A Phase 3 Study to Confirm the Efficacy and Safety of Linzagolix to Treat Endometriosis-associated Pain

Endometriosis Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03986944
• Other study ID #: 18-OBE2109-002
• Status: Terminated
• Phase: Phase 3
• Start date: May 23, 2019
• Est. completion date: February 16, 2021

Study information

• Verified date: May 2022
• Source: ObsEva SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Terminated
• Enrollment: 85
• Est. completion date: February 16, 2021
• Est. primary completion date: January 6, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• 75 mg linzagolix tablet
For oral administration once daily
• 200 mg linzagolix tablet
For oral administration once daily
• Add-back capsule (E2 1 mg / NETA 0.5 mg)
For oral administration once daily
• Placebo tablet to match 75 mg linzagolix tablet
For oral administration once daily
• Placebo tablet to match 200 mg linzagolix tablet
For oral administration once daily
• Placebo capsule to match Add-back capsule
For oral administration once daily

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
ObsEva SA

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dysmenorrhea	Change at Month 3 from baseline in the mean daily assessment of dysmenorrhea measured on a Verbal Rating Scale (VRS) using an electronic diary	Baseline to Month 3
Primary	Non-menstrual pelvic pain	Change at Month 3 from baseline in the mean daily assessment of non-menstrual pelvic pain measured on a Verbal Rating Scale (VRS) using an electronic diary	Baseline to Month 3
Secondary	Dysmenorrhea	Change from baseline to Month 6 in dysmenorrhea measured on a Verbal Rating Scale (VRS) using an electronic diary	Baseline to Month 6
Secondary	Non-menstrual pelvic pain	Change from baseline to Month 6 in non-menstrual pelvic pain measured on a Verbal Rating Scale (VRS) using an electronic diary	Baseline to Month 6
Secondary	Dyschezia	Change from baseline to Month 6 in dyschezia measured on a Numeric Rating Scale (NRS) using an electronic diary	Baseline to Month 6
Secondary	Overall Pelvic Pain	Change from baseline to Month 6 in overall pelvic pain measured on a Numeric Rating Scale (NRS) using an electronic diary	Baseline to Month 6
Secondary	Interference of pain with the ability to perform daily activities	Change from baseline to Month 6 in the interference of pain with the ability to perform daily activities, measured using the pain dimension of the Endometriosis Health Profile-30 (EHP-30) using an electronic diary	Baseline to Month 6
Secondary	Dyspareunia	Change from baseline to Month 6 in dyspareunia measured on a Verbal Rating Scale (VRS) using an electronic diary	Baseline to Month 6
Secondary	No analgesic use for endometriosis associated pain	Proportion of subjects reporting no analgesic use for endometriosis associated pain, during the preceding 4-week period at Month 6	During the preceding 4-week period at Month 6
Secondary	No opiate use for endometriosis associated pain	Proportion of subjects reporting no opiate use for endometriosis associated pain, during the preceding 4-week period at Month 6	During the preceding 4-week period at Month 6
Secondary	Percentage change from baseline to Month 6 in Bone Mineral Density (BMD)	Percentage change from baseline to Month 6 of the BMD measured by dual-energy X-ray absorptiometry (DXA) scan of Lumbar Spine	Baseline to Month 6
Secondary	Change from baseline to Month 6 in Bone Mineral Density (BMD)	Change from baseline to Month 6 of the BMD measured by dual-energy X-ray absorptiometry (DXA) scan of Lumbar Spine Z-scores	Baseline to Month 6
Secondary	Clinical laboratory assessments: total cholesterol	Change from baseline to Month 6 in clinical laboratory assessments: total cholesterol	Baseline to Month 6
Secondary	Clinical laboratory assessments: LDL	Change from baseline to Month 6 in clinical laboratory assessments: LDL cholesterol	Baseline to Month 6
Secondary	Clinical laboratory assessments: triglycerides	Change from baseline to Month 6 in clinical laboratory assessments: Triglycerides	Baseline to Month 6
Secondary	Change from baseline to Month 6 in the endometrial thickness	Change from baseline to Month 6 in endometrial thickness measured by Transvaginal Ultrasound (TVUS)	Baseline to Month 6
Secondary	Change From Baseline to Month 6 in ECG results	Change from baseline to Month 6 in ECG results (QTcF values)	Baseline to Month 6