Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain (EDELWEISS 6)
Public ClinicalTrials.gov record NCT04335591. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Double-blind Randomized Extension Study to Assess the Long-term Efficacy and Safety of Linzagolix in Subjects With Endometriosis-associated Pain
Study identification
- NCT ID
- NCT04335591
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.
- Industry
- Enrollment
- 356 participants
Conditions and interventions
Conditions
Interventions
- 75 mg linzagolix tablet Drug
- 200 mg linzagolix tablet Drug
- Placebo tablet to match 75 mg linzagolix tablet Drug
- Placebo tablet to match 200 mg linzagolix tablet Drug
- Add-back capsule (E2 1 mg / NETA 0.5 mg) Drug
- Placebo capsule to match Add-back capsule Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 50 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 4, 2020
- Primary completion
- Sep 14, 2022
- Completion
- Dec 14, 2022
- Last update posted
- Apr 1, 2025
2020 – 2022
United States locations
- U.S. sites
- 8
- U.S. states
- 7
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Choice Research, LLC/ ID # 609 | Dothan | Alabama | 36303 | — |
| Universal Axon - Homestead, LLC/ ID # 620 | Homestead | Florida | 33030 | — |
| Stedman Clinical Trials/ ID # 612 | Tampa | Florida | 33613 | — |
| Advanced Specialty Research/ ID # 610 | Nampa | Idaho | 83687 | — |
| Women's & Family Care, LLC dba GTC Research/ ID # 608 | Shawnee Mission | Kansas | 66218 | — |
| Southern Clinical Research / ID # 611 | Metairie | Louisiana | 70001 | — |
| Chattanooga Medical Research LLC/ ID# 602 | Chattanooga | Tennessee | 37404 | — |
| Tanner Clinic/ ID # 624 | Layton | Utah | 84041 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 39 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04335591, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 1, 2025 · Synced Jul 21, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04335591 live on ClinicalTrials.gov.