Clinical Trials Logo
  1. Home
  2. Endometriosis
  3. NCT04335591

Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain (EDELWEISS 6)

Endometriosis Clinical Trial

Official title:
A Double-blind Randomized Extension Study to Assess the Long-term Efficacy and Safety of Linzagolix in Subjects With Endometriosis-associated Pain

Clinical 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 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04335591
Study type Interventional
Source Kissei Pharmaceutical Co., Ltd.
Contact
Status Completed
Phase Phase 3
Start date March 5, 2020
Completion date December 15, 2022
View Details
See also
  Status Clinical Trial Phase
Completed NCT01931670 - A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain Phase 3
Recruiting NCT05648669 - A Study to Evaluate Safety and Efficacy of Elagolix in Patients With Moderate to Severe Endometriosis-Associated Pain Phase 3
Completed NCT04081532 - The Effectiveness of Laparoscopic Treatment of Superficial Endometriosis for Managing Chronic Pelvic Pain N/A
Recruiting NCT06101303 - Endometriosis Pain
Completed NCT04665414 - Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI
Completed NCT03690765 - Study of Real Clinical Practice to Evaluate the Effects of Oral Dydrogesterone for Treatment of Confirmed Endometriosis
Recruiting NCT05153512 - ADOlescent DysmenoRrhea Endometriosis Assessment Magnetic Resonance Imaging (Adodream)
Active, not recruiting NCT04171297 - Ultrasound Evaluation of the Pelvis in Women With Suspected Endometriosis Scheduled for Laparoscopic Surgery
Recruiting NCT04172272 - The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures N/A
Completed NCT04565470 - Strategies of Self-management of Endometriosis Symptoms
Completed NCT03613298 - Treatment by HIFU With Focal One® of Posterior Deep Infiltrating Endometriosis Lesions With Intestinal Involvement. N/A
Withdrawn NCT05568940 - Evaluating Tibolone Add-back in Patients With Endometriosis and Fibroids
Not yet recruiting NCT03464799 - Does Immunotherapy Have a Role in the Management of Endometriosis?
Active, not recruiting NCT03002870 - Characteristics of Patient Population With Endometriosis N/A
Completed NCT02973854 - Activation of the Sphingosine-1-phosphate (S1P) to S1P1 Receptor Subtype (S1PR1) Axis in Patients With Endometriosis: Identification of Potential Relevant Biomarkers to Diagnose and Treat
Withdrawn NCT03272360 - Endometriosis Biomarker Discovery Study N/A
Recruiting NCT02481739 - Laparoscopic Surgical Management of Endometriosis on Fertility N/A
Active, not recruiting NCT02754648 - Three Different Laparoscopic Approaches for Ovarian Endometrioma and the Effect on Ovarian Reserve N/A
Completed NCT06106932 - GnRH-a on Angiogenesis of Endometriosis N/A
Completed NCT02387931 - Supplementation in Adolescent Girls With Endometriosis Phase 4