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Endometriosis clinical trials

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NCT ID: NCT05568940 Withdrawn - Endometriosis Clinical Trials

Evaluating Tibolone Add-back in Patients With Endometriosis and Fibroids

eTAPE
Start date: September 2024
Phase:
Study type: Observational

While there are many medical options for managing endometriosis and fibroids, GnRH-agonist (GnRH-a) therapy remains a very common method of treating these complex conditions. Although this therapy is effective, it does come with significant menopausal side effects, such as hot flashes, sweating, mood changes, sleep disturbance, altered sex drive, decreased bone density, and vaginal and urinary symptoms. In short, chemically-induced menopause (menopause triggered by GnRH-a injection) causes the same symptoms of natural menopause, but with a sudden onset in a generally young and active population. Low dose hormone add-back therapy is commonly used to lessen these side effects of GnRH-a use. There are many menopausal hormone therapies (MHTs) used in menopausal women that can help, but few studies have directly evaluated the different options of treatment for women undergoing chemically-induced menopause. Tibolone is a menopausal hormone therapy (MHT) that stands out as a good option in the management of medical menopause in endometriosis patients because it may give fewer side effects than other alternatives and have a positive effect on mood and libido. This study aims to see how effective Tibolone is as an add-back therapy in women who are hormonally suppressed with a GnRH-a. For this study, we will recruit pre-menopausal women over the age of 18 years old undergoing therapy with the GnRH-a Lupron.

NCT ID: NCT04955574 Withdrawn - Endometriosis Clinical Trials

Probiotic and Antibiotic Therapies in Women With Unexplained Infertility

Start date: January 2023
Phase: Phase 2
Study type: Interventional

The study is designed as a proof of concept pilot study with 3 study arms to evaluate the safety and feasibility of the use of oral probiotics and/or antibiotics in women with unexplained infertility/endometriosis. Our secondary outcomes will assess In Vitro Fertilization outcomes, and changes in the uterine microbiota (bacteria), intestinal barrier integrity, and urinary metabolites in response to study interventions.

NCT ID: NCT04347135 Withdrawn - Endometriosis Clinical Trials

Evaluating Endometriosis With 16α-(18)F-fluoro-17β-estradiol ([F-18] FES) PET/MRI

Start date: October 7, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

Researchers are trying to improve the detection of endometriosis using F-18 FES PET/MRI imaging.

NCT ID: NCT04184323 Withdrawn - Endometriosis Clinical Trials

SIRT-1 Antagonism for Endometrial Receptivity

SAFER
Start date: January 2022
Phase: Phase 2
Study type: Interventional

Progesterone resistance is mediated through epigenetic modification through SirT1 activation and is thought to contribute to infertility and progression of endometriosis. Endometriosis is a leading cause of unexplained IVF failure secondary to inflammatory changes that induce SirT1. The current study is designed to investigate a small molecule inhibitor of SirT1, in the clinical setting of In Vitro Fertilization and Embryo Transfer. The SAFER trial will compare EX-527 to placebo in a randomized, double-blind trial. Primary endpoints include Live Birth Rate (LBR) and secondary outcomes include pregnancy rate (PR), miscarriage rate (MR) and implantation failure rate.

NCT ID: NCT04174911 Withdrawn - Endometriosis Clinical Trials

A Study to Evaluate the Safety and Efficacy of BOL-DP-o-08 in Patients With Endometriosis Syndrome.

Start date: January 2019
Phase: Phase 1/Phase 2
Study type: Interventional

A Phase 2a, Single-center, randomized, double-blind, placebo-controlled study, in 80 subjects diagnosed with Endometriosis, stage 2-4

NCT ID: NCT04118777 Withdrawn - Endometriosis Clinical Trials

Postoperative Narcotic Use After Laparoscopic Gynecologic Surgery

Start date: May 1, 2020
Phase: N/A
Study type: Interventional

This will be a prospective, randomized, double blinded placebo-controlled study at Erlanger hospital. Eligible patients who provide consent will be randomized into one of two arms receiving continuous intra-peritoneal local anesthetic with 0.2% Ropivacaine or saline.

NCT ID: NCT03884400 Withdrawn - Healthy Clinical Trials

Distribution of Biospecimens From Biorepositories/Biobanks for Research Use

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

This protocol seeks to assist biorepositories/biobanks in distributing their stored specimens and data to researchers that will actually utilize them to advance medicine and technology.

NCT ID: NCT03481842 Withdrawn - Endometriosis Clinical Trials

Safety, Tolerability and Efficacy of Vaginal Suppositories for Treatment of the Endometriosis

ELTA
Start date: October 10, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Background: Endometriosis is a chronic gynecological disease with the growth of endometrial tissue outside the endometrium. In all its properties, this tissue is similar to the mucous membrane of the uterus. Types of endometriosis: Endometriosis is divided into genital and extragenital. Genital endometriosis is internal and external. When the inner is affected by the uterus, with the external - the ovaries, tubes, vagina and external genital organs are affected. Extragenital endometriosis can affect various organs of the abdominal cavity. Drug treatment does not show high effectiveness. Surgery / laparoscopic is currently considered the gold standard treatment for this problem, including infertility treatment. The purpose of our studies is to achieve substantial results with respect to tolerability, safety and clinical efficacy of vaginal suppository ELTA for treatment of the endometriosis. Methods: Phase I clinical trial to be conducted at Cancer Center to hold under the aegis UniversitätsSpital Zürich from May 2018 to September 2018. Ninety-four patients with the form of genital endometriosis will take part in the studies. The study was approved by the Ethics Committee at the Cancer Institute no C99884.01FH339

NCT ID: NCT03272360 Withdrawn - Endometriosis Clinical Trials

Endometriosis Biomarker Discovery Study

EMBARK
Start date: September 2016
Phase: N/A
Study type: Observational

This is a prospective, Single time point, discovery study intending to identify biomarkers that can differentiate endometriosis from other underlying reasons for pelvic pain. Patients undergoing laparoscopy for evaluation of chronic pelvic pain or elective tubal ligation will be enrolled for collection of tissue samples at the time of laparoscopy.

NCT ID: NCT02728245 Withdrawn - Endometriosis Clinical Trials

Trial Comparing Preoperative Dienogest Therapy Followed by Surgery vs. Upfront Surgery to Save Ovarian Reserve in Young Women With Ovarian Endometrioma

DOROSY
Start date: October 2017
Phase: Phase 2
Study type: Interventional

Randomized phase 2 trial comparing preoperative dienogest therapy followed by surgery vs. upfront surgery to save ovarian reserve in young women with ovarian endometrioma