Clinical trial NCT03992846: Efficacy and Safety of Linzagolix for the Treatment of 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: COMPLETED
Phase: PHASE3
Conditions: Endometriosis
Keywords: Dysmenorrhea
Dyspareunia
Dyschezia
Non-menstrual pelvic pain
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-06-20
Enrollment: 486
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: 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.

Primary outcomes:
measure: Reduction of Dysmenorrhea (DYS) at Month 3 - Proportion of Responders
timeFrame: Baseline to Month 3
measure: Reduction of Non-menstrual Pelvic Pain (NMPP) at Month 3 - Proportion of Responders
timeFrame: Baseline to Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Achieve Clinical Research/ ID # 601
state: Alabama
city: Dothan
country: United States
facility: Choice Research, LLC/ ID # 609
state: Alabama
city: Chiefland
country: United States
facility: Southeast Clinical Research/ ID # 618
state: Florida
city: Homestead
country: United States
facility: Universal Axon - Homestead, LLC/ ID # 620
state: Florida
city: Lake City
country: United States
facility: Multi-Specialty Research Associates, Inc./ ID # 625
state: Florida
city: Loxahatchee Groves
country: United States
facility: Wellington Anti-Aging, LLC/ ID # 613
state: Florida
city: Miramar
country: United States
facility: Adventura Clinical Research/ ID # 616
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials/ ID # 612
state: Florida
city: Nampa
country: United States
facility: Advanced Specialty Research/ ID # 610
state: Idaho
city: Oak Brook
country: United States
facility: Affinity Clinical Research Institute/ ID # 622
state: Illinois
city: Shawnee Mission
country: United States
facility: Women's & Family Care, LLC dba GTC Research/ ID # 608
state: Kansas
city: Metairie
country: United States
facility: Southern Clinical Research / ID # 611
state: Louisiana
city: Saint Louis
country: United States
facility: Quad Clinical Research LLC/ ID # 615
state: Missouri
city: Lawrenceville
country: United States
facility: The Center for Women's Health & Wellnes/ ID # 603
state: New Jersey
city: Wilmington
country: United States
facility: PMG Research of Wilmington/ ID # 614
state: North Carolina
city: Winston-Salem
country: United States
facility: UWCR - Lyndhurst Clinical Researc/ ID# 605
state: North Carolina
city: Fairfield
country: United States
facility: Obstetrics & Gynecology Associates, Inc./ ID# 606
state: Ohio
city: West Columbia
country: United States
facility: Invocare Medical Research & Healthcare Center/ ID # 607
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Medical Research LLC/ ID# 602
state: Tennessee
city: Houston
country: United States
facility: Next Innovative Clinical Research/ ID # 617
state: Texas
city: Sugar Land
country: United States
facility: Storks Research, LLC/ ID # 623
state: Texas
city: Layton
country: United States
facility: Tanner Clinic/ ID # 624
state: Utah
city: Salzburg
country: Austria
facility: Salzburger Landeskliniken / ID # 105
city: Vienna
country: Austria
facility: AKH Vienna University of Medicine Vienna / ID # 101
city: Vienna
country: Austria
facility: AKH Vienna University of Medicine Vienna/ ID # 103
city: Sliven
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Sliven/ ID # 131
city: Smolyan
country: Bulgaria
facility: MHAT Dr. Bratan Shukerov / ID #138
city: Sofia
country: Bulgaria
facility: Medical Centre Excelsior /ID # 135
city: Sofia
country: Bulgaria
facility: Group Practice for Specialized Medical Assistance in GINART/ ID # 132
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment St. Sofia/ ID # 137
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment "Sofiamed"/ ID # 133
city: Praha 4
country: Czechia
facility: MUDr Jan Drahonovsky, Ustav pro peci o matku a dite/ ID #163
city: Tábor
country: Czechia
facility: Gynekologicko - Porodnicka Ambulance/ ID # 162
city: Ujezd nad Lesy
country: Czechia
facility: Gynekologie MU Dr.Lubomir Mikulasek / ID # 160
city: Besançon
country: France
facility: CHRU Besançon Hopital/ ID # 204
city: Strasbourg
country: France
facility: CHRU Strasbourg - Hopital Hautepierre/ ID # 205
city: Toulouse
country: France
facility: Clinique Pasteur / ID # 206
city: Baja
country: Hungary
facility: Principal SMO Kft/ ID # 250
state: Bacs-Kiskun
city: Budapest
country: Hungary
facility: Róbert Károly Magánkórház/ ID # 253
city: Debrecen
country: Hungary
facility: Szent Anna Szuleszeti-Nogyogyaszati/ ID # 251
city: Kecskemét
country: Hungary
facility: Mediroyal Prevencios Kozpont/ ID # 252
city: Świdnik
country: Poland
facility: Lubelskie Centrum Diagnostyczne/ ID # 402
state: Lubelskie
city: Białystok
country: Poland
facility: Prywatna Klinika Ginekologiczno - Położnicza/ ID # 404
state: Podlaskie
city: Katowice
country: Poland
facility: VITA LONGA Sp. z o.o./ ID # 408
city: Katowice
country: Poland
facility: Clinical Medical Research sp. Z o. O/ ID # 406
city: Katowice
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof Wilk/ ID # 411
city: Katowice
country: Poland
facility: Niepubliczny Zaklad Opieki Zrowotnej GynCentrum/ ID # 407
city: Lublin
country: Poland
facility: Kotarski Jan Specjalistyczny Gabinet Ginekologiczno Polozniczy/ ID # 405
city: Lublin
country: Poland
facility: Centrum Medyczne Chodźki Lublin/ ID # 403
city: Olsztyn
country: Poland
facility: Centrum Ginekologii Endokrynologii i Medycyny Rozrodu "Artemida"/ ID # 409
city: Przemyśl
country: Poland
facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu/ ID # 410
city: Warsaw
country: Poland
facility: Specjalistyczny Gabinet Lekarski Krzysztof Dynowski / ID # 401
city: Bucharest
country: Romania
facility: Quantum Medical Center SRL/ ID # 353
city: Bucharest
country: Romania
facility: Spitalul Clinic "Nicolae Malaxa"/ ID # 352
city: Bucuresti
country: Romania
facility: Centrul Medical EUROMED/ ID # 351
city: Bucuresti
country: Romania
facility: Sp Cl de Obstetrica si Ginecologie "Prof. Dr. Panait Sirbu"/ ID # 354
city: Cluj-Napoca
country: Romania
facility: Gine Plus SRL Cluj- Napoca/ ID # 357
city: Târgu-Mureş
country: Romania
facility: Centrul Medical GALENUS/ ID # 355
city: Murcia
country: Spain
facility: Hospital General Universitario Reina Sofia/ ID # 304
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga/ ID # 303
city: Chernivtsi
country: Ukraine
facility: City clinical maternity hospital №1/ ID # 502
city: Ivano-Frankivs'k
country: Ukraine
facility: Ivano-Frankivsk regional perinatal center, Family planning center/ ID # 506
city: Kyiv
country: Ukraine
facility: Kyiv City Maternity Hospital #6/ ID # 504
city: Kyiv
country: Ukraine
facility: Medical center of LLC "Medical Center "Verum"/ ID # 503
city: Kyiv
country: Ukraine
facility: Institute of Pediatrics Obstetrics and Gynecology/ ID # 508
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital #9/ ID # 501
city: Kyiv
country: Ukraine
facility: Kyiv City Center of Reproductive and Perinatal Medicine/ ID # 509
city: Ternopil
country: Ukraine
facility: Ternopil' Communal City Hospital #2/ ID # 511
city: Vinnytsia
country: Ukraine
facility: Vinnytsia City Clinical Hospital "Center of Mother and the Child "/ ID # 510
city: Zaporizhzhya
country: Ukraine
facility: Zaporizhzhya Regional Clinical Hospital/ ID # 505
city: Zaporizhzhya
country: Ukraine
facility: Maternity Hospital № 3/ ID # 507
Study officials:
affiliation: ObsEva SA
name: Lecomte
role: STUDY_DIRECTOR
References: