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A Clinical Study of KLH-2109 in Patients With Endometriosis

NCT07015268 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2026-03-02

No results posted yet for this study

Summary

To verify the non-inferiority of KLH-2109 to leuprorelin acetate in a double-blind manner in terms of efficacy in endometriosis patients with pelvic pain.

Conditions

  • Endometriosis

Interventions

DRUG

KLH-2109

\- KLH-2109 tablet: Oral administration \- Leuprorelin acetate placebo: Subcutaneous administration

DRUG

Leuprorelin acetate

\- KLH-2109 placebo tablet: Oral administration \- Leuprorelin acetate: Subcutaneous administration

Sponsors & Collaborators

  • Kissei Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yoshitaka Shimizu · Kissei Pharmaceutical Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-09
Primary Completion
2027-11-30
Completion
2027-11-30

Countries

  • Japan

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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 NCT07015268 on ClinicalTrials.gov