A Phase 3 Study to Confirm the Efficacy and Safety of Linzagolix to Treat Endometriosis-associated Pain
- Conditions
- Endometriosis
- Interventions
- Drug: Add-back capsule (E2 1 mg / NETA 0.5 mg)Drug: Placebo capsule to match Add-back capsule
- Registration Number
- NCT03986944
- Lead Sponsor
- Kissei Pharmaceutical Co., Ltd.
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 85
The subject must have:
- Her most recent surgical and - if available - histological diagnosis of pelvic endometriosis up to 10 years before screening.
- Moderate to severe endometriosis-associated pain during the screening period.
- Regular menstrual cycles.
- BMI ≥ 18 kg/m2 at the screening visit.
Key
The subject will be excluded if she:
- Is pregnant or breast feeding or is planning a pregnancy within the duration of the treatment period of the study.
- Is less than 6 months postpartum or 3 months postabortion/ miscarriage at the time of entry into the screening period.
- Has had a surgical history of any major abdominal surgery within 6 months or any interventional surgery for endometriosis performed within a period of 2 months before screening.
- Did not respond to prior treatment with GnRH agonists or GnRH antagonists for endometriosis.
- Has a history of, or known, osteoporosis or other metabolic bone disease.
- Has chronic pelvic pain that is not caused by endometriosis and requires chronic analgesic or other chronic therapy which would interfere with the assessment of endometriosis-associated pain.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Linzagolix 200 mg + Add-back (E2 1 mg / NETA 0.5 mg) Placebo tablet to match 75 mg linzagolix tablet - Placebo Placebo tablet to match 75 mg linzagolix tablet - Placebo Placebo tablet to match 200 mg linzagolix tablet - Linzagolix 200 mg + Add-back (E2 1 mg / NETA 0.5 mg) 200 mg linzagolix tablet - Placebo Placebo capsule to match Add-back capsule - Linzagolix 75 mg Placebo tablet to match 200 mg linzagolix tablet - Linzagolix 75 mg Placebo capsule to match Add-back capsule - Linzagolix 75 mg 75 mg linzagolix tablet - Linzagolix 200 mg + Add-back (E2 1 mg / NETA 0.5 mg) Add-back capsule (E2 1 mg / NETA 0.5 mg) -
- Primary Outcome Measures
Name Time Method Dysmenorrhea Baseline to Month 3 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.Non-menstrual Pelvic Pain Baseline to Month 3 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.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (112)
CMEP/CMU health / ID # 812
🇺🇸Saginaw, Michigan, United States
Center for Women's Health / ID # 761
🇺🇸Greenwood Village, Colorado, United States
Physicians Research Options, LLC / Red Rocks Ob/Gyn / ID # 732
🇺🇸Lakewood, Colorado, United States
Visions Clinical Research-Tucson / ID # 754
🇺🇸Tucson, Arizona, United States
Join Clinical Trials / ID # 778
🇺🇸Huntington Park, California, United States
Lynn Institute of the Ozarks / ID # 826
🇺🇸Little Rock, Arkansas, United States
Mesa Obstetricians and Gyneocologists / ID # 790
🇺🇸Mesa, Arizona, United States
Synexus Clinical Research US, Inc. / ID # 725
🇺🇸Orlando, Florida, United States
Sensible Healthcare / ID # 749
🇺🇸Ocoee, Florida, United States
Praetorian Pharmaceutical Research / ID # 739
🇺🇸Marrero, Louisiana, United States
University of South Florida / ID # 738
🇺🇸Tampa, Florida, United States
Cypress Medical Research Center, LLC / ID # 755
🇺🇸Wichita, Kansas, United States
Pharmasite Research Inc / ID # 838
🇺🇸Baltimore, Maryland, United States
Universal Axon Clinical Research / ID # 769
🇺🇸Doral, Florida, United States
Futura Research, Org / ID # 781
🇺🇸Norwalk, California, United States
National Research Institute / ID # 805
🇺🇸Panorama City, California, United States
Women Under Study, LLC / ID # 820
🇺🇸New Orleans, Louisiana, United States
A Premier Medical Research of Florida, LLC / ID # 752
🇺🇸Orange City, Florida, United States
Johns Hopkins University, School Of Medicine / ID # 816
🇺🇸Baltimore, Maryland, United States
Continental Clinical Solutions, LLC / ID # 777
🇺🇸Towson, Maryland, United States
Providea Health Partners LLC / ID # 734
🇺🇸Evergreen Park, Illinois, United States
Physician Care Clinical Research LLC / ID # 810
🇺🇸Sarasota, Florida, United States
NECCR Fall River, LLC / Id # 712
🇺🇸Fall River, Massachusetts, United States
Global Health Research Center, Inc. / ID # 787
🇺🇸Miami Lakes, Florida, United States
Clinical Associates of Orlando, LLC / ID # 779
🇺🇸Orlando, Florida, United States
Carolina Medical Trials, LLC / ID # 788
🇺🇸Winston-Salem, North Carolina, United States
Women Partners in Health / ID # 836
🇺🇸Austin, Texas, United States
Accel Research Sites, DeLand Clinical Research Unit / ID # 713
🇺🇸DeLand, Florida, United States
Saginaw Valley Medical Research Group, LLC / ID # 743
🇺🇸Saginaw, Michigan, United States
Christina Sebestyen MD, P.A. dba OBGYN North / ID # 764
🇺🇸Austin, Texas, United States
Georgetown OB/GYN / ID # 770
🇺🇸Georgetown, Texas, United States
Hilltop OBGYN / ID # 711
🇺🇸Franklin, Ohio, United States
UT Southwestern Medical Center / ID # 823
🇺🇸Dallas, Texas, United States
Clinical Neuroscience Solutions, Inc. / ID # 731
🇺🇸Orlando, Florida, United States
Albuquerque Clinical Trials, Inc. / ID # 707
🇺🇸Albuquerque, New Mexico, United States
Omega Research Orlando, LLC / ID # 785
🇺🇸Orlando, Florida, United States
Valley OBGYN / ID # 704
🇺🇸Saginaw, Michigan, United States
Christus St. Elizabeth Gadolin Research, LLC / ID # 774
🇺🇸Beaumont, Texas, United States
HCWC dba DiscoveryClinical Trials / ID # 771
🇺🇸Dallas, Texas, United States
Wright State Physicians / ID # 733
🇺🇸Dayton, Ohio, United States
Austin Area ObGyn PLLC / ID # 701
🇺🇸Austin, Texas, United States
Lawrence OB/GYN clinical Research, LLC / ID # 742
🇺🇸Lawrenceville, New Jersey, United States
Carolina Institute for Clinical Research / ID # 728
🇺🇸Fayetteville, North Carolina, United States
MacArthur OB-Gyn Research / ID # 840
🇺🇸Irving, Texas, United States
FMC Science / ID # 730
🇺🇸Lampasas, Texas, United States
Penn State Health Milton S. Hershey Medical Center / ID # 804
🇺🇸Hershey, Pennsylvania, United States
WR-ClinSearch, LLC / ID # 821
🇺🇸Chattanooga, Tennessee, United States
University of Tennessee Medical Center / ID # 780
🇺🇸Knoxville, Tennessee, United States
DCT-AACT, LLC dba Discovery Clinical Trials / ID # 815
🇺🇸Pflugerville, Texas, United States
Matrix Clinical Research / ID # 751
🇺🇸Los Angeles, California, United States
Coral Way Research / ID # 799
🇺🇸Miami, Florida, United States
Suncoast Research Group, LLC / ID # 756
🇺🇸Miami, Florida, United States
Biotech Pharmaceutical Group LLC / ID # 786
🇺🇸Miami, Florida, United States
La Salud Research Clinic, Inc. / ID # 824
🇺🇸Miami, Florida, United States
Suncoast Research Associates, LLC / ID # 760
🇺🇸Miami, Florida, United States
LCC Medical Research Institute / ID # 814
🇺🇸Miami, Florida, United States
Atlanta Women's Research Institute, Inc. / ID # 727
🇺🇸Atlanta, Georgia, United States
Office of Edmond Pack, MD / Id # 818
🇺🇸Las Vegas, Nevada, United States
Complete Healthcare for Women / ID # 801
🇺🇸Columbus, Ohio, United States
Ventavia Research Group, LLC / ID # 729
🇺🇸Houston, Texas, United States
Vilo Research Group / ID # 709
🇺🇸Houston, Texas, United States
UT Health Clinical Res Ctr / ID # 828
🇺🇸Houston, Texas, United States
TMC Life Research, Inc. / ID # 809
🇺🇸Houston, Texas, United States
Seattle Reproductive Medicine / ID # 811
🇺🇸Seattle, Washington, United States
Precision Research Institute / ID # 792
🇺🇸San Diego, California, United States
MD Strategies Research Centers / ID # 765
🇺🇸San Diego, California, United States
Wasatch Clinical Research / ID # 746
🇺🇸Salt Lake City, Utah, United States
Highland Clinical Research / ID # 708
🇺🇸Salt Lake City, Utah, United States
Clinical Research Associates Inc / ID # 802
🇺🇸Nashville, Tennessee, 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
Applied Research Center of Arkansas / ID # 735
🇺🇸Little Rock, Arkansas, United States
Long Beach Clinical Trials, LLC / ID # 768
🇺🇸Long Beach, California, United States
Dr. David I. Lubetkin, LLC / ID # 703
🇺🇸Boca Raton, Florida, United States
Helix Biomedics Clincial Research, LLC / ID # 750
🇺🇸Boynton Beach, Florida, United States
Clinical Neuroscience Solutions, Inc. / ID # 773
🇺🇸Jacksonville, Florida, United States
South Florida Clinical Research Institute / ID # 747
🇺🇸Margate, Florida, United States
Sonara Clinical Research, LLC / ID # 720
🇺🇸Meridian, Idaho, United States
GCP Clinical Research, LLC / ID # 825
🇺🇸Tampa, Florida, United States
Moore Health Wellness Research Institute, LLC / ID # 795
🇺🇸Chicago, Illinois, United States
Horizon Research Group of Opelousas, LLC / ID # 757
🇺🇸Eunice, Louisiana, United States
Onyx Clinical Research / ID # 793
🇺🇸Flint, Michigan, United States
Unified Women's Clinical Research - Green Valley OBGYN / ID # 719
🇺🇸Greensboro, North Carolina, United States
Eastern Carolina Women's Center / Id # 794
🇺🇸New Bern, North Carolina, United States
ClinOhio Research Services, LLC / ID # 722
🇺🇸Columbus, Ohio, United States
Unified Women's Clinical Research - Raleigh / Id # 714
🇺🇸Raleigh, North Carolina, United States
OB/GYN Associates of Erie / ID # 706
🇺🇸Erie, Pennsylvania, United States
The Clinical Trial Center / ID # 744
🇺🇸Jenkintown, Pennsylvania, United States
VitaLink Research - Upstate / ID # 789
🇺🇸Greenville, South Carolina, United States
Clinical Trials of South Carolina / ID # 741
🇺🇸North Charleston, South Carolina, United States
VitaLink Research Spartanburg / ID # 753
🇺🇸Spartanburg, South Carolina, United States
Clinical Neuroscience Solutions, Inc / ID # 772
🇺🇸Memphis, Tennessee, United States
Signature Gyn Services / ID # 726
🇺🇸Fort Worth, Texas, United States
Medical Colleagues of Texas / ID # 819
🇺🇸Katy, Texas, United States
Maximos OB/GYN / ID # 737
🇺🇸League City, Texas, United States
DCT-McAllen Primary Care Research, LLC dba Discovery Clinical Trials / ID # 803
🇺🇸McAllen, Texas, United States
Northeast Clinical Research of San Antonio, LLC / ID # 710
🇺🇸Schertz, Texas, United States
Physicians Research Options PRO / ID # 766
🇺🇸Draper, Utah, United States
Physicians' Res Options - PG / ID # 833
🇺🇸Pleasant Grove, Utah, United States
Clinical Research Partners, LLC / ID # 715
🇺🇸Richmond, Virginia, United States
Clinical Research Partners, LLC / ID # 775
🇺🇸Richmond, Virginia, United States
Seattle Women's: Health, Research, Gynecology / ID # 702
🇺🇸Seattle, Washington, United States
CARe Clinic / ID # 872
🇨🇦Red Deer, Alberta, Canada
McMaster University Medical Centre / ID # 870
🇨🇦Hamilton, Ontario, Canada
Victory Reproductive Care / ID # 873
🇨🇦Windsor, Ontario, Canada
Ponce Medical SChool Foundation Inc./ CAIMED Center / ID # 891
🇵🇷Ponce, Puerto Rico
Puerto Rico Medical Research Inc. / ID # 890
🇵🇷Ponce, Puerto Rico
Birmingham OBGYN / ID # 740
🇺🇸Birmingham, Alabama, United States
Downtown Women's Health Care / ID # 718
🇺🇸Denver, Colorado, United States
Oregon Health & Science University / ID # 791
🇺🇸Portland, Oregon, United States
Seasons at Bristol / ID # 705
🇺🇸Bristol, Tennessee, United States
Tidewater Clinical Research The Group for Women / ID # 716
🇺🇸Virginia Beach, Virginia, United States