486
Participants
Start Date
June 13, 2019
Primary Completion Date
October 18, 2021
Study Completion Date
April 1, 2022
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
AKH Vienna University of Medicine Vienna / ID # 101, Vienna
AKH Vienna University of Medicine Vienna/ ID # 103, Vienna
Róbert Károly Magánkórház/ ID # 253, Budapest
Medical Centre Excelsior /ID # 135, Sofia
Group Practice for Specialized Medical Assistance in GINART/ ID # 132, Sofia
Multiprofile Hospital for Active Treatment St. Sofia/ ID # 137, Sofia
"University Multiprofile Hospital for Active Treatment Sofiamed/ ID # 133", Sofia
Szent Anna Szuleszeti-Nogyogyaszati/ ID # 251, Debrecen
Salzburger Landeskliniken / ID # 105, Salzburg
Mediroyal Prevencios Kozpont/ ID # 252, Kecskemét
Principal SMO Kft/ ID # 250, Baja
Multiprofile Hospital for Active Treatment Sliven/ ID # 131, Sliven
Quantum Medical Center SRL/ ID # 353, Bucharest
MUDr Jan Drahonovsky, Ustav pro peci o matku a dite/ ID #163, Prague
Gynekologie MU Dr.Lubomir Mikulasek / ID # 160, Újezd nad Lesy
Centrul Medical EUROMED/ ID # 351, Bucharest
"Vinnytsia City Clinical Hospital Center of Mother and the Child / ID # 510", Vinnytsia
"Spitalul Clinic Nicolae Malaxa/ ID # 352", Bucharest
CHRU Besançon Hopital/ ID # 204, Besançon
UWCR - Lyndhurst Clinical Researc/ ID# 605, Winston-Salem
PMG Research of Wilmington/ ID # 614, Wilmington
Hospital Regional Universitario de Málaga/ ID # 303, Málaga
Invocare Medical Research & Healthcare Center/ ID # 607, West Columbia
Hospital General Universitario Reina Sofia/ ID # 304, Murcia
Clinique Pasteur / ID # 206, Toulouse
Multi-Specialty Research Associates, Inc./ ID # 625, Lake City
Southeast Clinical Research/ ID # 618, Chiefland
Adventura Clinical Research/ ID # 616, Miramar
Universal Axon - Homestead, LLC/ ID # 620, Homestead
Wellington Anti-Aging, LLC/ ID # 613, Loxahatchee Groves
Stedman Clinical Trials/ ID # 612, Tampa
Achieve Clinical Research/ ID # 601, Birmingham
Choice Research, LLC/ ID # 609, Dothan
Chattanooga Medical Research LLC/ ID# 602, Chattanooga
Gynekologicko - Porodnicka Ambulance/ ID # 162, Tábor
Obstetrics & Gynecology Associates, Inc./ ID# 606, Fairfield
Ternopil' Communal City Hospital #2/ ID # 511, Ternopil
City clinical maternity hospital №1/ ID # 502, Chernivtsi
"Sp Cl de Obstetrica si Ginecologie Prof. Dr. Panait Sirbu/ ID # 354", Bucharest
Affinity Clinical Research Institute/ ID # 622, Oak Brook
Quad Clinical Research LLC/ ID # 615, St Louis
Women's & Family Care, LLC dba GTC Research/ ID # 608, Shawnee Mission
CHRU Strasbourg - Hopital Hautepierre/ ID # 205, Strasbourg
Zaporizhzhya Regional Clinical Hospital/ ID # 505, Zaporizhzhya
Maternity Hospital № 3/ ID # 507, Zaporizhzhya
Southern Clinical Research / ID # 611, Metairie
Ivano-Frankivsk regional perinatal center, Family planning center/ ID # 506, Ivano-Frankivsk
Next Innovative Clinical Research/ ID # 617, Houston
Storks Research, LLC/ ID # 623, Sugar Land
Advanced Specialty Research/ ID # 610, Nampa
Tanner Clinic/ ID # 624, Layton
Gine Plus SRL Cluj- Napoca/ ID # 357, Cluj-Napoca
Centrul Medical GALENUS/ ID # 355, Târgu Mureş
The Center for Women's Health & Wellnes/ ID # 603, Lawrenceville
MHAT Dr. Bratan Shukerov / ID #138, Smolyan
Lubelskie Centrum Diagnostyczne/ ID # 402, Świdnik
Prywatna Klinika Ginekologiczno - Położnicza/ ID # 404, Bialystok
VITA LONGA Sp. z o.o./ ID # 408, Katowice
Centrum Medyczne Chodźki Lublin/ ID # 403, Lublin
Clinical Medical Research sp. Z o. O/ ID # 406, Katowice
Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof Wilk/ ID # 411, Katowice
Niepubliczny Zaklad Opieki Zrowotnej GynCentrum/ ID # 407, Katowice
Kotarski Jan Specjalistyczny Gabinet Ginekologiczno Polozniczy/ ID # 405, Lublin
"Centrum Ginekologii Endokrynologii i Medycyny Rozrodu Artemida/ ID # 409", Olsztyn
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu/ ID # 410, Przemyśl
Specjalistyczny Gabinet Lekarski Krzysztof Dynowski / ID # 401, Warsaw
Kyiv City Maternity Hospital #6/ ID # 504, Kyiv
"Medical center of LLC Medical Center Verum/ ID # 503", Kyiv
Institute of Pediatrics Obstetrics and Gynecology/ ID # 508, Kyiv
Kyiv City Clinical Hospital #9/ ID # 501, Kyiv
Kyiv City Center of Reproductive and Perinatal Medicine/ ID # 509, Kyiv
Lead Sponsor
Kissei Pharmaceutical Co., Ltd.
INDUSTRY