A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia and Pain
Primary Purpose
Uterine Fibroids (MeSH Heading: Leiomyoma)
Status
Active
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
KLH-2109
Placebo
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
- 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
Sites / Locations
- Clinical Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
KLH-2109
Placebo
Arm Description
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
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
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 during 6 weeks before end of study drug administration
PBAC (pictorial blood loss assessment chart) score
Proportion of subjects with a maximum NRS score of 1 or less for pain symptoms every 28 days
NRS (numerical rating scale)
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)
Proportion of subjects with a maximum NRS score of zero for pain symptoms every 28 days
NRS (numerical rating scale)
Average NRS score every 28 days for pain symptoms
NRS (numerical rating scale)
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)
Percentage of asymptomatic days (number of the days with NRS score of zero for pain symptoms) every 28 days
NRS (numerical rating scale)
Incidence of adverse events and adverse drug reactions
Adverse events and adverse drug reactions
Full Information
NCT ID
NCT05445167
First Posted
June 27, 2022
Last Updated
September 19, 2023
Sponsor
Kissei Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05445167
Brief Title
A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia and Pain
Official Title
A Phase III Confirmatory Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia and Pain
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
September 2024 (Anticipated)
Study Completion Date
September 2024 (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 superiority of KLH-2109 to placebo in uterine fibroids patient with menorrhagia and pain
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
78 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
KLH-2109
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
KLH-2109
Intervention Description
Oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral 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
Title
Proportion of women with a maximum NRS for pain score of 1 or less during 28 days before the end of study drug administration
Description
NRS (numeric rating scale) for pain
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 12 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 12 weeks
Title
Proportion of subjects with a maximum NRS score of 1 or less for pain symptoms every 28 days
Description
NRS (numerical rating scale)
Time Frame
Up to 12 weeks
Title
Proportion of subjects with maximum NRS score of zero for pain symptoms during 28 days before end of study drug administration
Description
NRS (numerical rating scale)
Time Frame
Up to 12 weeks
Title
Proportion of subjects with a maximum NRS score of zero for pain symptoms every 28 days
Description
NRS (numerical rating scale)
Time Frame
Up to 12 weeks
Title
Average NRS score every 28 days for pain symptoms
Description
NRS (numerical rating scale)
Time Frame
Up to 12 weeks
Title
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
Description
NRS (numerical rating scale)
Time Frame
Up to 12 weeks
Title
Percentage of asymptomatic days (number of the days with NRS score of zero for pain symptoms) every 28 days
Description
NRS (numerical rating scale)
Time Frame
Up to 12 weeks
Title
Incidence of adverse events and adverse drug reactions
Description
Adverse events and adverse drug reactions
Time Frame
Up to 12 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
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
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 Research 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 and Pain
We'll reach out to this number within 24 hrs