A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Elagolix Tablets in Patients With Moderate or Severe Endometriosis-associated Pain

Nanjing Chia-tai Tianqing Pharmaceutical1 site in 1 country202 target enrollmentSeptember 14, 2023

ConditionsEndometriosis

InterventionsElagolix placebo Elagolix

DrugsElagolix Elagolix placebo

Overview

Phase: Phase 3
Intervention: Elagolix placebo
Conditions: Endometriosis
Sponsor: Nanjing Chia-tai Tianqing Pharmaceutical
Enrollment: 202
Locations: 1
Primary Endpoint: Percentage of responders of Non-Menstrual Pelvic Pain (NMPP) at week 12
Status: Completed
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase 3, multicenter, double-blind, placebo-controlled, randomized study to evaluate the efficacy and safety of elagolix tablets versus placebo in premenopausal women with moderate or severe endometriosis-associated pain.

Registry

clinicaltrials.gov

Start Date

September 14, 2023

End Date

April 2, 2025

Last Updated

7 months ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Nanjing Chia-tai Tianqing Pharmaceutical

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent.
•Diagnosis of endometriosis by pathological diagnosis or surgery within 10 years prior to screening by laparoscopy or exploratory laparotomy; or diagnosis of endometriosis based on clinical presentation of endometriosis in combination with previous imaging studies according to Endometriosis Diagnosis and Treatment Guidelines (Third Edition).
•Premenopausal female aged 18 and 49 years (both inclusive) with one complete menstruation prior to screening record in the diary for at least 35 days and at least one complete menstrual cycle before the first dosing.
•Agree to take only protocol-specified permitted rescue analgesic medications during the screening and treatment Periods.
•Cervical smear is normal or abnormal without clinical significance (acceptance of normal cervical smear within 6 months prior to screening; or participant is virgin and decides not to take cervical smear); ASCUS may be combined with HPV testing. ASCUS participants may be included if they are negative for high-risk HPV.
•Agree to use non-hormonal contraception from signing the informed consent through 1 month after last dosing.

Exclusion Criteria

•Subjects with a history of sensitivity to elagolix or excipients; or with a known history of serious, life-threatening or significant allergy to any drug.
•Previous non-responders to GnRH agonist or GnRH antagonist therapy as judged by the investigator.
•Subjects with a history of previous or existing osteoporosis or other metabolic bone disease; or previous abnormal clinically significant hypocalcemia, hypophosphatemia or hyperphosphatemia; or DXA Z score (subjects \< 40 years old) or T score (subjects ≥ 40 years old) of lumbar spine (L1-L4), femoral neck or total hip BMD is \< -2.0;
•Subjects with unstable diseases (such as poorly controlled diabetes, poorly controlled hypertension, poorly controlled seizures, unstable angina pectoris, inflammatory bowel disease, hyperprolactinemia, malignant tumors (except basal cell carcinoma of the skin) or severe infection, etc.) unuitable for the study at screening as judged by the investigators;
•Subjects with a history of hysterectomy, oophorectomy, or surgery affecting drug absorption; or those who plan to undergo the above surgery during the trial;
•Subjects with a history of major depressive disorder or post-traumatic stress disorder within 2 years prior to screening or other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder); or history of suicidal behavior or suicidality; or suicidality as judged by the investigators;
•Subjects with undiagnosed vaginal and/or uterine bleeding within 3 months prior to screening;
•Subjects with other chronic pain syndromes requiring chronic analgesia or other long-term treatment that would be expected to interfere with the assessment of endometriosis-related pain;
•Subjects with a history of drug or alcohol abuse within 6 months prior to screening;
•Subjects aged ≥ 40 years with abnormal results of breast ultrasonography during the screening period or within 1 year prior to screening (BI-RADS classification grade 4 and above);

Arms & Interventions

Elagolix placebo

Participants received elagolix placebo twice a day (BID)

Intervention: Elagolix placebo

Elagolix 200 mg BID

Participants received elagolix 200 mg tablets twice a day (BID)

Intervention: Elagolix

Outcomes

Primary Outcomes

Percentage of responders of Non-Menstrual Pelvic Pain (NMPP) at week 12

Time Frame: 12 weeks

The responder was defined as reaching a pre-defined threshold.

Percentage of responders of dysmenorrhea (DYS) at week 12

Time Frame: 12 weeks

The responder was defined as reaching a pre-defined threshold.

Secondary Outcomes

Change from baseline in NMPP(Through study completion, an average of 24 weeks)
Change from baseline in Numeric Rating Scale (NRS) scores(Through study completion, an average of 24 weeks)
Safety Specifications in the Treatment Period(Through study completion, an average of 24 weeks)
Change from baseline in DYS(Through study completion, an average of 24 weeks)
Change from baseline in rescue analgesic use(Through study completion, an average of 24 weeks)
Percentage of participants with a Patient Global Impression of Change (PGIC) response(Through study completion, an average of 24 weeks)
Change from baseline in Dyspareunia (DYSP)(Through study completion, an average of 24 weeks)