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Clinical Study to Evaluate Efficacy and Safety of TAK-385 40 mg Compared With Leuprorelin in Patients With Endometriosis

NCT03931915 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 335

Last updated 2020-12-11

No results posted yet for this study

Summary

The objective is to evaluate the efficacy and safety of TAK-385 40 mg orally administrated once daily for 24 weeks compared with Leuprorelin \[once/4 weeks, 3.75 or 1.88 mg subcutaneously (SC)/time\] in patients with endometriosis.

Conditions

  • Endometriosis

Interventions

DRUG

TAK-385

TAK-385 40 mg tablets + Leuprorelin acetate placebo injection

DRUG

Leuprorelin acetate

TAK-385 placebo tablets + Leuprorelin acetate 1.88 mg / 3.75 mg injection

Sponsors & Collaborators

  • ASKA Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-08
Primary Completion
2020-06-12
Completion
2020-09-28

Countries

  • Japan

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 NCT03931915 on ClinicalTrials.gov