Efficacy and Safety of Linzagolix for the Treatment of 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: Completed

Administrative data

• NCT number: NCT03992846
• Other study ID #: 18-OBE2109-003
• Status: Completed
• Phase: Phase 3
• Start date: June 13, 2019
• Est. completion date: April 1, 2022

Study information

• Verified date: June 2022
• Source: Kissei Pharmaceutical Co., Ltd.
• 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: Completed
• Enrollment: 486
• Est. completion date: April 1, 2022
• Est. primary completion date: October 18, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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. -

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
Austria	Salzburger Landeskliniken / ID # 105	Salzburg
Austria	AKH Vienna University of Medicine Vienna / ID # 101	Vienna
Austria	AKH Vienna University of Medicine Vienna/ ID # 103	Vienna
Bulgaria	Multiprofile Hospital for Active Treatment Sliven/ ID # 131	Sliven
Bulgaria	MHAT Dr. Bratan Shukerov / ID #138	Smolyan
Bulgaria	Group Practice for Specialized Medical Assistance in GINART/ ID # 132	Sofia
Bulgaria	Medical Centre Excelsior /ID # 135	Sofia
Bulgaria	Multiprofile Hospital for Active Treatment St. Sofia/ ID # 137	Sofia
Bulgaria	University Multiprofile Hospital for Active Treatment "Sofiamed"/ ID # 133	Sofia
Czechia	MUDr Jan Drahonovsky, Ustav pro peci o matku a dite/ ID #163	Praha 4
Czechia	Gynekologicko - Porodnicka Ambulance/ ID # 162	Tábor
Czechia	Gynekologie MU Dr.Lubomir Mikulasek / ID # 160	Ujezd nad Lesy
France	CHRU Besançon Hopital/ ID # 204	Besançon
France	CHRU Strasbourg - Hopital Hautepierre/ ID # 205	Strasbourg
France	Clinique Pasteur / ID # 206	Toulouse
Hungary	Principal SMO Kft/ ID # 250	Baja	Bacs-Kiskun
Hungary	Róbert Károly Magánkórház/ ID # 253	Budapest
Hungary	Szent Anna Szuleszeti-Nogyogyaszati/ ID # 251	Debrecen
Hungary	Mediroyal Prevencios Kozpont/ ID # 252	Kecskemét
Poland	Prywatna Klinika Ginekologiczno - Poloznicza/ ID # 404	Bialystok	Podlaskie
Poland	Clinical Medical Research sp. Z o. O/ ID # 406	Katowice
Poland	Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof Wilk/ ID # 411	Katowice
Poland	Niepubliczny Zaklad Opieki Zrowotnej GynCentrum/ ID # 407	Katowice
Poland	VITA LONGA Sp. z o.o./ ID # 408	Katowice
Poland	Centrum Medyczne Chodzki Lublin/ ID # 403	Lublin
Poland	Kotarski Jan Specjalistyczny Gabinet Ginekologiczno Polozniczy/ ID # 405	Lublin
Poland	Centrum Ginekologii Endokrynologii i Medycyny Rozrodu "Artemida"/ ID # 409	Olsztyn
Poland	Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu/ ID # 410	Przemysl
Poland	Lubelskie Centrum Diagnostyczne/ ID # 402	Swidnik	Lubelskie
Poland	Specjalistyczny Gabinet Lekarski Krzysztof Dynowski / ID # 401	Warsaw
Romania	Quantum Medical Center SRL/ ID # 353	Bucharest
Romania	Spitalul Clinic "Nicolae Malaxa"/ ID # 352	Bucharest
Romania	Centrul Medical EUROMED/ ID # 351	Bucuresti
Romania	Sp Cl de Obstetrica si Ginecologie "Prof. Dr. Panait Sirbu"/ ID # 354	Bucuresti
Romania	Gine Plus SRL Cluj- Napoca/ ID # 357	Cluj-Napoca
Romania	Centrul Medical GALENUS/ ID # 355	Târgu-Mures
Spain	Hospital Regional Universitario de Málaga/ ID # 303	Málaga
Spain	Hospital General Universitario Reina Sofia/ ID # 304	Murcia
Ukraine	City clinical maternity hospital ?1/ ID # 502	Chernivtsi
Ukraine	Ivano-Frankivsk regional perinatal center, Family planning center/ ID # 506	Ivano-Frankivs'k
Ukraine	Institute of Pediatrics Obstetrics and Gynecology/ ID # 508	Kyiv
Ukraine	Kyiv City Center of Reproductive and Perinatal Medicine/ ID # 509	Kyiv
Ukraine	Kyiv City Clinical Hospital #9/ ID # 501	Kyiv
Ukraine	Kyiv City Maternity Hospital #6/ ID # 504	Kyiv
Ukraine	Medical center of LLC "Medical Center "Verum"/ ID # 503	Kyiv
Ukraine	Ternopil' Communal City Hospital #2/ ID # 511	Ternopil
Ukraine	Vinnytsia City Clinical Hospital "Center of Mother and the Child "/ ID # 510	Vinnytsia
Ukraine	Maternity Hospital ? 3/ ID # 507	Zaporizhzhya
Ukraine	Zaporizhzhya Regional Clinical Hospital/ ID # 505	Zaporizhzhya
United States	Achieve Clinical Research/ ID # 601	Birmingham	Alabama
United States	Chattanooga Medical Research LLC/ ID# 602	Chattanooga	Tennessee
United States	Southeast Clinical Research/ ID # 618	Chiefland	Florida
United States	Choice Research, LLC/ ID # 609	Dothan	Alabama
United States	Obstetrics & Gynecology Associates, Inc./ ID# 606	Fairfield	Ohio
United States	Universal Axon - Homestead, LLC/ ID # 620	Homestead	Florida
United States	Next Innovative Clinical Research/ ID # 617	Houston	Texas
United States	Multi-Specialty Research Associates, Inc./ ID # 625	Lake City	Florida
United States	The Center for Women's Health & Wellnes/ ID # 603	Lawrenceville	New Jersey
United States	Tanner Clinic/ ID # 624	Layton	Utah
United States	Wellington Anti-Aging, LLC/ ID # 613	Loxahatchee Groves	Florida
United States	Southern Clinical Research / ID # 611	Metairie	Louisiana
United States	Adventura Clinical Research/ ID # 616	Miramar	Florida
United States	Advanced Specialty Research/ ID # 610	Nampa	Idaho
United States	Affinity Clinical Research Institute/ ID # 622	Oak Brook	Illinois
United States	Quad Clinical Research LLC/ ID # 615	Saint Louis	Missouri
United States	Women's & Family Care, LLC dba GTC Research/ ID # 608	Shawnee Mission	Kansas
United States	Storks Research, LLC/ ID # 623	Sugar Land	Texas
United States	Stedman Clinical Trials/ ID # 612	Tampa	Florida
United States	Invocare Medical Research & Healthcare Center/ ID # 607	West Columbia	South Carolina
United States	PMG Research of Wilmington/ ID # 614	Wilmington	North Carolina
United States	UWCR - Lyndhurst Clinical Researc/ ID# 605	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Kissei Pharmaceutical Co., Ltd.

Countries where clinical trial is conducted

United States,  Austria,  Bulgaria,  Czechia,  France,  Hungary,  Poland,  Romania,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to Month 3
Primary	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.	Baseline to Month 3