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

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Kissei

Status and phase

Active, not recruiting
Phase 3

Conditions

Uterine Fibroids (MeSH Heading: Leiomyoma)

Treatments

Drug: KLH-2109
Drug: Leuprorelin

Study type

Interventional

Funder types

Industry

Identifiers

NCT05440383
KLH2301

Details and patient eligibility

About

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

Enrollment

264 estimated patients

Sex

Female

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

264 participants in 2 patient groups

KLH-2109
Experimental group
Description:
Oral administration
Treatment:
Drug: KLH-2109
Leuprorelin
Active Comparator group
Description:
Subcutaneous administration
Treatment:
Drug: Leuprorelin

Trial contacts and locations

1

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Central trial contact

Kissei Pharmaceutical Co., Ltd.

Data sourced from clinicaltrials.gov

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