NCT05440383

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
287

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 30, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

October 11, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2024

Completed
Last Updated

March 14, 2025

Status Verified

March 1, 2025

Enrollment Period

1.9 years

First QC Date

June 27, 2022

Last Update Submit

March 12, 2025

Conditions

Uterine Fibroids (MeSH Heading: Leiomyoma)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Proportion of subjects with a total PBAC score of less than 10 from Week 2 to 6 after beginning of study drug administration

    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

    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

    Up to 24 weeks

  • Change from baseline in blood hemoglobin

    Up to 24 weeks

  • Change rate from baseline in myoma volume

    Up to 24 weeks

  • +5 more secondary outcomes

Study Arms (2)

KLH-2109

EXPERIMENTAL

Oral administration

Drug: KLH-2109

Leuprorelin

ACTIVE COMPARATOR

Subcutaneous administration

Drug: Leuprorelin

Interventions

KLH-2109DRUG

Oral administration

KLH-2109
LeuprorelinDRUG

Subcutaneous administration

Leuprorelin

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Resarch Site

Multiple Locations, Japan

Location

MeSH Terms

Conditions

Leiomyoma

Interventions

linzagolixLeuprolide

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Yoshitaka Shimizu

    Kissei Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2022

First Posted

June 30, 2022

Study Start

October 11, 2022

Primary Completion

August 21, 2024

Study Completion

August 21, 2024

Last Updated

March 14, 2025

Record last verified: 2025-03

Locations

JP(1)