia, dysmenorrhea, pelvic pain, and quality of life. Both treatments significantly improved VAS scores with no significant differences. It was determined that dienogest had comparable effects as COC Yasmin for relieving endometriosis-related pain. However, dienogest had fewer side effects and a better safety profile than COC Yasmin.

2021: Relugolix for Managing Endometriosis-Associated Pain - This double-blind, placebo-controlled clinical trial investigated the use of Relugolix, an oral gonadotropin-releasing hormone, to see if it relieved endometriosis-related pain. Patients were randomized into groups that received relugolix in different dosages (10 mg, 20 mg, and 40 mg), placebo, and leuprorelin, over 12 months.

The primary endpoint was the change in the Visual Analog Scale (VAS) score for pelvic main. It was found that oral administration of Relugolix alleviates endometriosis-related pain. Major adverse effects of Relugolix were menorrhagia, irregular menstrual, bone density loss, and metrorrhagia. Higher Doses of Relugolix yielded better results and were well tolerated.

2022: Effect of Therapeutic Exercise on QoL in Women with Endometriosis - This randomized controlled trial explored the impact of therapeutic exercise (focused on tolerance to exertion and lumbopelvic stabilization) on women diagnosed with endometriosis. 22 women with endometriosis were randomized to the Physio-EndEA and usual care groups. The Physio-EndEA group took part in various exercises, including aerobic and resistance training supervised by a trained physiotherapist.

The primary outcome of the study was health-related Quality of Life metrics. Secondary outcomes included muscle thickness, strength, pain thresholds, flexibility, and body balance. Findings from this trial can be of great benefit to women with endometriosis.

Who Are Some Of The Key Institutions Conducting Endometriosis Clinical Trial Research?

The John Hopkins Endometriosis Center is a leading institution that provides women with access to endometriosis treatment. The center aims to provide the best possible individualized care to patients with the painful condition. They have led extensive research and develop novel treatment methods for managing endometriosis. Their primary interest is to remove endometrial lesions while maintaining fertility with minimally invasive surgery and robotic techniques.

Endometriosis CaRe Oxford is one of the foremost authorities in research and clinical care into endometriosis. They are affiliated with the Nuffield Department of Women’s Reproductive Health of the University of Oxford. Their research focuses on improving the understanding of endometriosis, developing non-surgical methods for diagnosing the condition, and finding more effective treatments. The researchers also seek to identify the primary causes of endometriosis.

Boston Center for Endometriosis has a team of national and international specialists who provide cutting-edge treatment for endometriosis. Their physicians have conducted research studies, clinical trials, and published papers about endometriosis in medical journals. The center has helped women of all ages, including adolescents and the elderly.

Kristin Elizabeth Patzkowsky, M.D., is an associate professor of Gynecology and Obstetrics. She received her medical degree from the University of Maryland School of Medicine and has several years of experience in treating women with reproductive difficulties. She also specializes in endometriosis using minimally invasive surgery.

Khara Michelle Simpson, M.D., is a Vice Char Quality and Safety at John Hopkins Hospital. Before joining John Hopkins, she taught obstetrics and gynecology at Columbia University Medical Center. Her areas of expertise include minimally invasive surgery for endometriosis, ovarian cysts, and fibroids. Khara completed her M.D. from Howard University College of Medicine and her medical residency at the John Hopkins University School of Medicine.