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A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia

NCT05440383 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 287

Last updated 2025-03-14

No results posted yet for this study

Summary

Multi-center, randomized, double-blind, parallel-group study to confirm non-inferiority of KLH-2109 to Leuprorelin acetate in uterine fibroids patient with menorrhagia

Conditions

  • Uterine Fibroids (MeSH Heading: Leiomyoma)

Interventions

DRUG

KLH-2109

Oral administration

DRUG

Leuprorelin

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
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-11
Primary Completion
2024-08-21
Completion
2024-08-21

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 NCT05440383 on ClinicalTrials.gov