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

Phase 3

Completed

• Conditions: Uterine Fibroids (MeSH Heading: Leiomyoma)
• Interventions: Drug: Leuprorelin; Drug: KLH-2109

• Registration Number: NCT05440383
• Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-27
• Study First Submitted QC: 2022-06-27
• Study First Posted: 2022-06-30
• Study Start: 2022-10-11
• Primary Completion: 2024-08-21
• Study Completion: 2024-08-21
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 287

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Leuprorelin	Leuprorelin	Subcutaneous administration
KLH-2109	KLH-2109	Oral administration

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change rate from baseline in myoma volume	Up to 24 weeks	Myoma volume
Incidence of adverse events and adverse drug reactions	Up to 24 weeks	Adverse events and adverse drug reactions
Change from baseline in blood hemoglobin	Up to 24 weeks	Hemoglobin
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	PBAC (pictorial blood loss assessment chart) score
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	PBAC (pictorial blood loss assessment chart) score
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	PBAC (pictorial blood loss assessment chart) score
Change from baseline in UFS-QOL score	Up to 24 weeks	UFS-QOL (uterine fibroid symptom and QOL) score
Change rate from baseline in bone metabolic markers (BAP and serum NTx)	Up to 24 weeks	Bone metabolic markers (BAP and serum NTx)
Change rate from baseline in uterine volume	Up to 24 weeks	Uterine volume
Change rate from baseline in bone density (DXA)	Up to 24 weeks	Bone density, T-score

Trial Locations

Locations (1)

Clinical Resarch Site; 🇯🇵 Multiple Locations, Japan