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

NCT05445167 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2025-11-25

No results posted yet for this study

Summary

Multi-center, randomized, double-blind, parallel-group study to confirm superiority of KLH-2109 to placebo in uterine fibroids patient with menorrhagia and pain

Conditions

  • Uterine Fibroids (MeSH Heading: Leiomyoma)

Interventions

DRUG

KLH-2109

Oral administration

DRUG

Placebo

Oral 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
2024-02-16
Completion
2024-02-16

Countries

  • Japan

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Entities

Drugs

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 NCT05445167 on ClinicalTrials.gov