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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

117 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-14

Study Completion Date

2024-03-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain

NCT01931670

Endometriosis

COMPLETED PHASE3

Efficacy and Safety Study of Elagolix Versus Placebo or Leuprorelin Acetate in Endometriosis

NCT00797225

Endometriosis

COMPLETED PHASE2

Study Of Oral Elagolix Tablets In Combination With Combined Oral Contraceptive Capsules/Tablets To Assess Dysmenorrhea Response In Adult Female Participants With Endometriosis And Associated Moderate To Severe Pain

NCT04333576

Endometriosis

ACTIVE_NOT_RECRUITING PHASE3

An Efficacy and Safety Study of Elagolix (NBI-56418) in Women With Endometriosis

NCT00619866

Endometriosis, Pain

COMPLETED PHASE2

Global Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Women With Moderate to Severe Endometriosis-associated Pain

NCT02143713

Endometriosis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endometriosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Participants Treated With Elagolix

Participants will receive Elagolix according to the local label.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No