A Study to Evaluate Safety and Efficacy of Elagolix in Patients With Moderate to Severe Endometriosis-Associated Pain

Sponsor
Qilu Pharmaceutical (Hainan) Co., Ltd.
Study ID
NCT05648669
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 49 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 4, 2022
Status verified
Nov 2022
Primary completion
Jul 31, 2023
Completion
Feb 29, 2024

Study Design

Enrollment
336 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Elagolix
    Elagolix 200 mg twice daily (BID) for the 6-month Treatment Period
  • Placebo Comparator: Elagolix placebo
    Placebo BID for the 6-month Treatment Period

Primary Outcome Measure

Percentage of Responders of Dysmenorrhea (DYS) at week 12 [ Time Frame: Week12 ]

Central Contacts

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