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118 active trials for Endometriosis

Study Of Oral Elagolix Tablets In Combination With Combined Oral Contraceptive Capsules/Tablets To Assess Dysmenorrhea Response In Adult Female Participants With Endometriosis And Associated Moderate To Severe Pain

Endometriosis is a painful disorder of the uterus affecting 6-10% of women of childbearing age. Endometriosis affects daily activities, social relationships, sexuality and sexual activity, and mental health. This study will evaluate how well elagolix in combination with combined oral contraceptives (COC) works within the body and/or how safe it is compared to placebo (does not contain treatment drug). This study will assess the dysmenorrhea (painful periods) response in participants with endometriosis and associated pain. Elagolix is an approved drug for the management of moderate to severe pain associated with endometriosis. Participants are randomly put in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. Adult female participants who still have periods with a diagnosis of endometriosis will be enrolled. Around 800 participants will be enrolled in the study at multiple sites in the United States, including Puerto Rico. Participants will receive oral elagolix or placebo tablets in combination with combined oral contraceptive (COC) or placebo capsules for 3 months. All the participants will receive elagolix tablets in combination with COC tablets from Month 4 through Month 18. There will be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Columbia, South CarolinaStart: August 2020
The Role of Expectations on Complaints and Well-being After Endometriosis Surgery in Women

Endometriosis is a prevalent disease in women of procreative age. Most endometriosis patients are affected in their daily life by complaints such as chronic pelvic pain, dysmenorrhoea, infertility, or pain during sexual intercourse. Yet, its etiology is poorly understood. Although laparoscopy is well known as the gold standard for treating endometriosis, 20-30% of treated women still show persistent complaints following successful laparoscopy. It has been widely recognized that expectations profoundly affect treatment courses and outcomes in many different health conditions. Additionally, evidence suggests that optimizing preoperative expectations can improve post-operative outcomes such as disability and return to work. The objective of this study is to investigate whether expectations also affect treatment course and outcome in women after endometriosis surgery. For this purpose, the investigators conduct a mixed-method observational cohort study to gather data on psychological factors, particularly treatment and symptom-related expectations, as well as complaints and well-being of patients after surgery. A sample of N = 300 women will be asked pre- and postoperatively to evaluate these psychological factors and indicators of treatment course and outcome. Overall, the study will last 12 months, including one assessment preoperatively (baseline), seven monthly assessments postoperatively, and a follow-up assessment 12 months after endometriosis surgery. The study aims to determine potential interactions between aforementioned psychological factors, their influence on the postoperative health, and the long- and short-term symptom course of patients with endometriosis. The study results will provide a better understanding of the symptom- and treatment course in women with endometriosis and subsequently supply clinical approaches to optimize treatment of endometriosis.

Start: August 2021
A Trial to Learn What Happens to Different Medicinal Forms of BAY2328065 When They Enter the Body and How Safe They Are in Healthy Male and Female Participants

Researchers are looking for a different way to treat women with a condition in which tissue that normally lines the uterus grows outside the uterus. This condition is called endometriosis. Before a treatment is available to all patients, researchers study it in clinical trials to better understand its safety and what happens to it in the body. BAY2328065 is being developed to help treat women who have endometriosis. Women with endometriosis often have very painful menstrual periods, as well as pain in the pelvic area which is not related to menstrual periods and pain during intercourse. Many women with endometriosis may also have problems becoming pregnant. The trial treatment, BAY2328065, works by blocking a certain protein that causes pain and swelling of the tissue and is thought to play a role in endometriosis. In this trial, the researchers want to compare what happens to different medicinal forms of BAY2328065 in the body. They also want to learn if eating a meal affects what happens to BAY2328065 in the body. This trial will include about 32 men and women who are aged 18 to 55. There will be 4 groups of participants in this trial. The participants in Groups 1, 2, and 3 will be men. The participants in Group 4 will be women. There will be 3 treatment courses to the trial for Groups 1, 2 and 3 and 1 treatment course for Group 4. During the trial, the participants in Groups 1, 2, and 3 will stay at the trial site for 15 days (3 times 5 days with times in between during which they stay at home). The participants in Group 4 will stay at the trial site for 16 days continuously. But, the trial will last about 6 weeks for the participants in Groups 1, 2, and 3. The trial will last about 9 weeks for the participants in Group 4. All of the participants in Groups 1 and 2 will take the different medicinal forms of BAY2328065, with and without food. All of the participants in Groups 1 and 2 will take dose "2" of BAY2328065 in all 3 treatment courses. In Group 1, they will take BAY2328065 one time each during the following treatment courses: A medicinal form of BAY2328065 without food in treatment course 1, then A medicinal form of BAY2328065 differing from the one used in treatment course 1 without food in treatment course 2, then The medicinal form of BAY2328065 used in treatment course 1 with food in treatment course 3 The participants in Group 2 will do the same, but they will take each form of BAY2328065 in a different order. Information gathered from Group 1 and 2 will help the researchers learn which form of BAY2328065 will be most suited to give to the participants in Groups 3 and 4. The participants in Group 3 will take 3 different doses of BAY2328065 with food in each treatment course. They will take one time each during the following treatment courses: Single administration of dose "1" in treatment course 1, then Single administration of dose "2" in treatment course 2, then Single administration of dose "3" in treatment course 3 This will help the researchers learn the safest dose to give to the participants in treatment course 4. The participants in Group 4 will either take dose "3" or "2" of BAY2328065 based on the results of treatment course 3, or a placebo. A placebo looks like a treatment but does not have any medicine in it. All of the participants will take either: Multiple administrations of dose "3" of BAY2328065 or dose "2" of BAY2328065, OR the placebo The participants will take BAY2328065 or placebo over 12 days and with food. The doctors/ healthcare staff will: take blood and collect urine samples check the participants' heart health The participants will: answer questions about how they are feeling say if they have any medical problems say if they have taken any medications

Mannheim, Baden-WürttembergStart: April 2021
ENDOMET - Novel Diagnostic Tools and Treatments for Endometriosis

Endometriosis is a chronic disease characterized by the presence of functional endometrial glands and stroma in ectopic locations outside the uterine cavity. The ectopic endometrial tissue responds to estradiol and other hormones similarly to the normal endometrium. Endometriosis is one of the most common benign gynecological conditions, as many as 5-10% of women in the reproductive age may be affected. In addition to pain which may be severe, subfertility is one of the typical problems associated with endometriosis and may be present in up to 40% of those affected. There is lack of a clear correlation between severity of pain and degree of compromised fertility. Different modes of treatment exist. Hormonal treatments are based on the suppression of estrogenic action on endometriosis as well as the endometrium. Unfortunately, discontinuation of the hormonal treatment typically results in a rapid recurrence of the disease. Surgery may alleviate the symptom for different lengths of time, however, curative treatment frequently involves hysterectomy with bilateral oophorectomy. In order to escape this radical treatment, new targeted therapy in the form of novel pharmacological agents would be of crucial importance. Presently, endometriosis can be reliably diagnosed only by laparoscopy. Since this is an invasive surgical procedure, new diagnostic tools would be warmly welcomed. Furthermore, as the progression of the disease is presently impossible to predict, new markers for the "malignancy" of each case are desperately needed. The aim of the investigators research is to identify expression of endometriosis specific RNAs/proteins. Evaluation of expression profiles in samples of endometriosis and endometrium of patients with careful clinical and surgical classification of endometriosis as well as healthy control women should initially enable to identify novel targets for new therapies and biomarkers. Particularly the different pain symptoms will be recorded annually and evaluated comprehensively. Furthermore, combined with an adequate 10-year follow up (based on a questionnaire, including fertility, received treatments and different pain symptoms; NRS), the study should enable for example to identify markers for endometriosis associated infertility as well as cases where the disease progresses very rapidly or reoccurs. Different forms of effective treatment may thereafter be designed following the identification of such factors.

HelsinkiStart: October 2005