A clinical study of KLH-2109 in uterine fibroids patient with menorrhagia
- Conditions
- terine fibroid
- Registration Number
- JPRN-jRCT2031220180
- Lead Sponsor
- Shimizu Yoshitaka
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 264
Japanese uterine fibroid patients
- Premenopausal female patient over 20 years old
- 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 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of subjects with a total PBAC score of less than 10 from Week 6 to 12 after beginning of study drug administration
- Secondary Outcome Measures
Name Time Method