NCT03986944|TerminatedPhase 3ResultsDMCFDA Drug

Study Stopped

Study halted due to the significant enrollment challenges encountered since its beginning. Screening and enrollment have been impacted by the COVID pandemic and more importantly by changes in the diagnosis and treatment of women with endometriosis.

A Phase 3 Study to Confirm the Efficacy and Safety of Linzagolix to Treat Endometriosis-associated Pain

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.

Kissei Pharmaceutical Co., Ltd.ClinicalTrials.gov

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1 other identifier

18-OBE2109-002

Study Type

interventional

Target

Locations

3 countries

Sites

112

Timeline

RegisteredJun 2019

StartedMay 2019

CompletionFeb 2021

Brief 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 management of moderate to severe endometriosis-associated pain (EAP).

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 May 2019

Geographic Reach

3 countries

112 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

1.7 years study duration

Study Start

First participant enrolled

May 23, 2019

Completed

14 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2019

Completed

8 days until next milestone

First Posted

Study publicly available on registry

June 14, 2019

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2021

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2021

Completed

3.7 years until next milestone

Results Posted

Study results publicly available

October 29, 2024

Completed

Last Updated

April 2, 2025

Status Verified

May 1, 2022

Enrollment Period

1.6 years

First QC Date

June 6, 2019

Results QC Date

March 18, 2024

Last Update Submit

March 25, 2025

Conditions

Endometriosis

Keywords

DysmenorrheaDyspareuniaDyscheziaNon-menstrual pelvic pain

Outcome Measures

Primary Outcomes (2)

Dysmenorrhea
Change at Month 3 from baseline in the mean daily assessment of dysmenorrhea (DYS) measured on a 4-point Verbal Rating Scale (VRS) using an electronicdiary * The 4-point VRS scale for DYS ranges from 0 to 3 (0: No pain; 1: Mild pain; 2: Moderate pain; 3: Severe pain). * A negative change in scores would be indicative of an improvement in the pain of DYS.
Baseline to Month 3
Non-menstrual Pelvic Pain
Change at Month 3 from baseline in the mean daily assessment of non-menstrual pelvic pain (NMPP) measured on a 4-point Verbal Rating Scale (VRS) using anelectronic diary * The 4-point VRS scale for NMPP ranges from 0 to 3 (0: No pain; 1: Mild pain; 2: Moderate pain; 3: Severe pain). * A negative change in scores would be indicative of an improvement in the NMPP.
Baseline to Month 3

Study Arms (3)

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

Placebo

PLACEBO COMPARATOR

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