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Endometriosis clinical trials

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NCT ID: NCT04916171 Active, not recruiting - Clinical trials for Polycystic Ovary Syndrome

Determination of the Incidence of Endometriosis and or Adenomyosis in Patients Diagnosed With Polycystic Ovary Syndrome, or the Incidence of Polycystic Ovary Syndrome in Patients Diagnosed With Endometriosis and or Adenomyosis

Start date: June 1, 2021
Phase:
Study type: Observational

The study was designed as a multicenter, prospective cross-sectional cohort study. The research population will consist of patients under the age of 40, diagnosed with endometriosis and/or adenomyosis and polycystic ovary syndrome, who applied to the obstetrics and gynecology outpatient clinics in 13 centers. According to the results of the sample size analysis, it was planned to terminate the study when 1225 patients with polycystic ovary syndrome and 1225 patients with endometriosis and/or adenomyosis were recruited.

NCT ID: NCT04808843 Active, not recruiting - Clinical trials for Endometriosis Associated Pelvic Pain

A Study to Learn More About How Safe Dienogest is and How Well it Works Under Real World Conditions in Indian Women With Endometriosis

VISAGE
Start date: May 13, 2022
Phase:
Study type: Observational

Endometriosis is a condition that affects women, usually during their reproductive years. In women with endometriosis, the tissue that normally covers the inside of the womb grows outside the womb. This can cause pain during their periods or during sex, and constant pain in the pelvis. Endometriosis can decrease a woman's quality of life. It also requires long-term treatment to control the symptoms. The study drug, dienogest, has already been approved as a treatment for endometriosis associated pelvic pain. Sometimes, researchers continue studying a treatment after it has been approved to learn more about its safety. In this study, the researchers want to learn more about any medical problems the patients have while taking dienogest. To answer this question, the researchers will collect the medical problems the patients have after taking dienogest and that may or may not be related to dienogest. These medical problems are also known as adverse events. They will also collect information about the endometriosis associated pelvic pain. The pain measured with a standard rating scale called EAPP (endometriosis-associated pelvic pain) before treatment start and after 6 months of treatment will be compared. The trial will include women with endometriosis associated pelvic pain whose doctors have decided to start treating them with dienogest. It will include about 160 women in India who are at least 18 years old. All of the patients will take dienogest based on their doctor's instructions. They will then visit their study site 3 times over 6 months. At these visits, their doctors will ask them questions about how they are feeling and what medications they are taking. The doctors will do tests to measure the pain caused by the patients' endometriosis and any other symptoms. The doctors will also do physical examinations and check the patients' overall health.

NCT ID: NCT04756037 Active, not recruiting - Contraception Clinical Trials

Study of the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are at Risk for Pregnancy

SERENE
Start date: March 18, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the contraceptive efficacy of relugolix combination therapy.

NCT ID: NCT04630990 Active, not recruiting - Endometriosis Clinical Trials

Study Of Oral Elagolix Tablets To Assess the Tolerability and Change in Disease Symptoms in Adult Female Participants With Moderate to Severe Endometriosis-associated Pain

ENDORSE
Start date: December 14, 2020
Phase:
Study type: Observational

Endometriosis is an abnormal, estrogen-dependent growth of endometrial tissue outside the uterus that frequently results in dysmenorrhea and pelvic pain and often causes infertility. Endometriosis is a significant burden on the quality of life of women. This study will assess the tolerability and how effective elagolix is in changing the disease symptoms in adult female participants with endometriosis. Elagolix is an approved drug for treatment of endometriosis. Adult female participants with a diagnosis of endometriosis, who are prescribed elagolix by their physicians, in accordance with local clinical practice and label will be observed for up to 24 months. Around 80 female participants will be enrolled in the study in Israel. Participants will receive Elagolix as prescribed by their physicians. There may be a higher burden for participants in this study compared to standard of care. Patients report outcomes, in the form of questionnaires will be collected up to 24 months prospectively to assess the impact of elagolix on quality of life.

NCT ID: NCT04554602 Active, not recruiting - Endometriosis Clinical Trials

Fusion Ultrasound for Diagnosis and Monitoring of Endometriosis Lesions

ENDOFUSION
Start date: March 1, 2021
Phase:
Study type: Observational

The aim of the study is evaluate the fusion ultrasound performance compared to MRI and coelioscopy diagnosis when a surgical intervention is performed.

NCT ID: NCT04448366 Active, not recruiting - Pain Clinical Trials

Cognitive Behavioral Therapy in Endometriosis

Start date: November 24, 2020
Phase: N/A
Study type: Interventional

Endometriosis affects 10% of reproductive aged women and causes severe pain and impaired quality of life (QoL). Surgery for endometriosis results in long term symptom relief in only 40% of women. QoL in endometriosis improves after surgery, but not to the level of healthy women. Mediators in QoL include pain intensity, pain cognitions, and stress. In a preliminary study, patients with negative pain cognitions reported higher pain intensities compared to patients with positive pain cognitions. This indicates that psychological factors explain considerable variance in pain, suggesting that changing these factors by psychological interventions may contribute to improving QoL. Cognitive behavioral therapy (CBT) is proven effective as a psychological treatment for pain-related symptoms. The primary objective of this study is to investigate whether usual care combined with CBT improves QoL in patients undergoing surgery for endometriosis compared to usual care only. Secondary objectives are to investigate whether pain intensity, pain cognitions, perceived stress, fatigue and objectively measured cortisol levels mediate the effects of CBT on QoL in both groups. In a randomized controlled trial, 100 endometriosis patients undergoing surgery will be randomized between usual care with CBT (CBT group) and usual care only (control group). Women in the CBT group will receive, in addition to usual care, one pre-surgery and six post-surgery sessions of CBT, aimed at positively influencing mediators of QoL. Women in the control group will receive only usual care. Follow-up will be 7,5 months. In both groups QoL, pain intensity, pain cognitions, fatigue, perceived stress (using questionnaires) and objective stress (assessing cortisol in a hair sample) will be assessed at baseline assessment, T1 (two weeks after completion of all CBT sessions) and T2 (follow-up). Recruitment and treatment of patients will take place in Rijnstate hospital and Radboud University Medical Center (UMC).

NCT ID: NCT04445025 Active, not recruiting - Infertility Clinical Trials

Comparison Elagolix vs Depot Leuprolide Prior to Frozen Embryo Transfers in Patients With Endometriosis

Start date: September 1, 2020
Phase: Early Phase 1
Study type: Interventional

Patients who have been previously surgically diagnosed with endometriosis and have embryos predicted to be euploid after in vitro fertilization will be divided into 2 groups via randomization. The test group will receive Elagolix for 60 days prior to starting frozen embryo transfer preparation. The control group will be given leuprolide acetate every 28 days x 2 prior to starting the frozen embryo transfer preparation. Comparative implantation rates between two groups of patients will be evaluated

NCT ID: NCT04339946 Active, not recruiting - Clinical trials for Endometriosis, Rectum

Bidimensional Rectal-water Contrast-transvaginal Ultrasonography (2D-RWC-TVS) Versus 3D-RWC-TVS in the Diagnosis of Rectosigmoid Endometriosis

3Dvs2D-RWC-TVS
Start date: January 1, 2018
Phase:
Study type: Observational

An accurate diagnosis of the presence, location and extent of the rectosigmoid endometriosis is of paramount importance for the clinicians in order to inform the patients on the potential surgical or medical treatments. It is well established that transvaginal ultrasonography is the first-line investigation in patients with suspicion of deep infiltrating endometriosis. An improvement in the performance of transvaginal ultrasonography in diagnosing rectosigmoid endometriosis may be obtained by using rectal water contrast during transvaginal ultrasonographic scan.

NCT ID: NCT04204707 Active, not recruiting - Endometriosis Clinical Trials

Patient Reported Outcomes After Surgery for Rectal Endometriosis

PROCURE
Start date: December 9, 2019
Phase:
Study type: Observational

To describe the difference in patient reported outcomes after conservative treatment in comparison to radical rectal surgery in patients with deep endometriosis infiltrating the rectum (up to 15cm from the anus with at least involvement of the muscularis layer) and to determine predictors for radical surgery.

NCT ID: NCT04173169 Active, not recruiting - Infertility Clinical Trials

Pre-IVF Treatment With a GnRH Antagonist in Women With Endometriosis

PREGnant
Start date: March 15, 2022
Phase: Phase 3
Study type: Interventional

A Phase 3 clinical trial of oral GnRH antagonist pre-treatment for women with endometriosis who are undergoing IVF, with a primary outcome of live birth rate. The investigators' central hypothesis is that in infertile woman with endometriosis undergoing in vitro fertilization-embryo transfer (IVF-ET), live birth rates will improve in those pretreated with GnRH antagonist compared to those not pretreated with GnRH antagonist.