NCT04630990Completed
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
Source: ClinicalTrials.gov · Last updated 1 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 117 (actual)
- First submitted
- 29 Oct 2020
- Start date
- 14 Dec 2020
- Primary completion date
- 26 Mar 2024
- Lead sponsor
- AbbVie
- Diseases
- Endometriosis
- NCT number
- NCT04630990
What you commit to
- Study type: Observational
- Participants enrolled: 117
- From 14 Dec 2020 to the primary completion date, 26 Mar 2024
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in a concurrent interventional clinical trial.
Other
- Contraindication to the use of elagolix.
- Post-menopausal (naturally or surgically).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Assuta Ashdod Medical Center /ID# 244898 Coordinator of this site? Confirm its status | Ashdod | Israel | Unknown status |
| Soroka University Medical Center /ID# 224774 Coordinator of this site? Confirm its status | Beersheba | Israel | Unknown status |
| Clalit Health Services /ID# 224771 Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Hadassah Medical Center-Hebrew University /ID# 224769 Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Meir Medical Center /ID# 224766 Coordinator of this site? Confirm its status | Kfar Saba | Israel | Unknown status |
| The Chaim Sheba Medical Center /ID# 224764 Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Kaplan Medical Center /ID# 224773 Coordinator of this site? Confirm its status | Rehovot | Israel | Unknown status |
| Tel Aviv Sourasky Medical Center /ID# 224765 Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Maccabi Health Services /ID# 224775 Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Yitzhak Shamir Medical Center /ID# 224768 Coordinator of this site? Confirm its status | Tsrifin | Israel | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.