NCT04372121|TerminatedPhase 3ResultsDMCFDA Drug

Study 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.

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

EDELWEISS 5

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

Kissei Pharmaceutical Co., Ltd.ClinicalTrials.gov

Compare

1 other identifier

19-OBE2109-005

Study Type

interventional

Target

Locations

3 countries

Sites

Timeline

RegisteredMay 2020

StartedMar 2020

CompletionFeb 2021

Brief 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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

Completed

Started Mar 2020

Shorter than P25 for phase_3

Geographic Reach

3 countries

25 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

11 months study duration

Study Start

First participant enrolled

March 23, 2020

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

April 29, 2020

Completed

2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2020

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2021

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2021

Completed

4.1 years until next milestone

Results Posted

Study results publicly available

March 19, 2025

Completed

Last Updated

April 2, 2025

Status Verified

December 1, 2021

Enrollment Period

10 months

First QC Date

April 29, 2020

Results QC Date

April 4, 2024

Last Update Submit

March 25, 2025

Conditions

Endometriosis

Keywords

DysmenorrheaDyspareuniaDyscheziaNon-menstrual pelvic pain

Outcome Measures

Primary Outcomes (2)

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.
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.
6 Months

Study Arms (2)

Linzagolix 75 mg

EXPERIMENTAL

Drug: 75 mg linzagolix tabletDrug: Placebo tablet to match 200 mg linzagolix tabletDrug: Placebo capsule to match Add-back capsule

Linzagolix 200 mg + Add-back (E2 1 mg / NETA 0.5 mg)

EXPERIMENTAL

Drug: 200 mg linzagolix tabletDrug: Add-back capsule (E2 1 mg / NETA 0.5 mg)Drug: Placebo tablet to match 75 mg linzagolix tablet