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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-OBE2109-003 - Edelweiss 3 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 | Proportion of subjects with reduction of DYS (Month 3 MCT) and stable or decreased use of analgesics for EAP at Month 12 | 6-month extension study treatment period (from Month 6 to Month 12) |
| Non-menstrual Pelvic Pain | Proportion of subjects with reduction of NMPP (Month 3 MCT) and stable or decreased use of analgesics for EAP at Month 12 | 6-month extension study treatment period (from Month 6 to Month 12) |
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Inclusion Criteria:
The subject must have:
Exclusion Criteria:
The subject will be excluded if she:
Females Only
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| Name | Affiliation | Role |
|---|---|---|
| Lecomte | ObsEva SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Choice Research, LLC/ ID # 609 | Dothan | Alabama | 36303 | United States | ||
| Universal Axon - Homestead, LLC/ ID # 620 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42077502 | Derived | Donnez J, Becker CM, Petraglia F, Horne AW, Becker S, Renner SP, Carmona Herrera F, Taylor HS, Paszkowski M, Bestel E, Hori S, Dolmans MM. Linzagolix, with and without add-back therapy, in women with endometriosis-associated pain: results from EDELWEISS 6, a double-blind randomized extension and withdrawal study. Hum Reprod Open. 2026 Apr 8;2026(2):hoag030. doi: 10.1093/hropen/hoag030. eCollection 2026. |
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Subjects who received placebo in the main study were randomized in a 1:1 ratio to either linzagolix (=LGX) 75 mg alone (with Add-back (=ABT) placebo) or LGX 200 mg with ABT, as per the main study randomization schedule. Subjects who received active treatment continued with the same treatment (LGX 75 mg alone or LGX 200 mg with ABT).
Overall, 356 subjects entered the extension study and were treated. With the exception of 3 subjects who met a discontinuation criterion at Month 6, all other subjects who entered the extension study were included in the TEAS. The PP EAS consisted of 336 subjects. All 356 subjects who entered the extension study were included in the ESAF.
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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]
|
| FG001 |
| 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 25, 2020 | Mar 25, 2025 |
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| 200 mg linzagolix tablet |
| 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 |
|
| Add-back capsule (E2 1 mg / NETA 0.5 mg) | Drug | For oral administration once daily |
|
| Placebo capsule to match Add-back capsule | Drug | For oral administration once daily |
|
| Homestead |
| Florida |
| 33030 |
| United States |
| Stedman Clinical Trials/ ID # 612 | Tampa | Florida | 33613 | United States |
| Advanced Specialty Research/ ID # 610 | Nampa | Idaho | 83687 | United States |
| Women's & Family Care, LLC dba GTC Research/ ID # 608 | Shawnee Mission | Kansas | 66218 | United States |
| Southern Clinical Research / ID # 611 | Metairie | Louisiana | 70001 | United States |
| Chattanooga Medical Research LLC/ ID# 602 | Chattanooga | Tennessee | 37404 | United States |
| Tanner Clinic/ ID # 624 | Layton | Utah | 84041 | United States |
| Salzburger Landeskliniken / ID # 105 | Salzburg | 5020 | Austria |
| Multiprofile Hospital for Active Treatment Sliven/ ID # 131 | Sliven | 8800 | Bulgaria |
| MHAT Dr. Bratan Shukerov / ID #138 | Smolyan | Bulgaria |
| Medical Centre Excelsior /ID # 135 | Sofia | 1407 | Bulgaria |
| Group Practice for Specialized Medical Assistance in GINART/ ID # 132 | Sofia | 1606 | Bulgaria |
| University Multiprofile Hospital for Active Treatment "Sofiamed"/ ID # 133 | Sofia | 1797 | Bulgaria |
| Gynekologicko - Porodnicka Ambulance/ ID # 162 | Tábor | 39003 | Czechia |
| Gynekologie MU Dr.Lubomir Mikulasek / ID # 160 | Újezd nad Lesy | 19016 | Czechia |
| Clinique Pasteur / ID # 206 | Toulouse | 31076 | France |
| Lubelskie Centrum Diagnostyczne/ ID # 402 | Świdnik | Lublin Voivodeship | 21-040 | Poland |
| Prywatna Klinika Ginekologiczno - Położnicza/ ID # 404 | Bialystok | Podlaskie Voivodeship | 15-224 | Poland |
| Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof Wilk/ ID # 411 | Katowice | 40-301 | Poland |
| Clinical Medical Research sp. Z o. O/ ID # 406 | Katowice | 40-628 | Poland |
| Niepubliczny Zaklad Opieki Zrowotnej GynCentrum/ ID # 407 | Katowice | 40-851 | Poland |
| Kotarski Jan Specjalistyczny Gabinet Ginekologiczno Polozniczy/ ID # 405 | Lublin | 20-064 | Poland |
| Centrum Medyczne Chodźki Lublin/ ID # 403 | Lublin | 20-093 | Poland |
| VITA LONGA Sp. z o.o./ ID # 408 | Lublin | 20-093 | Poland |
| Centrum Ginekologii Endokrynologii i Medycyny Rozrodu "Artemida"/ ID # 409 | Olsztyn | 10-357 | Poland |
| Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu/ ID # 410 | Przemyśl | 37-700 | Poland |
| Specjalistyczny Gabinet Lekarski Krzysztof Dynowski / ID # 401 | Warsaw | 02-929 | Poland |
| Quantum Medical Center SRL/ ID # 353 | Bucharest | 12071 | Romania |
| Centrul Medical EUROMED/ ID # 351 | Bucharest | 20764 | Romania |
| Spitalul Clinic "Nicolae Malaxa"/ ID # 352 | Bucharest | 22448 | Romania |
| Sp Cl de Obstetrica si Ginecologie "Prof. Dr. Panait Sirbu"/ ID # 354 | Bucharest | 60251 | Romania |
| Gine Plus SRL Cluj- Napoca/ ID # 357 | Cluj-Napoca | 400698 | Romania |
| Centrul Medical GALENUS/ ID # 355 | Târgu Mureş | 540236 | Romania |
| Hospital Regional Universitario de Málaga/ ID # 303 | Málaga | 29010 | Spain |
| Hospital General Universitario Reina Sofia/ ID # 304 | Murcia | 30003 | Spain |
| City clinical maternity hospital №1/ ID # 502 | Chernivtsi | 58003 | Ukraine |
| Ivano-Frankivsk regional perinatal center, Family planning center/ ID # 506 | Ivano-Frankivsk | 76018 | Ukraine |
| Kyiv City Maternity Hospital #6/ ID # 504 | Kyiv | 02125 | Ukraine |
| Medical center of LLC "Medical Center "Verum"/ ID # 503 | Kyiv | 03039 | Ukraine |
| Institute of Pediatrics Obstetrics and Gynecology/ ID # 508 | Kyiv | 04050 | Ukraine |
| Kyiv City Clinical Hospital #9/ ID # 501 | Kyiv | 04112 | Ukraine |
| Kyiv City Center of Reproductive and Perinatal Medicine/ ID # 509 | Kyiv | 04210 | Ukraine |
| Ternopil' Communal City Hospital#2 / ID # 511 | Ternopil | 46400 | Ukraine |
| Vinnytsia City Clinical Hospital "Center of Mother and the Child "/ ID # 510 | Vinnytsia | 21019 | Ukraine |
| Zaporizhzhya Regional Clinical Hospital/ ID # 505 | Zaporizhzhya | 69000 | Ukraine |
| Maternity Hospital № 3/ ID # 507 | Zaporizhzhya | 69071 | Ukraine |
| LGX 200 mg+ABT |
[Main study: 6 months] The IMPs mentioned below were administered once daily orally.
[Extension study: 6 months]
|
| FG002 | Placebo / LGX 75 mg | [Main study: 6 months] The IMPs mentioned below were administered once daily orally.
[Extension study: 6months]
|
| FG003 | Placebo / LGX 200 mg+ABT | [Main study: 6 months] The IMPs mentioned below were administered once daily orally.
[Extension study: 6 months]
|
| 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 | Proportion of subjects with reduction of DYS (Month 3 MCT) and stable or decreased use of analgesics for EAP at Month 12 | Posted | Count of Participants | Participants | 6-month extension study treatment period (from Month 6 to Month 12) |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Non-menstrual Pelvic Pain | Proportion of subjects with reduction of NMPP (Month 3 MCT) and stable or decreased use of analgesics for EAP at Month 12 | Posted | Count of Participants | Participants | 6-month extension study treatment period (from Month 6 to Month 12) |
|
6-month extension study treatment period (from Month 6 to Month 12)
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 unfavorable 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 | 119 | 3 | 119 | 26 | 119 |
| 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 | 122 | 0 | 122 | 19 | 122 |
| 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 | 58 | 0 | 58 | 15 | 58 |
| 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 | 57 | 1 | 57 | 13 | 57 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Genital haemorrhage | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Vaginal haemorrhage | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Cholelithiasis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hot flush | Vascular disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Vaginal haemorrhage | Reproductive system and breast disorders | Systematic Assessment |
| ||
| COVID-19 | Infections and infestations | Systematic Assessment |
| ||
| Vulvovaginal mycotic infection | Infections and infestations | Systematic Assessment |
|
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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 | Aug 28, 2023 | Mar 25, 2025 | SAP_003.pdf |
| 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 |
|
| Romania |
|
| Czechia |
|
| Ukraine |
|
| Poland |
|
| Bulgaria |
|
| Spain |
|
| United States |
|
| 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 |
|
|