NCT04335591 - Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain (EDELWEISS 6) | Biotech Hunter

Enrollment

356

Participants

Timeline

Start Date

March 5, 2020

Primary Completion Date

September 15, 2022

Study Completion Date

December 15, 2022

Conditions

Endometriosis

Interventions

DRUG

75 mg linzagolix tablet

For oral administration once daily

DRUG

200 mg linzagolix tablet

For oral administration once daily

DRUG

Placebo tablet to match 75 mg linzagolix tablet

For oral administration once daily

DRUG

Placebo tablet to match 200 mg linzagolix tablet

For oral administration once daily

DRUG

Add-back capsule (E2 1 mg / NETA 0.5 mg)

For oral administration once daily

DRUG

Placebo capsule to match Add-back capsule

For oral administration once daily

Trial Locations (47)

1407

Medical Centre Excelsior /ID # 135, Sofia

1606

Group Practice for Specialized Medical Assistance in GINART/ ID # 132, Sofia

1797

"University Multiprofile Hospital for Active Treatment Sofiamed/ ID # 133", Sofia

5020

Salzburger Landeskliniken / ID # 105, Salzburg

8800

Multiprofile Hospital for Active Treatment Sliven/ ID # 131, Sliven

12071

Quantum Medical Center SRL/ ID # 353, Bucharest

19016

Gynekologie MU Dr.Lubomir Mikulasek / ID # 160, Újezd nad Lesy

20764

Centrul Medical EUROMED/ ID # 351, Bucharest

21019

"Vinnytsia City Clinical Hospital Center of Mother and the Child / ID # 510", Vinnytsia

22448

"Spitalul Clinic Nicolae Malaxa/ ID # 352", Bucharest

29010

Hospital Regional Universitario de Málaga/ ID # 303, Málaga

30003

Hospital General Universitario Reina Sofia/ ID # 304, Murcia

31076

Clinique Pasteur / ID # 206, Toulouse

33030

Universal Axon - Homestead, LLC/ ID # 620, Homestead

33613

Stedman Clinical Trials/ ID # 612, Tampa

36303

Choice Research, LLC/ ID # 609, Dothan

37404

Chattanooga Medical Research LLC/ ID# 602, Chattanooga

39003

Gynekologicko - Porodnicka Ambulance/ ID # 162, Tábor

46400

Ternopil' Communal City Hospital#2 / ID # 511, Ternopil

58003

City clinical maternity hospital №1/ ID # 502, Chernivtsi

60251

"Sp Cl de Obstetrica si Ginecologie Prof. Dr. Panait Sirbu/ ID # 354", Bucharest

66218

Women's & Family Care, LLC dba GTC Research/ ID # 608, Shawnee Mission

69000

Zaporizhzhya Regional Clinical Hospital/ ID # 505, Zaporizhzhya

69071

Maternity Hospital № 3/ ID # 507, Zaporizhzhya

70001

Southern Clinical Research / ID # 611, Metairie

76018

Ivano-Frankivsk regional perinatal center, Family planning center/ ID # 506, Ivano-Frankivsk

83687

Advanced Specialty Research/ ID # 610, Nampa

84041

Tanner Clinic/ ID # 624, Layton

400698

Gine Plus SRL Cluj- Napoca/ ID # 357, Cluj-Napoca

540236

Centrul Medical GALENUS/ ID # 355, Târgu Mureş

Unknown

MHAT Dr. Bratan Shukerov / ID #138, Smolyan

21-040

Lubelskie Centrum Diagnostyczne/ ID # 402, Świdnik

15-224

Prywatna Klinika Ginekologiczno - Położnicza/ ID # 404, Bialystok

40-301

Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof Wilk/ ID # 411, Katowice

40-628

Clinical Medical Research sp. Z o. O/ ID # 406, Katowice

40-851

Niepubliczny Zaklad Opieki Zrowotnej GynCentrum/ ID # 407, Katowice

20-064

Kotarski Jan Specjalistyczny Gabinet Ginekologiczno Polozniczy/ ID # 405, Lublin

20-093

Centrum Medyczne Chodźki Lublin/ ID # 403, Lublin

VITA LONGA Sp. z o.o./ ID # 408, Lublin

10-357

"Centrum Ginekologii Endokrynologii i Medycyny Rozrodu Artemida/ ID # 409", Olsztyn

37-700

Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu/ ID # 410, Przemyśl

02-929

Specjalistyczny Gabinet Lekarski Krzysztof Dynowski / ID # 401, Warsaw

02125

Kyiv City Maternity Hospital #6/ ID # 504, Kyiv

03039

"Medical center of LLC Medical Center Verum/ ID # 503", Kyiv

04050

Institute of Pediatrics Obstetrics and Gynecology/ ID # 508, Kyiv

04112

Kyiv City Clinical Hospital #9/ ID # 501, Kyiv

04210

Kyiv City Center of Reproductive and Perinatal Medicine/ ID # 509, Kyiv