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

NCT05648669 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 336

Last updated 2022-12-13

No results posted yet for this study

Summary

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.

Conditions

  • Endometriosis

Interventions

DRUG

Elagolix

200 mg tablet

DRUG

Elagolix placebo

Elagolix-matched Placebo tablet

Sponsors & Collaborators

  • Qilu Pharmaceutical (Hainan) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • jinhua Leng · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-04
Primary Completion
2023-07-31
Completion
2024-02-29

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05648669 on ClinicalTrials.gov