Clinical trial NCT03986944: A Phase 3 Study to Confirm the Efficacy and Safety of Linzagolix to Treat Endometriosis-associated Pain
Official title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled, Clinical Study to Assess the Efficacy and Safety of Linzagolix in Subjects With Moderate to Severe Endometriosis-associated Pain.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Endometriosis
Keywords: Dysmenorrhea
Dyspareunia
Dyschezia
Non-menstrual pelvic pain
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-06-14
Enrollment: 85
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Key Inclusion Criteria:

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 Exclusion Criteria:

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.

Primary outcomes:
measure: Dysmenorrhea
timeFrame: Baseline to Month 3
measure: Non-menstrual Pelvic Pain
timeFrame: Baseline to Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham OBGYN / ID # 740
state: Alabama
city: Mesa
country: United States
facility: Mesa Obstetricians and Gyneocologists / ID # 790
state: Arizona
city: Phoenix
country: United States
facility: Precision Trials AZ, LLC / ID # 783
state: Arizona
city: Tucson
country: United States
facility: Quality of LIfe Medical & Research Center, LLC / ID # 813
state: Arizona
city: Tucson
country: United States
facility: Visions Clinical Research-Tucson / ID # 754
state: Arizona
city: Little Rock
country: United States
facility: Lynn Institute of the Ozarks / ID # 826
state: Arkansas
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas / ID # 735
state: Arkansas
city: Huntington Park
country: United States
facility: Join Clinical Trials / ID # 778
state: California
city: Long Beach
country: United States
facility: Long Beach Clinical Trials, LLC / ID # 768
state: California
city: Los Angeles
country: United States
facility: Matrix Clinical Research / ID # 751
state: California
city: Norwalk
country: United States
facility: Futura Research, Org / ID # 781
state: California
city: Panorama City
country: United States
facility: National Research Institute / ID # 805
state: California
city: San Diego
country: United States
facility: Precision Research Institute / ID # 792
state: California
city: San Diego
country: United States
facility: MD Strategies Research Centers / ID # 765
state: California
city: Denver
country: United States
facility: Downtown Women's Health Care / ID # 718
state: Colorado
city: Greenwood Village
country: United States
facility: Center for Women's Health / ID # 761
state: Colorado
city: Lakewood
country: United States
facility: Physicians Research Options, LLC / Red Rocks Ob/Gyn / ID # 732
state: Colorado
city: Boca Raton
country: United States
facility: Dr. David I. Lubetkin, LLC / ID # 703
state: Florida
city: Boynton Beach
country: United States
facility: Helix Biomedics Clincial Research, LLC / ID # 750
state: Florida
city: DeLand
country: United States
facility: Accel Research Sites, DeLand Clinical Research Unit / ID # 713
state: Florida
city: Doral
country: United States
facility: Universal Axon Clinical Research / ID # 769
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc. / ID # 773
state: Florida
city: Margate
country: United States
facility: South Florida Clinical Research Institute / ID # 747
state: Florida
city: Miami Lakes
country: United States
facility: Global Health Research Center, Inc. / ID # 787
state: Florida
city: Miami
country: United States
facility: Coral Way Research / ID # 799
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group, LLC / ID # 756
state: Florida
city: Miami
country: United States
facility: Biotech Pharmaceutical Group LLC / ID # 786
state: Florida
city: Miami
country: United States
facility: La Salud Research Clinic, Inc. / ID # 824
state: Florida
city: Miami
country: United States
facility: Suncoast Research Associates, LLC / ID # 760
state: Florida
city: Miami
country: United States
facility: LCC Medical Research Institute / ID # 814
state: Florida
city: Ocoee
country: United States
facility: Sensible Healthcare / ID # 749
state: Florida
city: Orange City
country: United States
facility: A Premier Medical Research of Florida, LLC / ID # 752
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc. / ID # 731
state: Florida
city: Orlando
country: United States
facility: Omega Research Orlando, LLC / ID # 785
state: Florida
city: Orlando
country: United States
facility: Clinical Associates of Orlando, LLC / ID # 779
state: Florida
city: Orlando
country: United States
facility: Synexus Clinical Research US, Inc. / ID # 725
state: Florida
city: Sarasota
country: United States
facility: Physician Care Clinical Research LLC / ID # 810
state: Florida
city: Tampa
country: United States
facility: University of South Florida / ID # 738
state: Florida
city: Tampa
country: United States
facility: GCP Clinical Research, LLC / ID # 825
state: Florida
city: Atlanta
country: United States
facility: Atlanta Women's Research Institute, Inc. / ID # 727
state: Georgia
city: Meridian
country: United States
facility: Sonara Clinical Research, LLC / ID # 720
state: Idaho
city: Chicago
country: United States
facility: Moore Health Wellness Research Institute, LLC / ID # 795
state: Illinois
city: Evergreen Park
country: United States
facility: Providea Health Partners LLC / ID # 734
state: Illinois
city: Wichita
country: United States
facility: Cypress Medical Research Center, LLC / ID # 755
state: Kansas
city: Eunice
country: United States
facility: Horizon Research Group of Opelousas, LLC / ID # 757
state: Louisiana
city: Marrero
country: United States
facility: Praetorian Pharmaceutical Research / ID # 739
state: Louisiana
city: New Orleans
country: United States
facility: Women Under Study, LLC / ID # 820
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University, School Of Medicine / ID # 816
state: Maryland
city: Baltimore
country: United States
facility: Pharmasite Research Inc / ID # 838
state: Maryland
city: Towson
country: United States
facility: Continental Clinical Solutions, LLC / ID # 777
state: Maryland
city: Fall River
country: United States
facility: NECCR Fall River, LLC / Id # 712
state: Massachusetts
city: Flint
country: United States
facility: Onyx Clinical Research / ID # 793
state: Michigan
city: Saginaw
country: United States
facility: CMEP/CMU health / ID # 812
state: Michigan
city: Saginaw
country: United States
facility: Valley OBGYN / ID # 704
state: Michigan
city: Saginaw
country: United States
facility: Saginaw Valley Medical Research Group, LLC / ID # 743
state: Michigan
city: Las Vegas
country: United States
facility: Office of Edmond Pack, MD / Id # 818
state: Nevada
city: Lawrenceville
country: United States
facility: Lawrence OB/GYN clinical Research, LLC / ID # 742
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc. / ID # 707
state: New Mexico
city: Fayetteville
country: United States
facility: Carolina Institute for Clinical Research / ID # 728
state: North Carolina
city: Greensboro
country: United States
facility: Unified Women's Clinical Research - Green Valley OBGYN / ID # 719
state: North Carolina
city: New Bern
country: United States
facility: Eastern Carolina Women's Center / Id # 794
state: North Carolina
city: Raleigh
country: United States
facility: Unified Women's Clinical Research - Raleigh / Id # 714
state: North Carolina
city: Winston-Salem
country: United States
facility: Carolina Medical Trials, LLC / ID # 788
state: North Carolina
city: Columbus
country: United States
facility: ClinOhio Research Services, LLC / ID # 722
state: Ohio
city: Columbus
country: United States
facility: Complete Healthcare for Women / ID # 801
state: Ohio
city: Dayton
country: United States
facility: Wright State Physicians / ID # 733
state: Ohio
city: Franklin
country: United States
facility: Hilltop OBGYN / ID # 711
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University / ID # 791
state: Oregon
city: Erie
country: United States
facility: OB/GYN Associates of Erie / ID # 706
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Health Milton S. Hershey Medical Center / ID # 804
state: Pennsylvania
city: Jenkintown
country: United States
facility: The Clinical Trial Center / ID # 744
state: Pennsylvania
city: Greenville
country: United States
facility: VitaLink Research - Upstate / ID # 789
state: South Carolina
city: North Charleston
country: United States
facility: Clinical Trials of South Carolina / ID # 741
state: South Carolina
city: Spartanburg
country: United States
facility: VitaLink Research Spartanburg / ID # 753
state: South Carolina
city: Bristol
country: United States
facility: Seasons at Bristol / ID # 705
state: Tennessee
city: Chattanooga
country: United States
facility: WR-ClinSearch, LLC / ID # 821
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennessee Medical Center / ID # 780
state: Tennessee
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc / ID # 772
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates Inc / ID # 802
state: Tennessee
city: Austin
country: United States
facility: Women Partners in Health / ID # 836
state: Texas
city: Austin
country: United States
facility: Austin Area ObGyn PLLC / ID # 701
state: Texas
city: Austin
country: United States
facility: Christina Sebestyen MD, P.A. dba OBGYN North / ID # 764
state: Texas
city: Beaumont
country: United States
facility: Christus St. Elizabeth Gadolin Research, LLC / ID # 774
state: Texas
city: Dallas
country: United States
facility: HCWC dba DiscoveryClinical Trials / ID # 771
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center / ID # 823
state: Texas
city: Fort Worth
country: United States
facility: Signature Gyn Services / ID # 726
state: Texas
city: Georgetown
country: United States
facility: Georgetown OB/GYN / ID # 770
state: Texas
city: Houston
country: United States
facility: Ventavia Research Group, LLC / ID # 729
state: Texas
city: Houston
country: United States
facility: Vilo Research Group / ID # 709
state: Texas
city: Houston
country: United States
facility: UT Health Clinical Res Ctr / ID # 828
state: Texas
city: Houston
country: United States
facility: TMC Life Research, Inc. / ID # 809
state: Texas
city: Irving
country: United States
facility: MacArthur OB-Gyn Research / ID # 840
state: Texas
city: Katy
country: United States
facility: Medical Colleagues of Texas / ID # 819
state: Texas
city: Lampasas
country: United States
facility: FMC Science / ID # 730
state: Texas
city: League City
country: United States
facility: Maximos OB/GYN / ID # 737
state: Texas
city: McAllen
country: United States
facility: DCT-McAllen Primary Care Research, LLC dba Discovery Clinical Trials / ID # 803
state: Texas
city: Pflugerville
country: United States
facility: DCT-AACT, LLC dba Discovery Clinical Trials / ID # 815
state: Texas
city: Schertz
country: United States
facility: Northeast Clinical Research of San Antonio, LLC / ID # 710
state: Texas
city: Draper
country: United States
facility: Physicians Research Options PRO / ID # 766
state: Utah
city: Pleasant Grove
country: United States
facility: Physicians' Res Options - PG / ID # 833
state: Utah
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research / ID # 746
state: Utah
city: Salt Lake City
country: United States
facility: Highland Clinical Research / ID # 708
state: Utah
city: Richmond
country: United States
facility: Clinical Research Partners, LLC / ID # 715
state: Virginia
city: Richmond
country: United States
facility: Clinical Research Partners, LLC / ID # 775
state: Virginia
city: Virginia Beach
country: United States
facility: Tidewater Clinical Research The Group for Women / ID # 716
state: Virginia
city: Seattle
country: United States
facility: Seattle Women's: Health, Research, Gynecology / ID # 702
state: Washington
city: Seattle
country: United States
facility: Seattle Reproductive Medicine / ID # 811
state: Washington
city: Red Deer
country: Canada
facility: CARe Clinic / ID # 872
state: Alberta
city: Hamilton
country: Canada
facility: McMaster University Medical Centre / ID # 870
state: Ontario
city: Windsor
country: Canada
facility: Victory Reproductive Care / ID # 873
state: Ontario
city: Ponce
country: Puerto Rico
facility: Ponce Medical SChool Foundation Inc./ CAIMED Center / ID # 891
city: Ponce
country: Puerto Rico
facility: Puerto Rico Medical Research Inc. / ID # 890
Study officials:
affiliation: ObsEva SA
name: Lecomte
role: STUDY_DIRECTOR
References: