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

Kissei Pharmaceutical Co., Ltd.89 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Uterine Fibroids (MeSH Heading: Leiomyoma)

Interventions

KLH-2109DRUG

Oral administration

PlaceboDRUG

Oral administration

Eligibility

Sex: FEMALEMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Clinical Research Site

Multiple Locations, Japan

Outcomes

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

PBAC (pictorial blood loss assessment chart) score

Time frame: Up to 12 weeks

Proportion of women with a maximum NRS for pain score of 1 or less during 28 days before the end of study drug administration

NRS (numeric rating scale) for pain

Time frame: Up to 12 weeks

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

PBAC (pictorial blood loss assessment chart) score

Time frame: Up to 12 weeks

Proportion of subjects with a total PBAC score of less than 10 during 6 weeks before end of study drug administration

PBAC (pictorial blood loss assessment chart) score

Time frame: Up to 12 weeks

Proportion of subjects with a maximum NRS score of 1 or less for pain symptoms every 28 days

NRS (numerical rating scale)

Time frame: Up to 12 weeks

Proportion of subjects with maximum NRS score of zero for pain symptoms during 28 days before end of study drug administration

NRS (numerical rating scale)

Time frame: Up to 12 weeks

Proportion of subjects with a maximum NRS score of zero for pain symptoms every 28 days

NRS (numerical rating scale)

Time frame: Up to 12 weeks

Data from ClinicalTrials.gov

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