Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain

PHASE3TerminatedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

March 23, 2020

Primary Completion Date

January 8, 2021

Study Completion Date

February 16, 2021

Conditions
Endometriosis
Interventions
DRUG

75 mg linzagolix tablet

For oral administration once daily

DRUG

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 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

Placebo capsule to match Add-back capsule

For oral administration once daily

Trial Locations (25)

32763

A Premier Medical Research of Florida, LLC / ID # 752, Orange City

32806

Clinical Associates of Orlando, LLC / ID # 779, Orlando

33135

Coral Way Research / ID # 799, Miami

33155

La Salud Research Clinic, Inc. / ID # 824, Miami

33486

Dr. David I. Lubetkin, LLC / ID # 703, Boca Raton

37203

Clinical Research Associates Inc / ID # 802, Nashville

43213

ClinOhio Res Services, LLC / ID # 722, Columbus

Complete Healthcare for Women / ID # 801, Columbus

45005

Hilltop OBGYN / ID # 711, Franklin

48532

Onyx Clinical Research / ID # 793, Flint

48602

Valley OBGYN / ID # 704, Saginaw

60805

Providea Health Partners LLC / ID # 734, Evergreen Park

72212

Applied Res Center of Ar / Id # 735, Little Rock

75231

HCWC dba DiscoveryClinical Trials / ID # 771, Dallas

76104

Signature Gyn Services / ID # 726, Fort Worth

77450

Medical Colleagues of Texas / ID # 819, Katy

77573

Maximos OB/GYN, League City

78758

Austin Area ObGyn PLLC / ID # 701, Austin

OB/GYN North Austin / ID # 764, Austin

80111

Adv Womens Health Institute / ID # 761, Greenwood Village

80228

Red Rocks OB/GYN / ID # 732, Lakewood

84020

Physicians Research Options / ID # 766, Draper

90650

Futura Research, Inc. / ID # 781, Norwalk

T4N 6V7

CARe Clinic / ID # 872, Red Deer

00717

Puerto Rico Medical Res Inc. / ID # 890, Ponce

All Listed Sponsors
lead

Kissei Pharmaceutical Co., Ltd.

INDUSTRY