Ongoing Clinical Trials for Endometriosis
Currently, there are 8 clinical trials investigating new treatments and diagnostic methods for endometriosis across Europe. These trials are exploring various approaches, from pain management medications to imaging techniques and fertility treatments, all aimed at improving the lives of women living with this condition.
Clinical trial locations
- Belgium
- Bulgaria
- Czechia
- Finland
- France
- Study on the Effect of Triptorelin Before Frozen Embryo Transfer in Patients with Endometriosis or Adenomyosis
- Study on Using Fluoroestradiol F-18 PET/CT for Detecting Endometriosis in Patients with Pain
- Study on the Use of PET Scans with Fludeoxyglucose (18F) for Diagnosing Endometriosis in Patients with Symptoms
- Study on the Effectiveness and Safety of OG-6219 and Naproxen Sodium for Women Aged 18-49 with Moderate to Severe Endometriosis Pain
- Germany
- Hungary
- Italy
- Latvia
- Netherlands
- Poland
- Romania
- Spain
- Sweden
Study on Esketamine for Treating Chronic Pain in Endometriosis Patients
This trial is testing whether esketamine, a medication with anesthetic and potential antidepressant effects, can help reduce chronic pelvic pain in women with endometriosis. The study will compare an 8-hour infusion of esketamine with a placebo to measure its effectiveness.
Who can join: Pre-menopausal women over 18 years old who have been diagnosed with endometriosis through imaging or surgery are eligible. You need to experience mild to severe chronic pelvic pain scoring 6 or higher on a scale from 0 to 10, and your pain should not improve with standard medications like paracetamol or anti-inflammatory drugs. You must also be recommended for or on a waiting list for surgery to remove endometriosis tissue, and not be using strong opioid pain medications.
Who cannot join: Male patients, those without a confirmed diagnosis, individuals outside the specified age range, and those from vulnerable populations are excluded from this study.
What the trial involves: The main focus is to assess how the esketamine infusion affects chronic pelvic pain levels measured using a numeric rating scale. The study will also monitor changes in quality of life, any depressive symptoms, and possible side effects. Some participants may also receive ondansetron to manage potential side effects from the treatment.
Medication being tested: Esketamine hydrochloride is administered through an intravenous infusion directly into the bloodstream. It works by blocking certain receptors in the brain that may help reduce pain perception.
Study on the Effectiveness and Safety of AMY109 and Desogestrel for Women with Endometriosis
This study is evaluating a new investigational treatment called AMY109, given as an injection, and comparing it to the hormone medication desogestrel, commonly used in contraceptive pills. The trial will assess how well these treatments reduce the severity of the disease as seen through medical imaging.
Who can join: Women aged 18 to 49 who have moderate to severe endometriosis-related pain are eligible. You need to have a pain score of 4 or higher on at least 4 days for non-menstrual pelvic pain and on at least 2 days for menstrual pain during the screening period. You must also agree to switch from your usual pain medications to those allowed by the study. Some participants may need to have had a recent laparoscopy diagnosis or show specific lesions on MRI scans.
Who cannot join: Men cannot participate, nor can those outside the specified age range or individuals from vulnerable populations.
What the trial involves: The study will use regular MRI scans to monitor changes in endometriosis severity. Some participants in the UK may undergo laparoscopic surgery after treatment to further assess the condition. Throughout the trial, participants will attend scheduled visits to report symptoms and side effects.
Medications being tested: AMY109 is an investigational medication being studied for its potential to reduce disease severity. Desogestrel is a well-established hormonal treatment that works by altering hormone levels to reduce endometrial tissue growth and alleviate pain.
Study of cabergoline compared to dienogest and ethinylestradiol for reducing endometriosis symptoms and lesion size in women with confirmed endometriosis
This trial compares cabergoline tablets with standard treatments (dienogest or combined birth control pills) to see which is better at reducing the size of endometriosis growths and relieving pelvic pain over a 6-month treatment period.
Who can join: Women aged 18 to 40 who are still having menstrual periods and have a confirmed diagnosis through ultrasound, MRI, or laparoscopy can participate. You need to have experienced pelvic pain for at least one month with a pain score of 3 or higher. Your body mass index should be between 18 and 35, and you must not have used cabergoline in the past 3 months or have allergies to the study medications.
Who cannot join: Those with severe allergies to cabergoline or similar medications, pregnant women, breastfeeding mothers, people with heart valve disease, severe liver problems, uncontrolled high blood pressure, history of excessive tissue scarring, or mental health conditions that could affect participation are excluded. Anyone who has participated in another clinical trial within the past 30 days or has a history of recent drug or alcohol abuse also cannot join.
What the trial involves: Participants will receive either cabergoline (0.5 mg twice per week) or standard treatment. Regular check-ups will track changes in lesion size using imaging methods, pain levels using visual scales, hormone levels through blood tests, and overall quality of life through questionnaires. Side effects such as nausea, vomiting, dizziness, and irregular bleeding will be monitored.
Medications being tested: Cabergoline is a dopamine agonist that affects hormone levels and is being tested for its ability to shrink endometriotic lesions and reduce symptoms. Dienogest is a progestin hormone medication, and combined hormonal contraceptives contain both estrogen and progestin, both used as standard treatments for endometriosis.
Study on Cabergoline for Pain and Fertility in Women with Endometriosis and Infertility
This study investigates whether cabergoline can help reduce pain and improve fertility in women with mild to moderate endometriosis who are experiencing difficulty conceiving. The trial will compare cabergoline with a placebo over a period of time.
Who can join: Women aged 20 to 37 with mild or moderate endometriosis diagnosed through surgery, ultrasound, or strong clinical suspicion are eligible. You need to have endometriosis-related menstrual pain scoring greater than 3 on a pain scale and have been experiencing primary or secondary infertility for at least one year. Your infertility should be caused by mild or moderate endometriosis or be unexplained, and you must have regular ovulatory menstrual cycles.
Who cannot join: Men, those without endometriosis, individuals without infertility, those with severe endometriosis, and anyone outside the specified age range cannot participate.
What the trial involves: The study focuses on assessing changes in pain levels (menstrual pain, weekly pelvic pain, and pain during intercourse) using a numeric rating scale. Participants will be monitored throughout the treatment and after three natural or ovulation induction cycles to evaluate any improvements in symptoms and fertility status.
Medication being tested: Cabergoline (Dostinex 0.5 mg tablets) works by reducing prolactin hormone levels in the body, which may help decrease endometrial tissue growth and alleviate pain while potentially improving chances of conception.
Study on the Effect of Triptorelin Before Frozen Embryo Transfer in Patients with Endometriosis or Adenomyosis
This study tests whether using triptorelin, a GnRH agonist medication, before frozen embryo transfer can improve pregnancy rates in women with endometriosis and/or adenomyosis who are undergoing assisted reproductive technology.
Who can join: Women aged 18 to 36 with endometriosis and/or adenomyosis confirmed by MRI are eligible. You must have undergone in vitro fertilization with all embryos frozen, and a blastocyst frozen embryo transfer must be planned. You need to have a normal uterine cavity, have signed a consent form, and be affiliated with a health insurance plan.
Who cannot join: Men, those without a diagnosis of endometriosis or adenomyosis, individuals outside the specified age range, and those from vulnerable populations are excluded.
What the trial involves: The study will monitor clinical pregnancy rates (confirmed by fetal heartbeat on ultrasound), the number of successful embryo implantations, incidence of miscarriage, and side effects related to low estrogen levels such as hot flashes or mood swings. Some participants will receive triptorelin while others receive a placebo.
Medication being tested: Triptorelin (DECAPEPTYL L.P. 11,25 mg) is administered as a prolonged-release injection (either intramuscular or subcutaneous) that releases medication over three months. It works by temporarily suppressing natural hormone production to create a more favorable environment for embryo implantation.
Study on Using Fluoroestradiol F-18 PET/CT for Detecting Endometriosis in Patients with Pain
This trial is testing a new imaging method called [18F]-FES PET/CT to see how well it can detect and describe endometriosis lesions compared to MRI and surgical findings. The goal is to improve diagnosis and understanding of the condition.
Who can join: Women over 18 years old experiencing pain with a visual analog scale score of 4 or higher, or those with a lower pain score being treated for infertility, are eligible. You must have previously undergone surgery for endometriosis and need to have a suitable preoperative MRI available. You must also provide informed consent and be a member of a social security scheme.
Who cannot join: Men and individuals from vulnerable populations cannot participate. There are also age restrictions, with participants needing to be adults within a specific range.
What the trial involves: Participants will receive an injection of fluoroestradiol F-18 (EstroTep 500 MBq/mL) intravenously, followed by a PET/CT scan. The scan evaluates the presence and characteristics of lesions by analyzing how much radioactive substance they absorb. The results will be compared to MRI findings and surgical observations to assess the imaging method’s accuracy.
Diagnostic tool being tested: Fluoroestradiol F-18 is a radioactive substance that binds to estrogen receptors commonly present in endometriosis tissue, allowing doctors to see these areas more clearly on PET/CT scans.
Study on the Effectiveness and Safety of OG-6219 and Naproxen Sodium for Women Aged 18-49 with Moderate to Severe Endometriosis Pain
This large international trial is testing a new medication called OG-6219 at three different dose levels (50 mg, 100 mg, or 150 mg) compared to a placebo to see how well it reduces pelvic pain associated with endometriosis.
Who can join: Pre-menopausal women aged 18 to 49 with moderate to severe endometriosis-related pelvic pain are eligible. You need to have a pain score of 4 or higher during your last menstrual cycle and have been diagnosed with endometriosis through surgery within the last 4 months to 10 years. You must have regular menstrual cycles (21 to 32 days) without hormonal therapy, a normal breast examination, and be willing to use two forms of non-hormonal contraception. You must also demonstrate compliance with electronic diary entries and use only study-provided rescue medication during the screening period.
Who cannot join: Men and individuals from vulnerable populations are excluded. Only those experiencing endometriosis-related pain are eligible.
What the trial involves: The study lasts several months with three treatment cycles. Participants take the medication or placebo twice daily and record their pain levels and any rescue medication use in an electronic diary. Regular study visits include assessments, transvaginal ultrasounds, and blood tests to monitor safety and effectiveness.
Medication being tested: OG-6219 is an investigational oral medication being tested at different doses to determine which amount works best for reducing pelvic pain while maintaining safety. Naproxen sodium is provided as rescue medication for additional pain relief when needed.
Study on the Use of PET Scans with Fludeoxyglucose (18F) for Diagnosing Endometriosis in Patients with Symptoms
This study evaluates whether PET scans using fludeoxyglucose (18F) can accurately identify the number and location of endometriosis lesions before surgery, potentially improving diagnosis and treatment planning.
Who can join: Women aged over 18 and under 50 with symptomatic endometriosis requiring surgery are eligible. You must have at least one typical endometriosis lesion greater than 5mm visible on an MRI scan and have signed an informed consent form. You must also be affiliated with a social security scheme.
Who cannot join: Men and individuals from vulnerable populations cannot participate. There are specific age restrictions as well.
What the trial involves: Participants will receive intravenous injections of fludeoxyglucose (18F), furosemide (a diuretic to help clear the radioactive substance), and iohexol (Omnipaque, a contrast agent). The PET scan results will be compared to surgical findings to assess diagnostic accuracy. The study aims to determine if PET scans can detect lesions not visible on MRI and provide better pre-surgical planning information.
Diagnostic tool being tested: Fludeoxyglucose (18F) is a radioactive substance that highlights areas of increased metabolic activity in the body, helping to visualize endometriosis lesions during PET scanning.
Summary
The 8 ongoing clinical trials for endometriosis represent a diverse range of research approaches across 14 European countries. These studies focus on three main areas: pain management, fertility improvement, and diagnostic advancement.
Several trials concentrate on pain relief using different medications. Esketamine, cabergoline, and the investigational drug OG-6219 are all being tested for their ability to reduce chronic pelvic pain. The OG-6219 study is particularly notable as it is being conducted across 10 countries (Poland, Belgium, Italy, Germany, Hungary, Sweden, Czechia, France, Bulgaria, and Latvia), making it the most widespread trial in this collection.
France hosts the most trials with 4 studies, focusing primarily on diagnostic imaging techniques and fertility treatments. Two French trials are investigating advanced imaging methods using radioactive tracers to better detect and characterize endometriosis lesions, which could lead to improved non-surgical diagnosis in the future.
Fertility-focused research appears in the Finnish and French trials, with studies examining how medications like cabergoline and triptorelin might improve conception rates in women with endometriosis.
Interestingly, cabergoline appears in three separate trials across different countries (Spain, Finland, and France), suggesting growing research interest in this dopamine agonist for treating endometriosis symptoms and improving fertility outcomes.
The trials generally target women aged 18 to 49, with most requiring confirmed diagnosis through surgery or imaging and documented pain levels of 3 or higher on pain scales. The variety of approaches being tested reflects the complex nature of endometriosis and the ongoing search for better treatment options for those affected by this condition.
