Clinical trial NCT04372121: Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain
Official title: A Double-blind Randomized Extension Study to Assess the Long-term Efficacy and Safety of Linzagolix in Subjects With Endometriosis-associated Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Endometriosis
Keywords: Dysmenorrhea
Dyspareunia
Dyschezia
Non-menstrual pelvic pain
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-05-01
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this extension study is to assess the maintenance of efficacy of linzagolix administered orally once daily for up to an additional 6 months (for up to 12 months of treatment in total) in women who have already completed 6 months of linzagolix treatment at a dose of 75 mg alone or of 200 mg in combination with ABT (E2 1 mg / NETA 0.5 mg), in the management of moderate to severe endometriosis-associated pain (EAP) in women with surgically confirmed endometriosis.

Detailed description: This is a prospective, randomized, double-blind study. Subjects who have completed the 6-month Treatment Period in 18-OBE2109-002 - Edelweiss 2 study (herein referred to as main study) will be invited to enter the present extension study. Month 6 visit of the main study is a decision point for Subjects to either end treatment and enter a post-treatment follow up (part of the main study), or to opt for a 6-month treatment extension. All subjects will receive once daily either linzagolix 75 mg alone (with ABT placebo) or 200 mg combined with ABT for 6 months. Subjects who received placebo during the main study will be randomized to either linzagolix 75 mg alone (with ABT placebo) or linzagolix 200 mg with ABT. Subjects who received active treatment during the main study will continue with the same treatment. Double-dummy design will be used in order to maintain the blinding of the study.

After end of treatment in the extension study (6-month treatment period: from Month 6 to Month 12), subjects will enter a post-treatment Follow-Up Period of 6 months with no investigational medicinal product (IMP) or - for subjects willing to continue treatment - a second extension study will be proposed.

Eligibility criteria: Inclusion Criteria:

The subject must have:

* completed the 6-month treatment in the main study
* agreed to continue to use only the analgesic rescue medication permitted by the protocol during the Treatment and Follow-up Periods
* agreed to continue to comply with the requirements of the study protocol for the duration of the extension study

Exclusion Criteria:

The subject will be excluded if she:

* is pregnant or breast feeding or is planning a pregnancy within the duration of the of the study (including the Follow-up Period)
* likely to require treatment during the study with any of the restricted medications
* has any other clinically significant gynecologic condition identified during the main study on transvaginal ultrasound (TVUS), on endometrial biopsy or at the manual breast examination, which might interfere with the study efficacy and safety objectives
* meets any of the main study discontinuation criteria

Primary outcomes:
measure: Dysmenorrhea
timeFrame: 6 Months
measure: Non-menstrual Pelvic Pain
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Applied Res Center of Ar / Id # 735
state: Arkansas
city: Norwalk
country: United States
facility: Futura Research, Inc. / ID # 781
state: California
city: Greenwood Village
country: United States
facility: Adv Womens Health Institute / ID # 761
state: Colorado
city: Lakewood
country: United States
facility: Red Rocks OB/GYN / ID # 732
state: Colorado
city: Boca Raton
country: United States
facility: Dr. David I. Lubetkin, LLC / ID # 703
state: Florida
city: Miami
country: United States
facility: Coral Way Research / ID # 799
state: Florida
city: Miami
country: United States
facility: La Salud Research Clinic, Inc. / ID # 824
state: Florida
city: Orange City
country: United States
facility: A Premier Medical Research of Florida, LLC / ID # 752
state: Florida
city: Orlando
country: United States
facility: Clinical Associates of Orlando, LLC / ID # 779
state: Florida
city: Evergreen Park
country: United States
facility: Providea Health Partners LLC / ID # 734
state: Illinois
city: Flint
country: United States
facility: Onyx Clinical Research / ID # 793
state: Michigan
city: Saginaw
country: United States
facility: Valley OBGYN / ID # 704
state: Michigan
city: Columbus
country: United States
facility: ClinOhio Res Services, LLC / ID # 722
state: Ohio
city: Columbus
country: United States
facility: Complete Healthcare for Women / ID # 801
state: Ohio
city: Franklin
country: United States
facility: Hilltop OBGYN / ID # 711
state: Ohio
city: Nashville
country: United States
facility: Clinical Research Associates Inc / ID # 802
state: Tennessee
city: Austin
country: United States
facility: Austin Area ObGyn PLLC / ID # 701
state: Texas
city: Austin
country: United States
facility: OB/GYN North Austin / ID # 764
state: Texas
city: Dallas
country: United States
facility: HCWC dba DiscoveryClinical Trials / ID # 771
state: Texas
city: Fort Worth
country: United States
facility: Signature Gyn Services / ID # 726
state: Texas
city: Katy
country: United States
facility: Medical Colleagues of Texas / ID # 819
state: Texas
city: League City
country: United States
facility: Maximos OB/GYN
state: Texas
city: Draper
country: United States
facility: Physicians Research Options / ID # 766
state: Utah
city: Red Deer
country: Canada
facility: CARe Clinic / ID # 872
state: Alberta
city: Ponce
country: Puerto Rico
facility: Puerto Rico Medical Res Inc. / ID # 890
Study officials:
References: