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)
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About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Diagnosed with endometriosis and experiencing Dysmenorrhea (DYS).
- Naïve to elagolix prior to starting this study or have stopped taking elagolix for 2 months prior to study enrollment.
- Prescribed elagolix as part of standard treatment for endometriosis, according to the local label.
Exclusion criteria
- Contraindication to the use of elagolix.
- Post-menopausal (naturally or surgically).
- Participation in a concurrent interventional clinical trial.
Trial design
117 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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