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Endometriosis clinical trials

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NCT ID: NCT05909579 Recruiting - Endometriosis Clinical Trials

Investigating the Effectiveness of PelvicSense(R) on Pain and Sexual Outcomes in Endometriosis

Start date: November 2, 2023
Phase: N/A
Study type: Interventional

This study will examine the effectiveness of the PelvicSense 3-month online program on pain and other outcomes in those with endometriosis. This study is prospective in nature and will involve several assessment points: baseline, immediately post-treatment (at the end of the 3 month program), and 3-month follow up. All aspects of the study will be conducted remotely (e.g., online, email, video calls), and participants will be at least 18 years of age, fluent in English, and experience pain due to endometriosis for at least 3 months with a physician diagnosis. Participants are expected to continue their treatment as usual and this information will be documented throughout the study.

NCT ID: NCT05894135 Recruiting - Endometriosis Clinical Trials

Efficacy and Safety of BG2109 in Chinese Subjects With Endometriosis

Start date: July 14, 2023
Phase: Phase 3
Study type: Interventional

The objective of this study is to demonstrate the efficacy and safety of BG2109 administered orally once daily at a dose of 100 mg alone or of 200 mg in combination with add-back hormone replacement therapy (ABT: estradiol (E2) 1 mg / norethisterone acetate (NETA) 0.5 mg) versus placebo, while under randomized treatment, in the management of moderate to severe endometriosis-associated pain (EAP) in chinese women with surgically confirmed endometriosis

NCT ID: NCT05863663 Recruiting - Quality of Life Clinical Trials

Chronic Pelvic Pain in Endometriosis

Start date: January 28, 2023
Phase:
Study type: Observational

Endometriosis is a chronic, inflammatory disease affecting 10% (1 out of 10) of women of reproductive age. Pelvic pain is common among women with endometriosis. Women with chronic pelvic pain conditions have elevated rates of relational stress and lower quality of life. The aim of our study is to analyse the extent of pelvic pain associated with endometriosis, as well as the study focuses on correlations between pelvic pain and physical activity, pain-related self-efficacy, perceived stress and different aspects of health related quality of life.

NCT ID: NCT05862272 Recruiting - Endometriosis Clinical Trials

A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endometriosis

Start date: August 14, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this clinical trial to characterize changes in bone mineral density during continuous treatment with relugolix combination tablet for up to 48 months (4 years) and 1 year of post-treatment follow-up in premenopausal women with heavy menstrual bleeding associated with uterine leiomyomas (fibroids) or with moderate-to-severe pain associated with endometriosis.

NCT ID: NCT05831735 Recruiting - Quality of Life Clinical Trials

The CRESCENDO Program (inCRease Physical Exercise and Sport to Combat ENDOmetriosis)

CRESCENDO
Start date: May 29, 2023
Phase: N/A
Study type: Interventional

Symptoms due to endometriosis cause psychological distress and interpersonal difficulties. However, studies on the psychological and social consequences of endometriosis are scarce, none has investigated life-partners' view of the disease and its consequences, and all adopt cross-sectional designs. Research highlights the beneficial effects of adapted physical activity (APA), on chronic diseases. Thus, APA may have a beneficial effect on the symptoms and the psychological and social consequences of endometriosis. However, studies questioning the link between PA and endometriosis are rare. The scarcity of studies can be explained by the fact that due to the painful symptoms caused by the disease; women avoid practicing. It is worth noticing that, in the specific context of endometriosis, the barriers and facilitators to PA are not clearly identified. Otherwise, due to their cross-sectional design, it is not possible for these studies to establish a causal link between PA and endometriosis. A RCT is needed to test the effects of PA on endometriosis and its consequences. The investigators' ambition is to fill these gaps in the existing literature and to allow a more comprehensive view of the phenomena at play in the relation between PA and endometriosis. To this end, the investigators will seek to achieve 2 objectives: 1. to identify the perceived effects of the disease on different areas of patients' lives, specifically areas related to PA, and to examine the reasons why patients are or are not physically active using a mixed methodology. Life-partners and women who do not suffer from this disease will also be involved in this study. 2. to investigate the effects of an APA program which includes therapeutic patient education (TPE) on 3 primary outcomes: perceived pain, QoL, and PA. A complementary aim is to determine the effect of the program on psychosocial and motivational variables, and on physiological variables. Patients will be randomly assigned to 3 groups: (1) control, (2) APA, (3) APA + TPE. The investigators hypothesize that the program could (H1) complement current treatments for endometriosis by reducing pain, increasing QoL, increasing PA, (H2) have beneficial effects on patients' physical, psychological and social health as well as physiological factors.

NCT ID: NCT05824819 Recruiting - Endometriosis Clinical Trials

Endometriosis and Peritoneal Dysbiosis

Start date: May 1, 2023
Phase: N/A
Study type: Interventional

Endometriosis is a complex clinical syndrome that impairs many aspects of a woman's life, characterized by a chronic estrogen-dependent inflammatory process, mainly affecting the pelvic organs, with ectopic presence of tissue analogous to the uterine mucosa (endometrium). Despite intensive research in the field of etiopathogenesis, its cause has not yet been determined, and treatment remains symptomatic. Endometriosis causes two main complications, i.e. pelvic pain syndrome and infertility. In recent years, thanks to the analysis of the human microbiome, it has become possible to deepen the knowledge of the physiological and pathological interactions between microorganisms inhabiting various body areas and the host. Bacteria may enter the peritoneal cavity in the mechanism of retrograde menstruation and translocate from the intestines, and then promote the development of local and systemic inflammation, leading to the symptoms of endometriosis. The study is to determine whether the presence of a specific intestinal, peritoneal and uterine microbiome correlates with endometriosis stage and whether its presence predisposes to increased pain or infertility. Concordance or divergence of bacterial populations inhabiting the peritoneal and uterine cavities could have clinical implications, i.e. the possibility of empirical antibiotic therapy in patients undergoing only endometrial aspiration biopsy and not opting for surgical treatment.

NCT ID: NCT05812937 Recruiting - Endometriosis Clinical Trials

Intraoperative Intraabdominal Ultrasound for Endometriosis

Start date: January 1, 2022
Phase:
Study type: Observational

The diagnosis of bowel endometriosis lesions is in most cases a combination of anamnesis, clinical exam, transvaginal ultrasound (and/or MRI and/or endorectal sonography) and laparoscopy. Both the transvaginal ultrasound as well as the MRI have showed a great accuracy with very good sensititivity and specificity regarding the imaging diagnosis of bowel endometriosis. The conventional laparoscopy contributes to the diagnosis of bowel endometriosis by visualizing the nodules and palpating the deep endometriosis nodule using the instruments, therefor offering the surgeon a haptic feedback by grasping, pushing and rolling the bowel wall and the nodules. Horace Roman and Dan Martin showed that 25% of patients undergoing a conventional laparoscopic segmental bowel resection with a minilaparotomy hat palpable non-visualized endometriosis nodules. These nodules could be directly palpated with the hands because the bowel was exteriorized through the minilaparotomy. The direct palpation of the bowel offers of course a superior haptic feedback compared to the haptic feedback offered by the laparoscopic palpation using the instruments. However this was a direct palpation of only the oral part of the bowel. The aboral part of the bowel caudal to the staple line could not be evaluated by direct palpation. New surgical techniques for the segmental bowel resection with transvaginal/transanal NOSE(natural orifice specimen extraction) have been described in the last years. The novel techniques avoid the minilaparotomy and assure a 100% minimal invasive approach offering better esthetic outcomes. However in such cases a direct palpation of the bowel wall using the hands in order to identify non- visualizable nodules is not possible as the bowel remains the whole time of the procedure inside of the abdomen. On the other side the robotic-assisted laparoscopy doesn't offer the surgeon a haptic feedback at all. In these cases the surgeon has to rely on the visual aspects of the lesions and therefor "touch" the lesions with his eyes - the visual information should replace the haptic feedback. So in the case of a robotic assisted laparoscopic segemental bowel resection with a NOSE it is not possible to palpate the bowel at all - neither with instruments, not with the hands. Other surgical techniques used to excise smaller colorectal nodules are the rectal shaving and the full thickness excision (disc excision) using a circular stapler. In these situations the surgeon has to rely exclusively on the visual information as well on the haptic feedback given by the conventional laparoscopic instruments. In more than 30% of the cases of full thickness rectal resection the resection the margins are infiltrated by the endometriosis nodules. All the above mentioned situations raise the question of the radicallity in terms of healthy resection margins and of multifocal lesions that cannot be visualized and/or palpated. In this study we are evaluating the diagnostic value of the intraoperative intraabdominal ultrasound for deep infiltrating colorectal endometriosis.

NCT ID: NCT05801523 Recruiting - Endometriosis Clinical Trials

Laparoscopic Therapy of Endometrioma: Sclerotherapy vs Cystectomy in Patients With Unfinished Reproductive Plans

Start date: February 1, 2023
Phase: N/A
Study type: Interventional

The aim of this prospective randomized study is to compare laparoscopic sclerotherapy to cystectomy in following: AMH dynamics, endometrioma recurrence, complications, pregnancy rate, assisted reproduction methods success rate, live birth rate

NCT ID: NCT05788978 Recruiting - Endometriosis Clinical Trials

Self-Care Behaviors Scale in Endometriosis

Start date: March 16, 2023
Phase:
Study type: Observational

In this study, it was aimed to develop a reliable and valid scale to measure the self-care behaviors of women with endometriosis.

NCT ID: NCT05770297 Recruiting - Endometriosis Clinical Trials

Effect of Propolis Administration for Dysmenorrhea in Endometriosis Patient With Levonorgestrel Implant Therapy

Start date: July 12, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to investigate the effect of propolis administration on dysmenorrhea in endometriosis patient. the main questions it aims to answer are: - Does the propolis administration reduce symptoms of dysmenorrhea in endometriosis? - Does the propolis administration reduce the amount of oxidative stress biomarkers in endometriosis? - Does the propolis administration reduce the amount of Inflammatory biomarkers in endometriosis? Participants will be given an intervention in the form of propolis at a dose of 1 drop per 10 kilogram of body weight per administration, twice a day. there will be a control group that will be given an intervention in the form of a placebo containing 70% caramel alcohol dye solution.