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

Last updated: March 12, 2025
Sponsor: Kissei Pharmaceutical Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Heavy Bleeding / Heavy Periods

Female Hormonal Deficiencies/abnormalities

Uterine Fibroids

Treatment

KLH-2109

Leuprorelin

Clinical Study ID

NCT05440383
KLH2301
  • Ages > 20
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Premenopausal Japanese woman diagnosed with uterine fibroids

  • Patients confirmed by transvaginal ultrasonography to have at least 1 myoma thatmeet 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

Exclusion Criteria:

  • Patients with complication or history of blood system diseases (salasemia, sickleerythrocyte anemia, folic acid deficiency, coagulation disorder, etc.) (excludingiron deficiency anemia and latent iron deficiency anemia)

  • Patients with lower abdominal pain due to irritable bowel syndrome or lowerabdominal pain due to severe interstitial cystitis

  • Patients with undiagnosed abnormal genital bleeding

Study Design

Total Participants: 287
Treatment Group(s): 2
Primary Treatment: KLH-2109
Phase: 3
Study Start date:
October 11, 2022
Estimated Completion Date:
August 21, 2024

Connect with a study center

  • Clinical Resarch Site

    Multiple Locations,
    Japan

    Site Not Available

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