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

Phase 3

Completed

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

• Registration Number: NCT05445167
• Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-27
• Study First Submitted QC: 2022-06-30
• Study First Posted: 2022-07-06
• Study Start: 2022-10-11
• Primary Completion: 2024-02-16
• Study Completion: 2024-02-16
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 89

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
KLH-2109	KLH-2109	-

Primary Outcome Measures

Name	Time	Method
Proportion of women with a maximum NRS for pain score of 1 or less during 28 days before the end of study drug administration	Up to 12 weeks	NRS (numeric rating scale) for pain
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
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 12 weeks	PBAC (pictorial blood loss assessment chart) score
Average NRS score every 28 days for pain symptoms	Up to 12 weeks	NRS (numerical rating scale)
Proportion of subjects with a maximum NRS score of 1 or less for pain symptoms every 28 days	Up to 12 weeks	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	Up to 12 weeks	NRS (numerical rating scale)
Proportion of subjects with a total PBAC score of less than 10 during 6 weeks before end of study drug administration	Up to 12 weeks	PBAC (pictorial blood loss assessment chart) score
Percentage of asymptomatic days (number of the days with NRS score of zero for pain symptoms) every 28 days	Up to 12 weeks	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	Up to 12 weeks	NRS (numerical rating scale)
Proportion of subjects with a maximum NRS score of zero for pain symptoms every 28 days	Up to 12 weeks	NRS (numerical rating scale)
Incidence of adverse events and adverse drug reactions	Up to 12 weeks	Adverse events and adverse drug reactions

Trial Locations

Locations (1)

Clinical Research Site; 🇯🇵 Multiple Locations, Japan