A Clinical Trial to Evaluate Efficacy and Safety of Elagolix Tablets in Women With Moderate or Severe Endometriosis-associated Pain

Sponsor
Nanjing Chia-tai Tianqing Pharmaceutical
Study ID
NCT06076486
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Elagolix — DRUG
    Elagolix 200 mg tablets administered orally BID
  • Elagolix placebo — DRUG
    Elagolix placebo administered orally BID

Study Details

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.

Key Dates

Start date
Sep 14, 2023
Status verified
Apr 2025
Primary completion
Nov 22, 2024
Completion
Apr 2, 2025

Study Design

Enrollment
202 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Elagolix 200 mg BID
    Participants received elagolix 200 mg tablets twice a day (BID)
  • Placebo Comparator: Elagolix placebo
    Participants received elagolix placebo twice a day (BID)

Primary Outcome Measure

Percentage of responders of dysmenorrhea (DYS) at week 12 [ Time Frame: 12 weeks ]

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