Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain
- Conditions
- Endometriosis
- Interventions
- Drug: Add-back capsule (E2 1 mg / NETA 0.5 mg)Drug: Placebo capsule to match Add-back capsule
- Registration Number
- NCT04372121
- Lead Sponsor
- Kissei Pharmaceutical Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 30
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Linzagolix 75 mg 75 mg linzagolix tablet - Linzagolix 75 mg Placebo tablet to match 200 mg linzagolix tablet - Linzagolix 200 mg + Add-back (E2 1 mg / NETA 0.5 mg) Add-back capsule (E2 1 mg / NETA 0.5 mg) - Linzagolix 75 mg Placebo capsule to match Add-back capsule - Linzagolix 200 mg + Add-back (E2 1 mg / NETA 0.5 mg) 200 mg linzagolix tablet - Linzagolix 200 mg + Add-back (E2 1 mg / NETA 0.5 mg) Placebo tablet to match 75 mg linzagolix tablet -
- Primary Outcome Measures
Name Time Method Dysmenorrhea 6 Months Monthly Severity Data of dysmenorrhea (DYS) at Month 6 were measured on a 4-point (0: No pain, 1: Mild pain, 2: Moderate pain, 3: Severe pain) Verbal Rating Scale (VRS). The "Mean±SD" of Monthly Severity Data for each treatment arm were calculated and provided as the efficacy data.
Non-menstrual Pelvic Pain 6 Months Monthly Severity Data of non-menstrual pelvic pain (NMPP) at Month 6 were measured on a 4-point (0: No pain, 1: Mild pain, 2: Moderate pain, 3: Severe pain) Verbal Rating Scale (VRS). The "Mean±SD" of Monthly Severity Data for each treatment arm were calculated and provided as the efficacy data.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (25)
Applied Res Center of Ar / Id # 735
🇺🇸Little Rock, Arkansas, United States
Dr. David I. Lubetkin, LLC / ID # 703
🇺🇸Boca Raton, Florida, United States
HCWC dba DiscoveryClinical Trials / ID # 771
🇺🇸Dallas, Texas, United States
Coral Way Research / ID # 799
🇺🇸Miami, Florida, United States
Onyx Clinical Research / ID # 793
🇺🇸Flint, Michigan, United States
Hilltop OBGYN / ID # 711
🇺🇸Franklin, Ohio, United States
La Salud Research Clinic, Inc. / ID # 824
🇺🇸Miami, Florida, United States
Clinical Research Associates Inc / ID # 802
🇺🇸Nashville, Tennessee, United States
Adv Womens Health Institute / ID # 761
🇺🇸Greenwood Village, Colorado, United States
Red Rocks OB/GYN / ID # 732
🇺🇸Lakewood, Colorado, United States
Futura Research, Inc. / ID # 781
🇺🇸Norwalk, California, United States
Clinical Associates of Orlando, LLC / ID # 779
🇺🇸Orlando, Florida, United States
A Premier Medical Research of Florida, LLC / ID # 752
🇺🇸Orange City, Florida, United States
Providea Health Partners LLC / ID # 734
🇺🇸Evergreen Park, Illinois, United States
Valley OBGYN / ID # 704
🇺🇸Saginaw, Michigan, United States
Complete Healthcare for Women / ID # 801
🇺🇸Columbus, Ohio, United States
Austin Area ObGyn PLLC / ID # 701
🇺🇸Austin, Texas, United States
OB/GYN North Austin / ID # 764
🇺🇸Austin, Texas, United States
ClinOhio Res Services, LLC / ID # 722
🇺🇸Columbus, Ohio, United States
Medical Colleagues of Texas / ID # 819
🇺🇸Katy, Texas, United States
Signature Gyn Services / ID # 726
🇺🇸Fort Worth, Texas, United States
Maximos OB/GYN
🇺🇸League City, Texas, United States
Physicians Research Options / ID # 766
🇺🇸Draper, Utah, United States
Puerto Rico Medical Res Inc. / ID # 890
🇵🇷Ponce, Puerto Rico
CARe Clinic / ID # 872
🇨🇦Red Deer, Alberta, Canada