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 Identifier
P20-399
CT.gov Identifier
NCT04630990
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
Download document(s)

Study Details

Medical Condition
  • Endometriosis
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female
    Age
    18+ years
    Inclusion and Exclusion Criteria
    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.

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Meir Medical Center /ID# 224766
    Kfar Saba, Central District, Israel, 4428164
    Status
    Not applicable
    Location
    Kaplan Medical Center /ID# 224773
    Rehovot, Central District, Israel, 7660101
    Status
    Not applicable
    Location
    Yitzhak Shamir Medical Center /ID# 224768
    Ẕerifin, Central District, Israel, 70300
    Status
    Not applicable
    Location
    Hadassah Medical Center-Hebrew University /ID# 224769
    Jerusalem, Jerusalem, Israel, 91120
    Status
    Not applicable
    Location
    Assuta Ashdod Medical Center /ID# 244898
    Ashdod, Southern District, Israel, 7747629
    Status
    Not applicable
    Location
    Soroka University Medical Center /ID# 224774
    Beersheba, Southern District, Israel, 8410101
    Status
    Not applicable
    Showing {first} - {last} of {total} Results