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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
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

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Assuta Ashdod Medical Center /ID# 244898
Coordinator of this site? Confirm its status
AshdodIsraelUnknown status
Soroka University Medical Center /ID# 224774
Coordinator of this site? Confirm its status
BeershebaIsraelUnknown status
Clalit Health Services /ID# 224771
Coordinator of this site? Confirm its status
HaifaIsraelUnknown status
Hadassah Medical Center-Hebrew University /ID# 224769
Coordinator of this site? Confirm its status
JerusalemIsraelUnknown status
Meir Medical Center /ID# 224766
Coordinator of this site? Confirm its status
Kfar SabaIsraelUnknown status
The Chaim Sheba Medical Center /ID# 224764
Coordinator of this site? Confirm its status
Ramat GanIsraelUnknown status
Kaplan Medical Center /ID# 224773
Coordinator of this site? Confirm its status
RehovotIsraelUnknown status
Tel Aviv Sourasky Medical Center /ID# 224765
Coordinator of this site? Confirm its status
Tel AvivIsraelUnknown status
Maccabi Health Services /ID# 224775
Coordinator of this site? Confirm its status
Tel AvivIsraelUnknown status
Yitzhak Shamir Medical Center /ID# 224768
Coordinator of this site? Confirm its status
TsrifinIsraelUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.