NCT03992846|CompletedPhase 3ResultsDMCFDA Drug

Efficacy and Safety of Linzagolix for the Treatment of 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

Compare

1 other identifier

18-OBE2109-003

Study Type

interventional

Target

486

Locations

10 countries

Sites

Timeline

RegisteredJun 2019

StartedJun 2019

CompletionApr 2022

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

On Track

Trial Health Score

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

Enrollment

486

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Jun 2019

Typical duration for phase_3

Geographic Reach

10 countries

71 active sites

Status

completed

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

2.8 years study duration

Study Start

First participant enrolled

June 13, 2019

Completed

5 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2019

Completed

2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2019

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2021

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed

2.2 years until next milestone

Results Posted

Study results publicly available

May 29, 2024

Completed

Last Updated

April 2, 2025

Status Verified

June 1, 2022

Enrollment Period

2.4 years

First QC Date

June 18, 2019

Results QC Date

April 3, 2024

Last Update Submit

March 25, 2025

Conditions

Endometriosis

Keywords

DysmenorrheaDyspareuniaDyscheziaNon-menstrual pelvic pain

Outcome Measures

Primary Outcomes (2)

Reduction of Dysmenorrhea (DYS) at Month 3 - Proportion of Responders
Percentage of subjects with reduction of 1.1 for DYS in mean pelvic pain score within last 28 days prior to Month 3 or discontinuation, and stable or decreased use of analgesics for Endometriosis-associated pain (=EAP) within the same calendar days.
Baseline to Month 3
Reduction of Non-menstrual Pelvic Pain (NMPP) at Month 3 - Proportion of Responders
Percentage of subjects with reduction of 0.8 for NMPP in mean pelvic pain score within last 28 days prior to Month 3 or discontinuation, and stable or decreased use of analgesics for Endometriosis-associated pain (=EAP) within the same calendar days.
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