EndometriosisPhase 3NCT03992846
Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain.
A Phase 3 study testing 75 mg linzagolix tablet, 200 mg linzagolix tablet and Add-back capsule (E2 1 mg / NETA 0.5 mg) in people with Endometriosis, run by Kissei Pharmaceutical Co., Ltd. at 71 sites in 10 countries.
Trial summary
The primary objective of this study is to demonstrate the efficacy and safety of linzagolix administered orally once daily for 3 months at a dose of 75 mg alone or of 200 mg in combination with add-back hormone replacement therapy (ABT: estradiol (E2) 1 mg / norethisterone acetate (NETA) 0.5 mg) versus placebo, in the… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- 75 mg linzagolix tablet, 200 mg linzagolix tablet and Add-back capsule (E2 1 mg / NETA 0.5 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 486 participants
- Where
- 71 sitesin 10 countries
- Study dates
- 13 Jun 2019to 1 Apr 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- The subject must have:
- Her most recent surgical and - if available - histological diagnosis of pelvic endometriosis up to 10 years before screening.
- Moderate to severe endometriosis-associated pain during the screening period.
- Regular menstrual cycles.
- BMI ≥ 18 kg/m2 at the screening visit. -
Who cannot join
- The subject will be excluded if she:
- Is pregnant or breast feeding or is planning a pregnancy within the duration of the treatment period of the study.
- Is less than 6 months postpartum or 3 months postabortion/ miscarriage at the time of entry into the screening period.
- Has had a surgical history of any major abdominal surgery within 6 months or any interventional surgery for endometriosis performed within a period of 2 months before screening.
- Did not respond to prior treatment with GnRH agonists or GnRH antagonists for endometriosis.
- Has a history of, or known, osteoporosis or other metabolic bone disease.
- Has chronic pelvic pain that is not caused by endometriosis and requires chronic analgesic or other chronic therapy which would interfere with the assessment of endometriosis-associated pain.
Trial locations and contacts
71 sites in 10 countries.
71 sites in 10 countries
United States22 sites
Achieve Clinical Research/ ID # 601
Birmingham, Alabama, 35218
Chattanooga Medical Research LLC/ ID# 602
Chattanooga, Tennessee, 37404
Southeast Clinical Research/ ID # 618
Chiefland, Florida, 32626
Choice Research, LLC/ ID # 609
Dothan, Alabama, 36303
Obstetrics & Gynecology Associates, Inc./ ID# 606
Fairfield, Ohio, 45014
Universal Axon - Homestead, LLC/ ID # 620
Homestead, Florida, 33030
Next Innovative Clinical Research/ ID # 617
Houston, Texas, 77021
Multi-Specialty Research Associates, Inc./ ID # 625
Lake City, Florida, 32055
The Center for Women's Health & Wellnes/ ID # 603
Lawrenceville, New Jersey, 08648
Tanner Clinic/ ID # 624
Layton, Utah, 84041
Wellington Anti-Aging, LLC/ ID # 613
Loxahatchee Groves, Florida, 33470
Southern Clinical Research / ID # 611
Metairie, Louisiana, 70001
Adventura Clinical Research/ ID # 616
Miramar, Florida, 33012
Advanced Specialty Research/ ID # 610
Nampa, Idaho, 83687
Affinity Clinical Research Institute/ ID # 622
Oak Brook, Illinois, 60523
Women's & Family Care, LLC dba GTC Research/ ID # 608
Shawnee Mission, Kansas, 66218
Quad Clinical Research LLC/ ID # 615
St Louis, Missouri, 63109
Storks Research, LLC/ ID # 623
Sugar Land, Texas, 77479
Stedman Clinical Trials/ ID # 612
Tampa, Florida, 33613
Invocare Medical Research & Healthcare Center/ ID # 607
West Columbia, South Carolina, 29169
PMG Research of Wilmington/ ID # 614
Wilmington, North Carolina, 28412
UWCR - Lyndhurst Clinical Researc/ ID# 605
Winston-Salem, North Carolina, 27103
Poland11 sites
Prywatna Klinika Ginekologiczno - Położnicza/ ID # 404
Bialystok, Podlaskie Voivodeship, 15-224
VITA LONGA Sp. z o.o./ ID # 408
Katowice, 20-093
Clinical Medical Research sp. Z o. O/ ID # 406
Katowice, 40-001
Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof Wilk/ ID # 411
Katowice, 40-301
Niepubliczny Zaklad Opieki Zrowotnej GynCentrum/ ID # 407
Katowice, 40-851
Kotarski Jan Specjalistyczny Gabinet Ginekologiczno Polozniczy/ ID # 405
Lublin, 20-064
Centrum Medyczne Chodźki Lublin/ ID # 403
Lublin, 20-093
Centrum Ginekologii Endokrynologii i Medycyny Rozrodu "Artemida"/ ID # 409
Olsztyn, 10-357
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu/ ID # 410
Przemyśl, 37-700
Lubelskie Centrum Diagnostyczne/ ID # 402
Świdnik, Lublin Voivodeship, 21-040
Specjalistyczny Gabinet Lekarski Krzysztof Dynowski / ID # 401
Warsaw, 02-929
Ukraine11 sites
City clinical maternity hospital №1/ ID # 502
Chernivtsi, 58003
Ivano-Frankivsk regional perinatal center, Family planning center/ ID # 506
Ivano-Frankivsk, 76018
Kyiv City Maternity Hospital #6/ ID # 504
Kyiv, 02125
Medical center of LLC "Medical Center "Verum"/ ID # 503
Kyiv, 03039
Institute of Pediatrics Obstetrics and Gynecology/ ID # 508
Kyiv, 04050
Kyiv City Clinical Hospital #9/ ID # 501
Kyiv, 04112
Kyiv City Center of Reproductive and Perinatal Medicine/ ID # 509
Kyiv, 04210
Ternopil' Communal City Hospital #2/ ID # 511
Ternopil, 46400
Vinnytsia City Clinical Hospital "Center of Mother and the Child "/ ID # 510
Vinnytsia, 21019
Zaporizhzhya Regional Clinical Hospital/ ID # 505
Zaporizhzhya, 69000
Maternity Hospital № 3/ ID # 507
Zaporizhzhya, 69071
Bulgaria6 sites
Multiprofile Hospital for Active Treatment Sliven/ ID # 131
Sliven, 8800
MHAT Dr. Bratan Shukerov / ID #138
Smolyan
Medical Centre Excelsior /ID # 135
Sofia, 1407
Group Practice for Specialized Medical Assistance in GINART/ ID # 132
Sofia, 1606
Multiprofile Hospital for Active Treatment St. Sofia/ ID # 137
Sofia, 1618
University Multiprofile Hospital for Active Treatment "Sofiamed"/ ID # 133
Sofia, 1797
Romania6 sites
Quantum Medical Center SRL/ ID # 353
Bucharest, 12071
Centrul Medical EUROMED/ ID # 351
Bucharest, 20764
Spitalul Clinic "Nicolae Malaxa"/ ID # 352
Bucharest, 22448
Sp Cl de Obstetrica si Ginecologie "Prof. Dr. Panait Sirbu"/ ID # 354
Bucharest, 60251
Gine Plus SRL Cluj- Napoca/ ID # 357
Cluj-Napoca, 400698
Centrul Medical GALENUS/ ID # 355
Târgu Mureş, 540236
Hungary4 sites
Principal SMO Kft/ ID # 250
Baja, Bács-Kiskun county, 6500
Róbert Károly Magánkórház/ ID # 253
Budapest, 1135
Szent Anna Szuleszeti-Nogyogyaszati/ ID # 251
Debrecen, 4024
Mediroyal Prevencios Kozpont/ ID # 252
Kecskemét, 6000
Austria3 sites
Salzburger Landeskliniken / ID # 105
Salzburg, 5020
AKH Vienna University of Medicine Vienna / ID # 101
Vienna, 1090
AKH Vienna University of Medicine Vienna/ ID # 103
Vienna, 1090
Czechia3 sites
MUDr Jan Drahonovsky, Ustav pro peci o matku a dite/ ID #163
Prague, 14700
Gynekologicko - Porodnicka Ambulance/ ID # 162
Tábor, 39003
Gynekologie MU Dr.Lubomir Mikulasek / ID # 160
Újezd nad Lesy, 19016
France3 sites
CHRU Besançon Hopital/ ID # 204
Besançon, 25000
CHRU Strasbourg - Hopital Hautepierre/ ID # 205
Strasbourg, 67200
Clinique Pasteur / ID # 206
Toulouse, 31076
Spain2 sites
Hospital Regional Universitario de Málaga/ ID # 303
Málaga, 29010
Hospital General Universitario Reina Sofia/ ID # 304
Murcia, 30003
About this study
Official title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled, Clinical Study to Assess the Efficacy and Safety of Linzagolix in Subjects With Moderate to Severe Endometriosis-associated Pain.
The primary objective of this study is to demonstrate the efficacy and safety of linzagolix administered orally once daily for 3 months at a dose of 75 mg alone or of 200 mg in combination with add-back hormone replacement therapy (ABT: estradiol (E2) 1 mg / norethisterone acetate (NETA) 0.5 mg) versus placebo, in the management of moderate to severe endometriosis-associated pain (EAP).
Read the detailed description
This is a prospective, randomized, double-blind, placebo-controlled study to demonstrate the efficacy and safety of linzagolix administered orally once daily at doses of 75 mg alone and 200 mg in combination with low dose ABT (E2 1 mg/NETA 0.5 mg) versus placebo in the management of moderate to severe EAP in 450 women.
Eligible subjects who have completed the 6-month treatment period may enter a separate extension study for 6 additional months of active treatment (no placebo control). Subjects who do not continue in the extension study will enter a 6 month treatment-free follow-up phase.
- Conditions
- Endometriosis
- Being tested
- 75 mg linzagolix tablet, 200 mg linzagolix tablet, Add-back capsule (E2 1 mg / NETA 0.5 mg), Placebo tablet to match 75 mg linzagolix tablet, Placebo tablet to match 200 mg linzagolix tablet
- Keywords
- Dysmenorrhea, Dyspareunia, Dyschezia, Non-menstrual pelvic pain
- Medical subject headings
- Endometriosis, Dysmenorrhea, Dyspareunia, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
75 mg linzagolix tabletDrug
For oral administration once daily
200 mg linzagolix tabletDrug
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 tabletDrug
For oral administration once daily
Placebo tablet to match 200 mg linzagolix tabletDrug
For oral administration once daily
Placebo capsule to match Add-back capsuleDrug
For oral administration once daily
| Study group | Role | What they receive |
|---|---|---|
| Linzagolix 75 mg | Experimental | Not described Receives: Drug: 75 mg linzagolix tablet; Drug: Placebo tablet to match 200 mg linzagolix tablet; Drug: Placebo capsule to match Add-back capsule |
| Linzagolix 200 mg + Add-back (E2 1 mg / NETA 0.5 mg) | Experimental | Not described Receives: Drug: 200 mg linzagolix tablet; Drug: Add-back capsule (E2 1 mg / NETA 0.5 mg); Drug: Placebo tablet to match 75 mg linzagolix tablet |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo tablet to match 75 mg linzagolix tablet; Drug: Placebo tablet to match 200 mg linzagolix tablet; Drug: Placebo capsule to match Add-back capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Dysmenorrhea (DYS) at Month 3 - Proportion of Responders
Percentage of subjects with reduction of 1.1 for DYS in mean pelvic pain score within last 28 days prior to Month 3 or discontinuation, and stable or decreased use of analgesics for Endometriosis-associated pain (=EAP) within the same calendar days.
Measured: Baseline to Month 3
Reduction of Non-menstrual Pelvic Pain (NMPP) at Month 3 - Proportion of Responders
Percentage of subjects with reduction of 0.8 for NMPP in mean pelvic pain score within last 28 days prior to Month 3 or discontinuation, and stable or decreased use of analgesics for Endometriosis-associated pain (=EAP) within the same calendar days.
Measured: Baseline to Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start13 Jun 2019
- Primary completion18 Oct 2021
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 486 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lecomte, Study director, ObsEva SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03992846
- Sponsor's protocol ID
- 18-OBE2109-003
- Status last verified
- Jun 2022
- First submitted
- 18 Jun 2019
- Last updated
- 2 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Donnez J, Becker C, Taylor H, Carmona Herrera F, Donnez O, Horne A, Paszkowski M, Petraglia F, Renner SP, Patel A, Boolell M, Bestel E, Dolmans MM. Linzagolix therapy versus a placebo in patients with endometriosis-associated pain: a prospective, randomized, double-blind, Phase 3 study (EDELWEISS 3). Hum Reprod. 2024 Jun 3;39(6):1208-1221. doi: 10.1093/humrep/deae076.
PubMed 38648863
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled, Clinical Study to Assess the Efficacy and Safety of Linzagolix in Subjects With Moderate to Severe Endometriosis-associated Pain.
- ClinicalTrials.gov ID
- NCT03992846
- Acronym / sponsor ID
- 18-OBE2109-003
- Conditions
- Endometriosis
- Keywords
- Dysmenorrhea, Dyspareunia, Dyschezia, Non-menstrual pelvic pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 486 participants (actual)
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Jun 2019 (actual)
- Primary completion
- 18 Oct 2021 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 20 Jun 2019 (actual)
- Results
- Posted 29 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to demonstrate the efficacy and safety of linzagolix administered orally once daily for 3 months at a dose of 75 mg alone or of 200 mg in combination with add-back hormone replacement therapy (ABT: estradiol (E2) 1 mg / norethisterone acetate (NETA) 0.5 mg) versus placebo, in the management of moderate to severe endometriosis-associated pain (EAP).
Detailed description
This is a prospective, randomized, double-blind, placebo-controlled study to demonstrate the efficacy and safety of linzagolix administered orally once daily at doses of 75 mg alone and 200 mg in combination with low dose ABT (E2 1 mg/NETA 0.5 mg) versus placebo in the management of moderate to severe EAP in 450 women.
Eligible subjects who have completed the 6-month treatment period may enter a separate extension study for 6 additional months of active treatment (no placebo control). Subjects who do not continue in the extension study will enter a 6 month treatment-free follow-up phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Linzagolix 75 mg | Experimental | Drug: 75 mg linzagolix tablet, Drug: Placebo tablet to match 200 mg linzagolix tablet, Drug: Placebo capsule to match Add-back capsule |
| Linzagolix 200 mg + Add-back (E2 1 mg / NETA 0.5 mg) | Experimental | Drug: 200 mg linzagolix tablet, Drug: Add-back capsule (E2 1 mg / NETA 0.5 mg), Drug: Placebo tablet to match 75 mg linzagolix tablet |
| Placebo | Placebo comparator | Drug: Placebo tablet to match 75 mg linzagolix tablet, Drug: Placebo tablet to match 200 mg linzagolix tablet, Drug: Placebo capsule to match Add-back capsule |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Her most recent surgical and - if available - histological diagnosis of pelvic endometriosis up to 10 years before screening.
- Moderate to severe endometriosis-associated pain during the screening period.
- Regular menstrual cycles.
- BMI ≥ 18 kg/m2 at the screening visit. -
Key exclusion criteria (7 listed)
- Is pregnant or breast feeding or is planning a pregnancy within the duration of the treatment period of the study.
- Is less than 6 months postpartum or 3 months postabortion/ miscarriage at the time of entry into the screening period.
- Has had a surgical history of any major abdominal surgery within 6 months or any interventional surgery for endometriosis performed within a period of 2 months before screening.
- Did not respond to prior treatment with GnRH agonists or GnRH antagonists for endometriosis.
- Has a history of, or known, osteoporosis or other metabolic bone disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 75 mg linzagolix tabletFor oral administration once daily | Drug | Linzagolix 75 mg |
| 200 mg linzagolix tabletFor oral administration once daily | Drug | Linzagolix 200 mg + Add-back (E2 1 mg / NETA 0.5 mg) |
| Add-back capsule (E2 1 mg / NETA 0.5 mg)For oral administration once daily | Drug | Linzagolix 200 mg + Add-back (E2 1 mg / NETA 0.5 mg) |
| Placebo tablet to match 75 mg linzagolix tabletFor oral administration once daily | Drug | Linzagolix 200 mg + Add-back (E2 1 mg / NETA 0.5 mg), Placebo |
| Placebo tablet to match 200 mg linzagolix tabletFor oral administration once daily | Drug | Linzagolix 75 mg, Placebo |
| Placebo capsule to match Add-back capsuleFor oral administration once daily | Drug | Linzagolix 75 mg, Placebo |
Primary outcome
Reduction of Dysmenorrhea (DYS) at Month 3 - Proportion of Responders
Time frame: Baseline to Month 3
Percentage of subjects with reduction of 1.1 for DYS in mean pelvic pain score within last 28 days prior to Month 3 or discontinuation, and stable or decreased use of analgesics for Endometriosis-associated pain (=EAP) within the same calendar days.
Reduction of Non-menstrual Pelvic Pain (NMPP) at Month 3 - Proportion of Responders
Time frame: Baseline to Month 3
Percentage of subjects with reduction of 0.8 for NMPP in mean pelvic pain score within last 28 days prior to Month 3 or discontinuation, and stable or decreased use of analgesics for Endometriosis-associated pain (=EAP) within the same calendar days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38648863Donnez J, Becker C, Taylor H, Carmona Herrera F, Donnez O, Horne A, Paszkowski M, Petraglia F, Renner SP, Patel A, Boolell M, Bestel E, Dolmans MM. Linzagolix therapy versus a placebo in patients with endometriosis-associated pain: a prospective, randomized, double-blind, Phase 3 study (EDELWEISS 3). Hum Reprod. 2024 Jun 3;39(6):1208-1221. doi: 10.1093/humrep/deae076.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lecomte study director
ObsEva SA
71 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 75 mg linzagolix tablet, 200 mg linzagolix tablet and Add-back capsule (E2 1 mg / NETA 0.5 mg) in people with Endometriosis, run by Kissei Pharmaceutical Co., Ltd. at 71 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 71 sites in United States, Poland, Ukraine, Bulgaria, Romania and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of Dysmenorrhea (DYS) at Month 3 - Proportion of Responders (time frame: Baseline to Month 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03992846, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.