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This study is an extension of Study 18-OBE2109-002 that has been terminated due to enrolment challenges. Consequently, this study has also been terminated.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Linzagolix 75 mg | Experimental |
| |
| Linzagolix 200 mg + Add-back (E2 1 mg / NETA 0.5 mg) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 75 mg linzagolix tablet | Drug | For oral administration once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Dysmenorrhea | 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. | 6 Months |
| Non-menstrual Pelvic Pain | 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. | 6 Months |
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Inclusion Criteria:
The subject must have:
Exclusion Criteria:
The subject will be excluded if she:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Applied Res Center of Ar / Id # 735 | Little Rock | Arkansas | 72212 | United States | ||
| Futura Research, Inc. / ID # 781 |
Subjects who received placebo in the main study were randomized in a 1:1 ratio to either linzagolix 75 mg alone (with ABT-matching placebo) or linzagolix 200 mg with ABT, as per the main study randomization schedule.
Of the 85 subjects randomized in the Edelweiss 2 study, 37 completed the 6-month treatment. Of the 37 subjects, 30 subjects opted to participate in the current extension study (7 from Placebo, 13 from LGX 75 mg, and 10 from LGX 200 mg+ABT). At entry into the extension study, the 7 subjects in the placebo group were re-randomized to an active LGX group (PBO/LGX 75 mg: 3, PBO/LGX 200 mg+ABT: 4). Subjects receiving LGX during Edelweiss 2 study, continued treatment as randomized in the main study.
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| ID | Title | Description |
|---|---|---|
| FG000 | LGX 75 mg | [Main study: 6 months] The IMPs mentioned below were administered once daily orally.
[Extension study: 6 months] Same treatment as the main study |
| FG001 | LGX 200 mg+ABT |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 24, 2020 | Mar 25, 2025 |
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| 200 mg linzagolix tablet |
| Drug |
For oral administration once daily |
|
| Add-back capsule (E2 1 mg / NETA 0.5 mg) | Drug | For oral administration once daily |
|
| Placebo tablet to match 75 mg linzagolix tablet | Drug | For oral administration once daily |
|
| Placebo tablet to match 200 mg linzagolix tablet | Drug | For oral administration once daily |
|
| Placebo capsule to match Add-back capsule | Drug | For oral administration once daily |
|
| Norwalk |
| California |
| 90650 |
| United States |
| Adv Womens Health Institute / ID # 761 | Greenwood Village | Colorado | 80111 | United States |
| Red Rocks OB/GYN / ID # 732 | Lakewood | Colorado | 80228 | United States |
| Dr. David I. Lubetkin, LLC / ID # 703 | Boca Raton | Florida | 33486 | United States |
| Coral Way Research / ID # 799 | Miami | Florida | 33135 | United States |
| La Salud Research Clinic, Inc. / ID # 824 | Miami | Florida | 33155 | United States |
| A Premier Medical Research of Florida, LLC / ID # 752 | Orange City | Florida | 32763 | United States |
| Clinical Associates of Orlando, LLC / ID # 779 | Orlando | Florida | 32806 | United States |
| Providea Health Partners LLC / ID # 734 | Evergreen Park | Illinois | 60805 | United States |
| Onyx Clinical Research / ID # 793 | Flint | Michigan | 48532 | United States |
| Valley OBGYN / ID # 704 | Saginaw | Michigan | 48602 | United States |
| ClinOhio Res Services, LLC / ID # 722 | Columbus | Ohio | 43213 | United States |
| Complete Healthcare for Women / ID # 801 | Columbus | Ohio | 43213 | United States |
| Hilltop OBGYN / ID # 711 | Franklin | Ohio | 45005 | United States |
| Clinical Research Associates Inc / ID # 802 | Nashville | Tennessee | 37203 | United States |
| Austin Area ObGyn PLLC / ID # 701 | Austin | Texas | 78758 | United States |
| OB/GYN North Austin / ID # 764 | Austin | Texas | 78758 | United States |
| HCWC dba DiscoveryClinical Trials / ID # 771 | Dallas | Texas | 75231 | United States |
| Signature Gyn Services / ID # 726 | Fort Worth | Texas | 76104 | United States |
| Medical Colleagues of Texas / ID # 819 | Katy | Texas | 77450 | United States |
| Maximos OB/GYN | League City | Texas | 77573 | United States |
| Physicians Research Options / ID # 766 | Draper | Utah | 84020 | United States |
| CARe Clinic / ID # 872 | Red Deer | Alberta | T4N 6V7 | Canada |
| Puerto Rico Medical Res Inc. / ID # 890 | Ponce | 00717 | Puerto Rico |
[Main study: 6 months] The IMPs mentioned below were administered once daily orally.
[Extension study: 6 months] Same treatment as the main study |
| FG002 | Placebo/LGX 75 mg | [Main study: 6 months] The IMPs mentioned below were administered once daily orally.
[Extension study: 6months] Same treatment as LGX 75 mg group in the extension study |
| FG003 | Placebo/LGX 200 mg+ABT | [Main study: 6 months] The IMPs mentioned below were administered once daily orally.
[Extension study: 6 months] Same treatment as LGX 200 mg+ABT group in the extension study |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LGX 75 mg | [Main study: 6 months] The IMPs mentioned below were administered once daily orally.
[Extension study: 6 months] Same treatment as the main study |
| BG001 | LGX 200 mg+ABT | [Main study: 6 months] The IMPs mentioned below were administered once daily orally.
[Extension study: 6 months] Same treatment as the main study |
| BG002 | Placebo/LGX 75 mg | [Main study: 6 months] The IMPs mentioned below were administered once daily orally.
[Extension study: 6months] Same treatment as LGX 75 mg group in the extension study |
| BG003 | Placebo/LGX 200 mg+ABT | [Main study: 6 months] The IMPs mentioned below were administered once daily orally.
[Extension study: 6 months] Same treatment as LGX 200 mg+ABT group in the extension study |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Age, Customized | Median | Inter-Quartile Range | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| BMI | Mean | Standard Deviation | kg/m2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Dysmenorrhea | 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. | Of the 37 subjects who completed the main study (NCT03986944), 30 subjects participated in the extension study (NCT04372121). Of these 30, there were no subjects who had the Monthly Severity Data of DYS and/or NMPP on Day 1 or Month 12 to evaluate the efficacy but there were 5 subjects that had Monthly Severity Data on Month 6. | Posted | Mean | Standard Deviation | score on a scale | 6 Months |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | Non-menstrual Pelvic Pain | 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. | Of the 37 subjects who completed the main study (NCT03986944), 30 subjects participated in the extension study (NCT04372121). Of these 30, there were no subjects who had the Monthly Severity Data of DYS and/or NMPP on Day 1 or Month 12 to evaluate the efficacy but there were 5 subjects that had Monthly Severity Data on Month 6. | Posted | Mean | Standard Deviation | score on a scale | 6 Months |
|
Month 6 to Month 12 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavourable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LGX 75 mg | [Main study: 6 months] The IMPs mentioned below were administered once daily orally.
[Extension study: 6 months] Same treatment as the main study | 0 | 13 | 1 | 13 | 4 | 13 |
| EG001 | LGX 200 mg+ABT | [Main study: 6 months] The IMPs mentioned below were administered once daily orally.
[Extension study: 6 months] Same treatment as the main study | 0 | 10 | 0 | 10 | 4 | 10 |
| EG002 | Placebo/LGX 75 mg | [Main study: 6 months] The IMPs mentioned below were administered once daily orally.
[Extension study: 6months] Same treatment as LGX 75 mg group in the extension study | 0 | 3 | 0 | 3 | 0 | 3 |
| EG003 | Placebo/LGX 200 mg+ABT | [Main study: 6 months] The IMPs mentioned below were administered once daily orally.
[Extension study: 6 months] Same treatment as LGX 200 mg+ABT group in the extension study | 0 | 4 | 0 | 4 | 0 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gallbladder polyp | Hepatobiliary disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Menstruation irregular | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Pelvic pain | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Vaginal discharge | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Tendon injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Platelet count decreased | Investigations | Systematic Assessment |
|
The main study (NCT03986944) was prematurely terminated by the impact of the COVID-19 pandemic. As a result, the extension study (NCT04372121) was also terminated early before enough subjects could be enrolled and treated for the evaluation of the planned efficacy endpoints. So, we quantified the Monthly Severity Data at Month 6 for the 5 subjects (i.e. 0: No pain, 1: Mild pain, 2: Moderate pain, 3: Severe pain) and showed the "Mean±SD" for each treatment arm as the efficacy data.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Division | Kissei Pharmaceutical Co., Ltd | Email only | rinsyousiken@pharm.kissei.co.jp |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 18, 2021 | Mar 25, 2025 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D004412 | Dysmenorrhea |
| D004414 | Dyspareunia |
| D003248 | Constipation |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D005832 | Genital Diseases, Male |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D012817 | Signs and Symptoms, Digestive |
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| ID | Term |
|---|---|
| C000716911 | linzagolix |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Puerto Rico |
|
| United States |
|
[Main study: 6 months] The IMPs mentioned below were administered once daily orally.
[Extension study: 6months] Same treatment as LGX 75 mg group in the extension study |
| OG003 | Placebo/LGX 200 mg+ABT | [Main study: 6 months] The IMPs mentioned below were administered once daily orally.
[Extension study: 6 months] Same treatment as LGX 200 mg+ABT group in the extension study |
|
|