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Endometriosis clinical trials

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NCT ID: NCT04614246 Terminated - Endometriosis Clinical Trials

Study to Gather Information How Well Three Different Doses of BAY1817080 Given Twice Daily Over 12 Weeks Work in Comparison to an Inactive Pill (Placebo) and Elagolix in Women Suffering From Pain Related to a Condition Where the Tissue That Usually Grows Inside the Womb Grows Outside of the Womb

SCHUMANN
Start date: January 29, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess safety and efficacy of BAY 1817080 compared to elagolix and placebo in women with symptomatic endometriosis. Study details include: - Study duration: 155 up to 285 days - Treatment duration: 84 days - Visit frequency: 3 laboratory every 2 weeks for participants on BAY 1817080 or placebo

NCT ID: NCT04372121 Terminated - Endometriosis Clinical Trials

Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain

EDELWEISS 5
Start date: March 23, 2020
Phase: Phase 3
Study type: Interventional

The primary objective of this extension study is to assess the maintenance of efficacy of linzagolix administered orally once daily for up to an additional 6 months (for up to 12 months of treatment in total) in women who have already completed 6 months of linzagolix treatment at a dose of 75 mg alone or of 200 mg in combination with ABT (E2 1 mg / NETA 0.5 mg), in the management of moderate to severe endometriosis-associated pain (EAP) in women with surgically confirmed endometriosis.

NCT ID: NCT04140175 Terminated - Endometriosis Clinical Trials

A Study of Women Receiving Standard of Care (SOC) for the Treatment of Pelvic Pain Due to Suspected or Confirmed Endometriosis and the Impact on the Disease or Symptom Progression.

Start date: January 20, 2020
Phase:
Study type: Observational

This study will describe historic, current, and evolving treatment pathways, treatments, and interventions in women with a suspected or confirmed diagnosis of endometriosis in order to better understand the impact of early intervention on the disease or its symptoms. Length of treatment is dependent on standard of care treatment provided and all study information will be collected during routine standard of care visits.

NCT ID: NCT04091191 Terminated - Endometriosis Clinical Trials

Evaluation of a Nutraceutical for Endometriosis Pain Relief

Start date: October 13, 2021
Phase: N/A
Study type: Interventional

Based on the EHP-30 questionnaire, the pain score and general well-being of all patients will be assessed with and without taking a specialized nutraceutical. These patients will be taking continuous oral contraception, for 3 months before inclusion till at least end of the study or not taking any oral contraception at all during the study due to contraindication(s).

NCT ID: NCT04013126 Terminated - Endometriosis Clinical Trials

Endothelial Dysfunction Among Woman With Endometriosis

Start date: August 12, 2019
Phase: N/A
Study type: Interventional

Endometriosis is a chronic disease defined as an ectopic endometrial tissue outside the, and associated with chronic inflammatory state and increased risk of atherosclerosis. Endothelial dysfunction plays an important and elementary role in the development of atherosclerosis. There are number of non-invasive tests for evaluating the endothelial function. One of them is FMD - "Flow Mediated Dilatation". Clinical studies proved the efficacy of this method in predicting cardio-vascular events in patients with established heart disease and also as an independent risk factor, better than the traditional ones. An alternative method, developed in recent years, is evaluation of peripheral blood vessels tone - "Peripheral Arterial Tonometry" - (PAT). It evaluates the pulsatile blood volume of the blood vessels in the fingertips during reactive hyperemia. The obtained value "reactive hyperemic index" (RHI) correlates well with FMD as well with coronary arteries endothelial dysfunction. it well suited as a clinical tool or as a test for a large-scale clinical study. Endothelial dysfunction has been demonstrated among woman with endometriosis. After surgical removal of endometrial implants there was a substantial improvement in the endothelial function, by imaging (using FMD) and by inflammatory markers In this study the investigators will follow the endothelial function among women undergoing endometrial implants surgical removal, before and after the surgery, using PAT technology (ENDOPAT system). Inflammatory markers and quality of life parameters will also be evaluated. The follow-up will include one meeting 6 weeks after the procedure The investigators expect an improvement in the endothelial function among women who had endometriosis implants removal.

NCT ID: NCT03986944 Terminated - Endometriosis Clinical Trials

A Phase 3 Study to Confirm the Efficacy and Safety of Linzagolix to Treat Endometriosis-associated Pain

Start date: May 23, 2019
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to demonstrate the efficacy and safety of linzagolix administered orally once daily for 3 months at a dose of 75 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, in the management of moderate to severe endometriosis-associated pain (EAP).

NCT ID: NCT03970330 Terminated - Endometriosis Clinical Trials

Low-Dose Naltrexone in Combination With Standard Treatment in Women With Endometriosis

Start date: January 16, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if the addition of Low Dose Naltrexone to standard endometriosis treatments will improve patient reported endometriosis associated pain.

NCT ID: NCT03950206 Terminated - Endometriosis Clinical Trials

Intraoperative Assessment of Ureteral Perfusion in Women With Endometriosis

Start date: June 1, 2019
Phase: N/A
Study type: Interventional

Deep infiltrating endometriosis (DIE) is a severe form of endometriosis in which lesions affect retroperitoneal tissue and pelvic organs wall. It is often characterized by pain (dysmenorrhea, dysuria, dyspnea, dyspareunia, and chronic pelvic pain) and infertility, drastically impacting on women' quality of life. It is typically multifocal, involving uterosacral ligaments, the upper third of posterior vaginal wall, bowel, bladder, and ureters. Indocyanine green (ICG) is an anionic tricarbocyanine molecule able to bind to plasma proteins into the vascular system and to become fluorescent if excited by near-infrared light (NIR). NIR-ICG imaging is used in gynecology for the intraoperative diagnosis of occult peritoneal and deep endometriosis at white light and to assess tissue perfusion and guide surgical strategy.

NCT ID: NCT03827174 Terminated - Chronic Pain Clinical Trials

Return to Work in Patients With Chronic Pain

UWORKin
Start date: August 14, 2019
Phase: N/A
Study type: Interventional

This study aims to evaluate whether a vocational behaviour change ability programme has any additional effect on return to work compared with return to work coordination only in persons with chronic pain.

NCT ID: NCT03573336 Terminated - Endometriosis Clinical Trials

Assess Safety and Efficacy of Vilaprisan in Subjects With Endometriosis

VILLENDO
Start date: July 4, 2018
Phase: Phase 2
Study type: Interventional

The primary objective of this study was to assess the efficacy and safety of two doses of vilaprisan compared to placebo in women with symptomatic endometriosis. The secondary objective of this study was to evaluate the safety and tolerability of two different doses of vilaprisan in women with symptomatic endometriosis. With the implementation of protocol version 4.0 dated 11-Dec-2018, no new subjects were enrolled. The objectives above cannot be reached as only limited data is available from subjects recruited before the temporary pause.