Completed

NCT Number: NCT05445167

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

Multi-center, randomized, double-blind, parallel-group study to confirm superiority of KLH-2109 to placebo in uterine fibroids patient with menorrhagia and pain

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Uterine Fibroids (MeSH Heading: Leiomyoma) Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Research Site

Multiple Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KLH-2109

Drug

Oral administration

Placebo

Drug

Oral administration

Primary outcomes

Proportion of subjects with a total PBAC score of less than 10 from Week 6 to 12 after beginning of study drug administration

Time frame: Up to 12 weeks

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

Time frame: Up to 12 weeks

NRS (numeric rating scale) for pain

Secondary outcomes

Proportion of subjects with a total PBAC score of less than 10 from Week 2 to 6 after beginning of study drug administration

Time frame: Up to 12 weeks

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

Time frame: Up to 12 weeks

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

Time frame: 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

Time frame: Up to 12 weeks

NRS (numerical rating scale)
Proportion of subjects with a maximum NRS score of zero for pain symptoms every 28 days

Time frame: Up to 12 weeks

NRS (numerical rating scale)
Average NRS score every 28 days for pain symptoms

Time frame: 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

Time frame: Up to 12 weeks

NRS (numerical rating scale)
Percentage of asymptomatic days (number of the days with NRS score of zero for pain symptoms) every 28 days

Time frame: Up to 12 weeks

NRS (numerical rating scale)
Incidence of adverse events and adverse drug reactions

Time frame: Up to 12 weeks

Adverse events and adverse drug reactions

Sponsors and collaborators

Lead sponsor

Kissei Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase III Confirmatory Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia and Pain

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Jul 6, 2022
Registry last updated: Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed