A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia
Primary Purpose
Uterine Fibroids (MeSH Heading: Leiomyoma)
Status
Active
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
KLH-2109
Leuprorelin
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Fibroids (MeSH Heading: Leiomyoma)
Eligibility Criteria
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
Sites / Locations
- Clinical Resarch Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
KLH-2109
Leuprorelin
Arm Description
Oral administration
Subcutaneous administration
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
Change from baseline in blood hemoglobin
Hemoglobin
Change rate from baseline in myoma volume
Myoma volume
Change rate from baseline in uterine volume
Uterine volume
Change from baseline in UFS-QOL score
UFS-QOL (uterine fibroid symptom and QOL) score
Incidence of adverse events and adverse drug reactions
Adverse events and adverse drug reactions
Change rate from baseline in bone metabolic markers (BAP and serum NTx)
Bone metabolic markers (BAP and serum NTx)
Change rate from baseline in bone density (DXA)
Bone density, T-score
Full Information
NCT ID
NCT05440383
First Posted
June 27, 2022
Last Updated
September 19, 2023
Sponsor
Kissei Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05440383
Brief Title
A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia
Official Title
A Phase III Confirmatory Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 11, 2022 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kissei Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids (MeSH Heading: Leiomyoma)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
264 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
KLH-2109
Arm Type
Experimental
Arm Description
Oral administration
Arm Title
Leuprorelin
Arm Type
Active Comparator
Arm Description
Subcutaneous administration
Intervention Type
Drug
Intervention Name(s)
KLH-2109
Intervention Description
Oral administration
Intervention Type
Drug
Intervention Name(s)
Leuprorelin
Intervention Description
Subcutaneous administration
Primary Outcome Measure Information:
Title
Proportion of subjects with a total PBAC score of less than 10 from Week 6 to 12 after beginning of study drug administration
Description
PBAC (pictorial blood loss assessment chart) score
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Proportion of subjects with a total PBAC score of less than 10 from Week 2 to 6 after beginning of study drug administration
Description
PBAC (pictorial blood loss assessment chart) score
Time Frame
Up to 24 weeks
Title
Proportion of subjects with a total PBAC score of less than 10 from Week 18 to 24 after beginning of study drug administration
Description
PBAC (pictorial blood loss assessment chart) score
Time Frame
Up to 24 weeks
Title
Proportion of subjects with a total PBAC score of less than 10 during 6 weeks before end of study drug administration
Description
PBAC (pictorial blood loss assessment chart) score
Time Frame
Up to 24 weeks
Title
Change from baseline in blood hemoglobin
Description
Hemoglobin
Time Frame
Up to 24 weeks
Title
Change rate from baseline in myoma volume
Description
Myoma volume
Time Frame
Up to 24 weeks
Title
Change rate from baseline in uterine volume
Description
Uterine volume
Time Frame
Up to 24 weeks
Title
Change from baseline in UFS-QOL score
Description
UFS-QOL (uterine fibroid symptom and QOL) score
Time Frame
Up to 24 weeks
Title
Incidence of adverse events and adverse drug reactions
Description
Adverse events and adverse drug reactions
Time Frame
Up to 24 weeks
Title
Change rate from baseline in bone metabolic markers (BAP and serum NTx)
Description
Bone metabolic markers (BAP and serum NTx)
Time Frame
Up to 24 weeks
Title
Change rate from baseline in bone density (DXA)
Description
Bone density, T-score
Time Frame
Up to 24 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoshitaka Shimizu
Organizational Affiliation
Kissei Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Resarch Site
City
Multiple Locations
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia
We'll reach out to this number within 24 hrs