The primary objective of this study is to demonstrate the efficacy and safety of linzagolix administered orally once daily for 3 months at a dose of 75 mg alone or of 200 mg in combination with add-back hormone replacement therapy (ABT: estradiol (E2) 1 mg / norethisterone acetate (NETA) 0.5 mg) versus placebo, in the management of moderate to severe endometriosis-associated pain (EAP).
This is a prospective, randomized, double-blind, placebo-controlled study to demonstrate the efficacy and safety of linzagolix administered orally once daily at doses of 75 mg alone and 200 mg in combination with low dose ABT (E2 1 mg/NETA 0.5 mg) versus placebo in the management of moderate to severe EAP in 450 women. Eligible subjects who have completed the 6-month treatment period may enter a separate extension study for 6 additional months of active treatment (no placebo control). Subjects who do not continue in the extension study will enter a 6 month treatment-free follow-up phase.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
486
For oral administration once daily
For oral administration once daily
For oral administration once daily
Reduction of Dysmenorrhea (DYS) at Month 3 - Proportion of Responders
Percentage of subjects with reduction of 1.1 for DYS in mean pelvic pain score within last 28 days prior to Month 3 or discontinuation, and stable or decreased use of analgesics for Endometriosis-associated pain (=EAP) within the same calendar days.
Time frame: Baseline to Month 3
Reduction of Non-menstrual Pelvic Pain (NMPP) at Month 3 - Proportion of Responders
Percentage of subjects with reduction of 0.8 for NMPP in mean pelvic pain score within last 28 days prior to Month 3 or discontinuation, and stable or decreased use of analgesics for Endometriosis-associated pain (=EAP) within the same calendar days.
Time frame: Baseline to Month 3
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For oral administration once daily
For oral administration once daily
For oral administration once daily
Achieve Clinical Research/ ID # 601
Birmingham, Alabama, United States
Choice Research, LLC/ ID # 609
Dothan, Alabama, United States
Southeast Clinical Research/ ID # 618
Chiefland, Florida, United States
Universal Axon - Homestead, LLC/ ID # 620
Homestead, Florida, United States
Multi-Specialty Research Associates, Inc./ ID # 625
Lake City, Florida, United States
Wellington Anti-Aging, LLC/ ID # 613
Loxahatchee Groves, Florida, United States
Adventura Clinical Research/ ID # 616
Miramar, Florida, United States
Stedman Clinical Trials/ ID # 612
Tampa, Florida, United States
Advanced Specialty Research/ ID # 610
Nampa, Idaho, United States
Affinity Clinical Research Institute/ ID # 622
Oak Brook, Illinois, United States
...and 61 more locations