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
85
For oral administration once daily
For oral administration once daily
For oral administration once daily
Dysmenorrhea
Change at Month 3 from baseline in the mean daily assessment of dysmenorrhea (DYS) measured on a 4-point Verbal Rating Scale (VRS) using an electronicdiary * The 4-point VRS scale for DYS ranges from 0 to 3 (0: No pain; 1: Mild pain; 2: Moderate pain; 3: Severe pain). * A negative change in scores would be indicative of an improvement in the pain of DYS.
Time frame: Baseline to Month 3
Non-menstrual Pelvic Pain
Change at Month 3 from baseline in the mean daily assessment of non-menstrual pelvic pain (NMPP) measured on a 4-point Verbal Rating Scale (VRS) using anelectronic diary * The 4-point VRS scale for NMPP ranges from 0 to 3 (0: No pain; 1: Mild pain; 2: Moderate pain; 3: Severe pain). * A negative change in scores would be indicative of an improvement in the NMPP.
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
Birmingham OBGYN / ID # 740
Birmingham, Alabama, United States
Mesa Obstetricians and Gyneocologists / ID # 790
Mesa, Arizona, United States
Precision Trials AZ, LLC / ID # 783
Phoenix, Arizona, United States
Quality of LIfe Medical & Research Center, LLC / ID # 813
Tucson, Arizona, United States
Visions Clinical Research-Tucson / ID # 754
Tucson, Arizona, United States
Lynn Institute of the Ozarks / ID # 826
Little Rock, Arkansas, United States
Applied Research Center of Arkansas / ID # 735
Little Rock, Arkansas, United States
Join Clinical Trials / ID # 778
Huntington Park, California, United States
Long Beach Clinical Trials, LLC / ID # 768
Long Beach, California, United States
Matrix Clinical Research / ID # 751
Los Angeles, California, United States
...and 102 more locations