The purpose of this study is to assess safety and efficacy of BAY 1817080 compared to elagolix and placebo in women with symptomatic endometriosis. Study details include: * Study duration: 155 up to 285 days * Treatment duration: 84 days * Visit frequency: 3 laboratory every 2 weeks for participants on BAY 1817080 or placebo
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
215
Tablet, oral administration
Tablet, oral administration
Tablet, oral administration
Accel Research Sites - Cahaba Medical Care
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Mobile Ob-Gyn, PC
Mobile, Alabama, United States
Precision Trials, AZ, LLC
Phoenix, Arizona, United States
Diagnamics, Inc.
Encinitas, California, United States
Absolute Change in Mean Worst Endometriosis Associated Pelvic Pain (EAPP), Primary Per Protocol Set (pPPS)
The worst EAPP was measured daily on the 0-10 Numerical Rating Scale (NRS) by item 1 of the Endometriosis Symptom Diary (ESD). In question 1, participants were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The absolute change in mean worst EAPP was from baseline (last 28 days before the first intake of study drug) to end of intervention (last 28 days ending with the last intake of study drug planned on Day 84 \[+3\]). The time frame of 28 days captures a menstrual cycle on average.
Time frame: change from baseline to week 12
Least Squares Mean (SE) Changes in Worst EAPP From Baseline to Week 12, Per Protocol Set
The worst EAPP was measured daily on the 0-10 Numerical Rating Scale (NRS) by item 1 of the Endometriosis Symptom Diary (ESD). In question 1, participants were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The absolute change in mean worst EAPP was from baseline (last 28 days before the first intake of study drug) to end of intervention (last 28 days ending with the last intake of study drug planned on Day 84 \[+3\]). The time frame of 28 days captures a menstrual cycle on average.
Time frame: change from baseline to week 12
Number of Participants With Treatment-emergent Adverse Events (TEAE)
A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Time frame: up to 14 days after the last study medication intake
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West Coast OB/GYN Associates
San Diego, California, United States
Advanced Women's Health Institute
Greenwood Village, Colorado, United States
Office of Dr. James A. Simon, MD
Washington D.C., District of Columbia, United States
Helix Biomedics, LLC
Boynton Beach, Florida, United States
Alliance for Multispecialty Research, LLC - Fort Meyers
Fort Myers, Florida, United States
...and 137 more locations