NCT04630990

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

Effectiveness and Safety of Elagolix Treatment in Moderate to Severe Endometriosis-associated Pain in Routine Clinical Practice in Israel- ENDORSE Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 117 (actual)
• Sponsor: AbbVie · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Endometriosis

Timeline

• Start date: 2020-12-14
• Primary completion: 2024-03-26
• Completion: 2024-03-26
• First posted: 2020-11-16
• Last updated: 2025-04-01

Locations

10 sites across 1 country: Israel