Overview

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

Status:
Not yet recruiting
Trial end date:
2024-09-01
Target enrollment:
0
Participant gender:
Female
Summary
Multi-center, randomized, double-blind, parallel-group study to confirm superiority of KLH-2109 to placebo in uterine fibroids patient with menorrhagia and pain
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kissei Pharmaceutical Co., Ltd.
Criteria
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:

- Maximum diameter ≥3 cm

- No calcification

- Not receiving surgical treatment

- Patients diagnosed with menorrhagia with a total PBAC score ≥120 for one menstrual
cycle immediately before the start of the treatment period

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