A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Elagolix in Patients With Moderate to Severe Endometriosis-Associated Pain

Qilu Pharmaceutical (Hainan) Co., Ltd.1 site in 1 country336 target enrollmentSeptember 4, 2022

ConditionsEndometriosis

InterventionsElagolix Elagolix placebo

DrugsElagolix Elagolix placebo

Overview

Phase: Phase 3
Intervention: Elagolix
Conditions: Endometriosis
Sponsor: Qilu Pharmaceutical (Hainan) Co., Ltd.
Enrollment: 336
Locations: 1
Primary Endpoint: Percentage of Responders of Non-Menstrual Pelvic Pain (NMPP) at week 12
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Detailed Description

This is a Phase 3, multicenter, double-blind, placebo-controlled, randomized study to assess the safety and efficacy of elagolix versus placebo in premenopausal 18 to 49 year old women with moderate to severe endometriosis-associated pain. Participants will be randomised in a 1:1 ratio to receive either elagolix ( 200mg )or placebo. Participants will be administered the study drug up to month 6.

Registry

clinicaltrials.gov

Start Date

September 4, 2022

End Date

February 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Qilu Pharmaceutical (Hainan) Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participant understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent.
•Participant is premenopausal female, between 18 and 49 years of age (both inclusive), regular menstruation within 3 months before screening.
•Participant clinical diagnosis of endometriosis (laparoscopy or laparotomy) performed within 10 years of entry into Screening.
•Participant agrees to use non-hormonal contraception from signing the informed consent through 30 days after last dose of investigational product.
•Participant cervical smear is normal or abnormal without clinical significance (normal cervical smear within 6 months prior to screening; or participant is virgin and decides not to undergo cervical smear); Atypical Squamous Cells of Undetermined Significance (ASCUS) may be combined with human papillomavirus (HPV) testing. ASCUS participants may be included if they are negative for high-risk HPV.
•Participant who is 40 years or older in age has a normal or abnormal without clinical significance mammogram at screening or within 6 months prior to screening \[Breast Imaging Reporting Data System (BI-RADS) classification 1-3 or equivalent\].

Exclusion Criteria

•Participant who has a history of sensitivity to elagolix or excipients.
•Participant who blood pregnancy test is positive at screening or on the day of randomization.
•Participant who has an intra-uterine device (IUD) or contraceptive sub-dermal implant (If the IUD or sub-dermal implant is removed at least 30 days, participant may be screened for the study).
•Participant who has a history of drug or alcohol abuse within 6 months of screening.
•Participant who is hepatitis B patient \[hepatitis B surface antigen (HbsAg) positive and detection of HBV-DNA suggests viral replication\]; hepatitis C patients \[hepatitis C virus (HCV) antibody positive and detection of HCV-RNA suggests viral replication\]; syphilis screening positive (except for specific antibody detection positive, non-specific antibody detection negative and confirmed as inactive infection in combination with clinical judgment), known history of human immunodeficiency virus (HIV) positive or HIV screening positive;
•Participant who has used moderate or strong inducers of cytochrome P450 3A or inhibitors of organic anion transporting polypeptide 1B1 (OATP1B1) within 30 days prior to first dose.
•Participant who has unstable medical diseases in the opinion of the investigator (e.g. uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled seizures, angina unstable, inflammatory bowel disease, hyperprolactinemia, malignancy, or significant infection).
•Participant who has a history of major depression or post-traumatic stress disorder within 2 years of screening or a history of other major psychiatric disorder.
•Participant who has a history of surgical history of hysterectomy, bilateral oophorectomy, procedure that interferes with gastrointestinal mo
•Participant who in the opinion of the investigator has a history of previous non-response to gonadotropin-releasing hormone agonists, antagonists. tility, any recent major or minor surgery.