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

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

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

Study Overview

• Status: Completed
• Conditions: Uterine Fibroids (MeSH Heading: Leiomyoma)
• Intervention / Treatment: Drug: Placebo; Drug: KLH-2109

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Multiple Locations, Japan
    • Clinical Research 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
• Patients with pain symptoms associated with uterine fibroids

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
Placebo Comparator: Placebo	Drug: Placebo; Oral administration
Experimental: KLH-2109	Drug: KLH-2109; Oral 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
Proportion of women with a maximum NRS for pain score of 1 or less during 28 days before the end of study drug administration	NRS (numeric rating scale) for pain	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 12 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 12 weeks
Proportion of subjects with a maximum NRS score of 1 or less for pain symptoms every 28 days	NRS (numerical rating scale)	Up to 12 weeks
Proportion of subjects with maximum NRS score of zero for pain symptoms during 28 days before end of study drug administration	NRS (numerical rating scale)	Up to 12 weeks
Proportion of subjects with a maximum NRS score of zero for pain symptoms every 28 days	NRS (numerical rating scale)	Up to 12 weeks
Average NRS score every 28 days for pain symptoms	NRS (numerical rating scale)	Up to 12 weeks
Percentage of asymptomatic days (number of the days with NRS score of zero for pain symptoms) during 28 days before end of study drug administration	NRS (numerical rating scale)	Up to 12 weeks
Percentage of asymptomatic days (number of the days with NRS score of zero for pain symptoms) every 28 days	NRS (numerical rating scale)	Up to 12 weeks
Incidence of adverse events and adverse drug reactions	Adverse events and adverse drug reactions	Up to 12 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 (Actual): February 16, 2024
• Study Completion (Actual): February 16, 2024

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: June 30, 2022
• First Posted (Actual): July 6, 2022

Study Record Updates

• Last Update Posted (Estimated): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Neoplasms, Muscle Tissue; Leiomyoma; linzagolix
• Other Study ID Numbers: KLH2302

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