A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia (NCT05440383) | Clinical Trial Compass
CompletedPhase 3
A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia
Japan287 participantsStarted 2022-10-11
Plain-language 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
Who can participate
Age range20 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Proportion of subjects with a total PBAC score of less than 10 from Week 6 to 12 after beginning of study drug administration