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Terminated Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT04372121

Public ClinicalTrials.gov record NCT04372121. 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.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 11:56 AM EDT

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04372121
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Lead sponsor
Kissei Pharmaceutical Co., Ltd.
Industry
Enrollment
30 participants

Conditions and interventions

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 23, 2020 (Actual)
Primary completion
Jan 8, 2021 (Actual)
Completion
Feb 16, 2021 (Actual)
Last update posted
Apr 2, 2025

2020 – 2021

United States locations

U.S. sites
23
U.S. states
10
U.S. cities
20
Facility City State ZIP Site status
Applied Res Center of Ar / Id # 735 Little Rock Arkansas 72212 —
Futura Research, Inc. / ID # 781 Norwalk California 90650 —
Adv Womens Health Institute / ID # 761 Greenwood Village Colorado 80111 —
Red Rocks OB/GYN / ID # 732 Lakewood Colorado 80228 —
Dr. David I. Lubetkin, LLC / ID # 703 Boca Raton Florida 33486 —
Coral Way Research / ID # 799 Miami Florida 33135 —
La Salud Research Clinic, Inc. / ID # 824 Miami Florida 33155 —
A Premier Medical Research of Florida, LLC / ID # 752 Orange City Florida 32763 —
Clinical Associates of Orlando, LLC / ID # 779 Orlando Florida 32806 —
Providea Health Partners LLC / ID # 734 Evergreen Park Illinois 60805 —
Onyx Clinical Research / ID # 793 Flint Michigan 48532 —
Valley OBGYN / ID # 704 Saginaw Michigan 48602 —
ClinOhio Res Services, LLC / ID # 722 Columbus Ohio 43213 —
Complete Healthcare for Women / ID # 801 Columbus Ohio 43213 —
Hilltop OBGYN / ID # 711 Franklin Ohio 45005 —
Clinical Research Associates Inc / ID # 802 Nashville Tennessee 37203 —
Austin Area ObGyn PLLC / ID # 701 Austin Texas 78758 —
OB/GYN North Austin / ID # 764 Austin Texas 78758 —
HCWC dba DiscoveryClinical Trials / ID # 771 Dallas Texas 75231 —
Signature Gyn Services / ID # 726 Fort Worth Texas 76104 —
Medical Colleagues of Texas / ID # 819 Katy Texas 77450 —
Maximos OB/GYN League City Texas 77573 —
Physicians Research Options / ID # 766 Draper Utah 84020 —

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 2 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04372121, 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 2, 2025 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04372121 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →