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

A Phase III Confirmatory Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia

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

Study Overview

• Status: Active, not recruiting
• Conditions: Uterine Fibroids (MeSH Heading: Leiomyoma)
• Intervention / Treatment: Drug: KLH-2109; Drug: Leuprorelin

• Study Type: Interventional
• Enrollment (Estimated): 264
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Kissei Pharmaceutical Co., Ltd.; Phone Number: Email only; Email: rinsyousiken@pharm.kissei.co.jp

Study Locations

• Japan
  • Multiple Locations, Japan
    • Clinical Resarch Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Premenopausal Japanese woman diagnosed with uterine fibroids
• Patients confirmed by transvaginal ultrasonography to have at least 1 myoma that meet all of the following conditions:
• Larger than a certain standard
• No calcification
• Not receiving surgical treatment
• Patients with a normal menstrual cycle
• Patients diagnosed with menorrhagia

Exclusion Criteria:

• Patients with complication or history of blood system diseases (salasemia, sickle erythrocyte anemia, folic acid deficiency, coagulation disorder, etc.) (excluding iron deficiency anemia and latent iron deficiency anemia)
• Patients with lower abdominal pain due to irritable bowel syndrome or lower abdominal pain due to severe interstitial cystitis
• Patients with undiagnosed abnormal genital bleeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KLH-2109; Oral administration	Drug: KLH-2109; Oral administration
Active Comparator: Leuprorelin; Subcutaneous administration	Drug: Leuprorelin; Subcutaneous administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects with a total PBAC score of less than 10 from Week 6 to 12 after beginning of study drug administration	PBAC (pictorial blood loss assessment chart) score	Up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects with a total PBAC score of less than 10 from Week 2 to 6 after beginning of study drug administration	PBAC (pictorial blood loss assessment chart) score	Up to 24 weeks
Proportion of subjects with a total PBAC score of less than 10 from Week 18 to 24 after beginning of study drug administration	PBAC (pictorial blood loss assessment chart) score	Up to 24 weeks
Proportion of subjects with a total PBAC score of less than 10 during 6 weeks before end of study drug administration	PBAC (pictorial blood loss assessment chart) score	Up to 24 weeks
Change from baseline in blood hemoglobin	Hemoglobin	Up to 24 weeks
Change rate from baseline in myoma volume	Myoma volume	Up to 24 weeks
Change rate from baseline in uterine volume	Uterine volume	Up to 24 weeks
Change from baseline in UFS-QOL score	UFS-QOL (uterine fibroid symptom and QOL) score	Up to 24 weeks
Incidence of adverse events and adverse drug reactions	Adverse events and adverse drug reactions	Up to 24 weeks
Change rate from baseline in bone metabolic markers (BAP and serum NTx)	Bone metabolic markers (BAP and serum NTx)	Up to 24 weeks
Change rate from baseline in bone density (DXA)	Bone density, T-score	Up to 24 weeks

Collaborators and Investigators

• Sponsor: Kissei Pharmaceutical Co., Ltd.
• Investigators: Study Director: Yoshitaka Shimizu, Kissei Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2022
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Uterine Diseases; Hemorrhage; Connective Tissue Diseases; Neoplasms, Connective Tissue; Menstruation Disturbances; Neoplasms, Muscle Tissue; Uterine Hemorrhage; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Leiomyoma; Myofibroma; Menorrhagia; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Leuprolide
• Other Study ID Numbers: KLH2301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No