Moderate to Severe Endometriosis Associated Pain MedDRA version: 19.0 Level: LLT Classification code 10014788 Term: Endometriosis related pain System Organ Class: 100000004872
Conditions
Interventions
Product Name: Elagolix-100mg
Product Code: ABT-620
Pharmaceutical Form: Tablet
INN or Proposed INN: Elagolix
CAS Number: 832720-36-2
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.) Premenopausal female, between 18 and 49 years of age, inclusive, at time of signing consent. 2.) Clinical diagnosis of endometriosis (laproscopy or laparotomy) performed within 10 years of entry into the Washout Period. 3.) Agrees to use required birth control methods during the entire length of participation in the study. 4.) Subject has a Composite Pelvic Signs and Symptoms Score total score of = 6 at Screening with a score of at least 2 for dysmenorrhea AND at least 2 for non-menstrual pelvic pain. 5.) Subjects must have at least two menstrual cycles with an interval 24-38 days within the Screening Period, prior to Day 1. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 788 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.) Subject is pregnant or breast feeding or is planning a pregnancy within the next 24 months or is less than 6 months postpartum, post-abortion, or post-pregnancy at the time of entry into the Screening Period 2.) Subject has a history of previous non-response to GnRH agonists, GnRH antagonists, Depot Medroxyprogesterone Acetate, or aromatase inhibitors as assessed by subject report of no improvement in dysmenorrhea or non-menstrual pelvic pain (subject report of partial response to or side effects from these agents is not exclusionary). 3.) Subject has chronic pelvic pain that is not caused by endometriosis that requires chronic analgesic or other chronic therapy, which would interfere with the assessment of endometriosis related pain. 4.) Clinically significant gynecological condition identified on Screening transvaginal ultrasound. 5.) Subject has a history of osteoporosis or other metabolic bone disease. 6.) Subject has a current history of undiagnosed abnormal uterine bleeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety, tolerability and efficacy of elagolix (ABT-620), administered once daily (QD) or twice daily (BID) for 3 months in the management of moderate to severe endometriosis-associated pain, and to evaluate the effect of elagolix treatment on analgesic use for endometriosis-associated pain. ;Secondary Objective: Evaluation of persistence of efficacy at 6 months, and assessments of other endometriosis-related symptoms, analgesic use, as well as quality of life (QoL) endpoints.;Primary end point(s): The co-primary efficacy endpoints will be the proportion of responders at Month 3 based upon the mutually-exclusive scales for daily assessments of DYS and NMPP measured by the modified B&B scales using the daily e-Diary;Timepoint(s) of evaluation of this end point: Month 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy variables will include assessments of the following endpoints at each post-baseline visit: DYS and NMPP, dyspareunia, analgesic use, and other patient-reported outcomes including PGIC, NRS, and EHP-30; Timepoint(s) of evaluation of this end point: Monthly, Months 1-6: All secondary efficacy variables above except EHP-30 Months 1, 3 and 6: EHP-30 | — |
Countries
Argentina, Australia, Austria, Brazil, Czech Republic, Hungary, Italy, New Zealand, Poland, Russian Federation, South Africa, Spain, United Kingdom, United States
Contacts
Public ContactEU Clinical Trials Helpdesk
AbbVie Ltd
Outcome results
None listed