A clinical study of KLH-2109 in uterine fibroids patient with menorrhagia
- Conditions
- Uterine fibroid
- Registration Number
- jRCT2031220180
- Lead Sponsor
- Kissei Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- 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
- parallel assignment
- Primary Outcome Measures
Name Time Method Proportion of subjects with a total PBAC score of less than 10 Week 6 to 12 after beginning of study drug administration Proportion of subjects with a total Pictorial Blood Assessment Chart (PBAC) score of less than 10
- Secondary Outcome Measures
Name Time Method Changes and fluctuations from baseline in laboratory tests Changes and fluctuations from baseline in laboratory tests (hematological, biochemical and urinalysis)
Changes and fluctuations from baseline in vital signs Changes and fluctuations from baseline in vital signs (blood pressure, pulse rate and body temperature)
Proportion of subjects with a total PBAC score of less than 10 6 weeks before end of study drug administration Proportion of subjects with a total PBAC score of less than 10
Change from baseline in blood hemoglobin Change from baseline in blood hemoglobin
Change rate from baseline in myoma volume Change rate from baseline in myoma volume
Change rate from baseline in uterine volume Change rate from baseline in uterine volume
Change from baseline in UFS-QOL score Change from baseline in UFS-QOL score
Incidence of adverse events and adverse drug reactions Incidence of adverse events and adverse drug reactions
Changes and fluctuations from baseline in body weight Changes and fluctuations from baseline in body weight
Changes and fluctuations from baseline in parameters of 12-lead ECG Changes and fluctuations from baseline in parameters of 12-lead ECG
Change rate from baseline in bone metabolic markers Change rate from baseline in bone metabolic markers (BAP and serum NTx)
Change rate from baseline in bone density Change rate from baseline in bone density (DXA)