EndometriosisPhase 3EDELWEISS 5NCT04372121
Extension to Study on 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 25 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 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
- 30 participants
- Where
- 25 sitesin 3 countries
- Study dates
- 23 Mar 2020to 16 Feb 2021
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
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 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
Trial locations and contacts
25 sites in 3 countries.
25 sites in 3 countries
United States23 sites
Austin Area ObGyn PLLC / ID # 701
Austin, Texas, 78758
OB/GYN North Austin / ID # 764
Austin, Texas, 78758
Dr. David I. Lubetkin, LLC / ID # 703
Boca Raton, Florida, 33486
ClinOhio Res Services, LLC / ID # 722
Columbus, Ohio, 43213
Complete Healthcare for Women / ID # 801
Columbus, Ohio, 43213
HCWC dba DiscoveryClinical Trials / ID # 771
Dallas, Texas, 75231
Physicians Research Options / ID # 766
Draper, Utah, 84020
Providea Health Partners LLC / ID # 734
Evergreen Park, Illinois, 60805
Onyx Clinical Research / ID # 793
Flint, Michigan, 48532
Signature Gyn Services / ID # 726
Fort Worth, Texas, 76104
Hilltop OBGYN / ID # 711
Franklin, Ohio, 45005
Adv Womens Health Institute / ID # 761
Greenwood Village, Colorado, 80111
Medical Colleagues of Texas / ID # 819
Katy, Texas, 77450
Red Rocks OB/GYN / ID # 732
Lakewood, Colorado, 80228
Maximos OB/GYN
League City, Texas, 77573
Applied Res Center of Ar / Id # 735
Little Rock, Arkansas, 72212
Coral Way Research / ID # 799
Miami, Florida, 33135
La Salud Research Clinic, Inc. / ID # 824
Miami, Florida, 33155
Clinical Research Associates Inc / ID # 802
Nashville, Tennessee, 37203
Futura Research, Inc. / ID # 781
Norwalk, California, 90650
A Premier Medical Research of Florida, LLC / ID # 752
Orange City, Florida, 32763
Clinical Associates of Orlando, LLC / ID # 779
Orlando, Florida, 32806
Valley OBGYN / ID # 704
Saginaw, Michigan, 48602
About this study
Official title: A Double-blind Randomized Extension Study to Assess the Long-term Efficacy and Safety of Linzagolix in Subjects With Endometriosis-associated Pain
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.
Read the 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.
- 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start23 Mar 2020
- Primary completion8 Jan 2021
- Study completion16 Feb 2021
Why it stopped: 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.
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.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372121
- Sponsor's protocol ID
- 19-OBE2109-005
- Acronym
- EDELWEISS 5
- Status last verified
- Dec 2021
- First submitted
- 29 Apr 2020
- Last updated
- 2 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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 Double-blind Randomized Extension Study to Assess the Long-term Efficacy and Safety of Linzagolix in Subjects With Endometriosis-associated Pain
- ClinicalTrials.gov ID
- NCT04372121
- Acronym / sponsor ID
- EDELWEISS 5 / 19-OBE2109-005
- Conditions
- Endometriosis
- Keywords
- Dysmenorrhea, Dyspareunia, Dyschezia, Non-menstrual pelvic pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Mar 2020 (actual)
- Primary completion
- 8 Jan 2021 (actual)
- Study completion
- 16 Feb 2021 (actual)
- First posted
- 1 May 2020 (actual)
- Results
- Posted 19 Mar 2025
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 tablet to match 200 mg linzagolix tabletFor oral administration once daily | Drug | Linzagolix 75 mg |
| Placebo capsule to match Add-back capsuleFor oral administration once daily | Drug | Linzagolix 75 mg |
Primary outcome
Dysmenorrhea
Time frame: 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
Time frame: 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.
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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 3 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 25 sites in 3 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 4 inclusion and 5 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: stopped early, 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 25 sites in United States, Canada, Puerto Rico. 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. 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 19 Mar 2025). 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?
Dysmenorrhea (time frame: 6 Months). 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?
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.