Clinical trial NCT05445167: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Uterine Fibroids (MeSH Heading: Leiomyoma)
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-07-06
Enrollment: 89
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Proportion of subjects with a total PBAC score of less than 10 from Week 6 to 12 after beginning of study drug administration
timeFrame: Up to 12 weeks
measure: Proportion of women with a maximum NRS for pain score of 1 or less during 28 days before the end of study drug administration
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Proportion of subjects with a total PBAC score of less than 10 from Week 2 to 6 after beginning of study drug administration
timeFrame: Up to 12 weeks
measure: Proportion of subjects with a total PBAC score of less than 10 during 6 weeks before end of study drug administration
timeFrame: Up to 12 weeks
measure: Proportion of subjects with a maximum NRS score of 1 or less for pain symptoms every 28 days
timeFrame: Up to 12 weeks
measure: Proportion of subjects with maximum NRS score of zero for pain symptoms during 28 days before end of study drug administration
timeFrame: Up to 12 weeks
measure: Proportion of subjects with a maximum NRS score of zero for pain symptoms every 28 days
timeFrame: Up to 12 weeks
measure: Average NRS score every 28 days for pain symptoms
timeFrame: Up to 12 weeks
measure: 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
timeFrame: Up to 12 weeks
measure: Percentage of asymptomatic days (number of the days with NRS score of zero for pain symptoms) every 28 days
timeFrame: Up to 12 weeks
measure: Incidence of adverse events and adverse drug reactions
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
facility: Clinical Research Site
Study officials:
affiliation: Kissei Pharmaceutical Co., Ltd.
name: Yoshitaka Shimizu
role: STUDY_DIRECTOR
References: