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Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain.

Primary Purpose

Endometriosis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

75 mg linzagolix tablet

200 mg linzagolix tablet

Add-back capsule (E2 1 mg / NETA 0.5 mg)

Placebo tablet to match 75 mg linzagolix tablet

Placebo tablet to match 200 mg linzagolix tablet

Placebo capsule to match Add-back capsule

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring Dysmenorrhea, Dyspareunia, Dyschezia, Non-menstrual pelvic pain

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

The subject must have:

Her most recent surgical and - if available - histological diagnosis of pelvic endometriosis up to 10 years before screening.
Moderate to severe endometriosis-associated pain during the screening period.
Regular menstrual cycles.
BMI ≥ 18 kg/m2 at the screening visit. -

Exclusion Criteria:

The subject will be excluded if she:

Is pregnant or breast feeding or is planning a pregnancy within the duration of the treatment period of the study.
Is less than 6 months postpartum or 3 months postabortion/ miscarriage at the time of entry into the screening period.
Has had a surgical history of any major abdominal surgery within 6 months or any interventional surgery for endometriosis performed within a period of 2 months before screening.
Did not respond to prior treatment with GnRH agonists or GnRH antagonists for endometriosis.
Has a history of, or known, osteoporosis or other metabolic bone disease.
Has chronic pelvic pain that is not caused by endometriosis and requires chronic analgesic or other chronic therapy which would interfere with the assessment of endometriosis-associated pain.

Sites / Locations

Achieve Clinical Research/ ID # 601
Choice Research, LLC/ ID # 609
Southeast Clinical Research/ ID # 618
Universal Axon - Homestead, LLC/ ID # 620
Multi-Specialty Research Associates, Inc./ ID # 625
Wellington Anti-Aging, LLC/ ID # 613
Adventura Clinical Research/ ID # 616
Stedman Clinical Trials/ ID # 612
Advanced Specialty Research/ ID # 610
Affinity Clinical Research Institute/ ID # 622
Women's & Family Care, LLC dba GTC Research/ ID # 608
Southern Clinical Research / ID # 611
Quad Clinical Research LLC/ ID # 615
The Center for Women's Health & Wellnes/ ID # 603
PMG Research of Wilmington/ ID # 614
UWCR - Lyndhurst Clinical Researc/ ID# 605
Obstetrics & Gynecology Associates, Inc./ ID# 606
Invocare Medical Research & Healthcare Center/ ID # 607
Chattanooga Medical Research LLC/ ID# 602
Next Innovative Clinical Research/ ID # 617
Storks Research, LLC/ ID # 623
Tanner Clinic/ ID # 624
Salzburger Landeskliniken / ID # 105
AKH Vienna University of Medicine Vienna / ID # 101
AKH Vienna University of Medicine Vienna/ ID # 103
Multiprofile Hospital for Active Treatment Sliven/ ID # 131
MHAT Dr. Bratan Shukerov / ID #138
Medical Centre Excelsior /ID # 135
Group Practice for Specialized Medical Assistance in GINART/ ID # 132
Multiprofile Hospital for Active Treatment St. Sofia/ ID # 137
University Multiprofile Hospital for Active Treatment "Sofiamed"/ ID # 133
MUDr Jan Drahonovsky, Ustav pro peci o matku a dite/ ID #163
Gynekologicko - Porodnicka Ambulance/ ID # 162
Gynekologie MU Dr.Lubomir Mikulasek / ID # 160
CHRU Besançon Hopital/ ID # 204
CHRU Strasbourg - Hopital Hautepierre/ ID # 205
Clinique Pasteur / ID # 206
Principal SMO Kft/ ID # 250
Róbert Károly Magánkórház/ ID # 253
Szent Anna Szuleszeti-Nogyogyaszati/ ID # 251
Mediroyal Prevencios Kozpont/ ID # 252
Lubelskie Centrum Diagnostyczne/ ID # 402
Prywatna Klinika Ginekologiczno - Położnicza/ ID # 404
VITA LONGA Sp. z o.o./ ID # 408
Clinical Medical Research sp. Z o. O/ ID # 406
Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof Wilk/ ID # 411
Niepubliczny Zaklad Opieki Zrowotnej GynCentrum/ ID # 407
Kotarski Jan Specjalistyczny Gabinet Ginekologiczno Polozniczy/ ID # 405
Centrum Medyczne Chodźki Lublin/ ID # 403
Centrum Ginekologii Endokrynologii i Medycyny Rozrodu "Artemida"/ ID # 409
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu/ ID # 410
Specjalistyczny Gabinet Lekarski Krzysztof Dynowski / ID # 401
Quantum Medical Center SRL/ ID # 353
Spitalul Clinic "Nicolae Malaxa"/ ID # 352
Centrul Medical EUROMED/ ID # 351
Sp Cl de Obstetrica si Ginecologie "Prof. Dr. Panait Sirbu"/ ID # 354
Gine Plus SRL Cluj- Napoca/ ID # 357
Centrul Medical GALENUS/ ID # 355
Hospital General Universitario Reina Sofia/ ID # 304
Hospital Regional Universitario de Málaga/ ID # 303
City clinical maternity hospital №1/ ID # 502
Ivano-Frankivsk regional perinatal center, Family planning center/ ID # 506
Kyiv City Maternity Hospital #6/ ID # 504
Medical center of LLC "Medical Center "Verum"/ ID # 503
Institute of Pediatrics Obstetrics and Gynecology/ ID # 508
Kyiv City Clinical Hospital #9/ ID # 501
Kyiv City Center of Reproductive and Perinatal Medicine/ ID # 509
Ternopil' Communal City Hospital #2/ ID # 511
Vinnytsia City Clinical Hospital "Center of Mother and the Child "/ ID # 510
Zaporizhzhya Regional Clinical Hospital/ ID # 505
Maternity Hospital № 3/ ID # 507

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Linzagolix 75 mg

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

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Dysmenorrhea

Change at Month 3 from baseline in the mean daily assessment of dysmenorrhea measured on a 0-3 Verbal Rating Scale (VRS) using an electronic diary. The lower value represents a better outcome.

Non-menstrual pelvic pain

Change at Month 3 from baseline in the mean daily assessment of non-menstrual pelvic pain measured on a 0-3 Verbal Rating Scale (VRS) using an electronic diary. The lower value represents a better outcome.

Secondary Outcome Measures

Dysmenorrhea

Change from baseline to Month 6 in dysmenorrhea measured on a 0-3 Verbal Rating Scale (VRS) using an electronic diary. The lower value represents a better outcome.

Non-menstrual pelvic pain

Change from baseline to Month 6 in non-menstrual pelvic pain measured on a 0-3 Verbal Rating Scale (VRS) using an electronic diary. The lower value represents a better outcome

Dyschezia

Change from baseline to Month 6 in dyschezia measured on a 0-10 Numeric Rating Scale (NRS) using an electronic diary. The lower value represents a better outcome.

Overall Pelvic Pain

Change from baseline to Month 6 in overall pelvic pain measured on a 0-10 Numeric Rating Scale (NRS) using an electronic diary. The lower value represents a better outcome.

Interference of pain with the ability to perform daily activities

Change from baseline to Month 6 in the interference of pain with the ability to perform daily activities, measured using the pain dimension of the Endometriosis Health Profile-30 (EHP-30) using an electronic diary

Dyspareunia

Change from baseline to Month 6 in dyspareunia measured on a 0-3 Verbal Rating Scale (VRS) using an electronic diary. The lower value represents a better outcome.

No analgesic use for endometriosis associated pain

Proportion of subjects reporting no analgesic use for endometriosis associated pain, during the preceding 4-week period at Month 6

No opiate use for endometriosis associated pain

Proportion of subjects reporting no opiate use for endometriosis associated pain, during the preceding 4-week period at Month 6

Full Information

NCT ID

NCT03992846

First Posted

June 18, 2019

Last Updated

January 12, 2023

Sponsor

Kissei Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03992846

Brief Title

Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain.

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

June 13, 2019 (Actual)

Primary Completion Date

October 18, 2021 (Actual)

Study Completion Date

April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kissei Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

Detailed Description

This is a prospective, randomized, double-blind, placebo-controlled study to demonstrate the efficacy and safety of linzagolix administered orally once daily at doses of 75 mg alone and 200 mg in combination with low dose ABT (E2 1 mg/NETA 0.5 mg) versus placebo in the management of moderate to severe EAP in 450 women. Eligible subjects who have completed the 6-month treatment period may enter a separate extension study for 6 additional months of active treatment (no placebo control). Subjects who do not continue in the extension study will enter a 6 month treatment-free follow-up phase.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endometriosis

Keywords

Dysmenorrhea, Dyspareunia, Dyschezia, Non-menstrual pelvic pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

486 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Linzagolix 75 mg

Arm Type

Experimental

Arm Title

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

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

75 mg linzagolix tablet

Intervention Description