Completed

NCT Number: NCT05440383

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

Multi-center, randomized, double-blind, parallel-group study to confirm non-inferiority of KLH-2109 to Leuprorelin acetate in uterine fibroids patient with menorrhagia

Completed

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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 Resarch 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

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

leuprorelin

Drug

Subcutaneous 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

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 24 weeks

PBAC (pictorial blood loss assessment chart) score
Proportion of subjects with a total PBAC score of less than 10 from Week 18 to 24 after beginning of study drug administration

Time frame: Up to 24 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 24 weeks

PBAC (pictorial blood loss assessment chart) score
Change from baseline in blood hemoglobin

Time frame: Up to 24 weeks

Hemoglobin
Change rate from baseline in myoma volume

Time frame: Up to 24 weeks

Myoma volume
Change rate from baseline in uterine volume

Time frame: Up to 24 weeks

Uterine volume
Change from baseline in UFS-QOL score

Time frame: Up to 24 weeks

UFS-QOL (uterine fibroid symptom and QOL) score
Incidence of adverse events and adverse drug reactions

Time frame: Up to 24 weeks

Adverse events and adverse drug reactions
Change rate from baseline in bone metabolic markers (BAP and serum NTx)

Time frame: Up to 24 weeks

Bone metabolic markers (BAP and serum NTx)
Change rate from baseline in bone density (DXA)

Time frame: Up to 24 weeks

Bone density, T-score

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

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Jun 30, 2022
Registry last updated: Mar 14, 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