A clinical study of KLH-2109 in uterine fibroids patient with menorrhagia and pain

Completed

• Conditions: Uterine fibroid

• Registration Number: jRCT2031220181
• Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-05
• Last Update Posted: 2025-03-18

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 78

Inclusion Criteria

• Japanese uterine fibroid patients
• Premenopausal female patient over 20 years old
• 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

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
Proportion of subjects with a maximum NRS for pain score of 1 or less	28 days before the end of study drug administration	Proportion of subjects with a maximum NRS for pain score of 1 or less during 28 days before the end of study drug administration
Proportion of subjects with a total PBAC score of less than 10	Week 6 to 12 after beginning of study drug administration	Proportion of subjects with a total PBAC score of less than 10 from Week 6 to 12 after beginning of study drug administration

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with a total PBAC score of less than 10 from Week 2 to 6	Week 2 to 6 after beginning of study drug administration	Proportion of subjects with a total PBAC score of less than 10 from Week 2 to 6 after beginning of study drug administration
Proportion of subjects with a total PBAC score of less than 10 during 6 weeks before end	6 weeks before end of study drug administration	Proportion of subjects with a total PBAC score of less than 10 during 6 weeks before end of study drug administration
Proportion of subjects with a maximum NRS score of 1 or less for pain symptoms every 28 days	every 28 days	Proportion of subjects with a maximum NRS score of 1 or less for pain symptoms every 28 days
Proportion of subjects with maximum NRS score of zero for pain symptoms during 28 days before end	28 days before end of study drug administration	Proportion of subjects with maximum NRS score of zero for pain symptoms during 28 days before end of study drug administration
Proportion of subjects with a maximum NRS score of zero for pain symptoms every 28 days	every 28 days	Proportion of subjects with a maximum NRS score of zero for pain symptoms every 28 days
Average NRS score every 28 days for pain symptoms	every 28 days	Average NRS score every 28 days for pain symptoms
Percentage of asymptomatic days during 28 days before end	28 days before end of study drug administration	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
Percentage of asymptomatic days every 28 days	every 28 days	Percentage of asymptomatic days (number of the days with NRS score of zero for pain symptoms) every 28 days
Incidence of adverse events and adverse drug reactions		Incidence of adverse events and adverse drug reactions
Changes and fluctuations from baseline in laboratory tests		Changes and fluctuations from baseline in laboratory tests (hematological, biochemical and urinalysis)
Changes and fluctuations from baseline in vital signs		Changes and fluctuations from baseline in vital signs (blood pressure, pulse rate and body temperature)
Changes and fluctuations from baseline in body weight		Changes and fluctuations from baseline in body weight
Changes and fluctuations from baseline in parameters of 12-lead ECG		Changes and fluctuations from baseline in parameters of 12-lead ECG