JRCT ID: jRCT2031220180
Registered date:03/07/2022
A clinical study of KLH-2109 in uterine fibroids patient with menorrhagia
Basic Information
Recruitment status | Not Recruiting |
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Health condition(s) or Problem(s) studied | Uterine fibroid |
Date of first enrollment | 23/06/2022 |
Target sample size | 264 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Oral administration of KLH-2109 or subcutaneous administration of leuprorelin acetate |
Outcome(s)
Primary Outcome | Proportion of subjects with a total PBAC score of less than 10 from Week 6 to 12 after beginning of study drug administration |
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Secondary Outcome | - Proportion of subjects with a total PBAC score of less than 10 from Week 2 to 6 after beginning of study drug administration - Proportion of subjects with a total PBAC score of less than 10 from Week 18 to 24 after beginning of study drug administration - Proportion of subjects with a total PBAC score of less than 10 during 6 weeks before end of study drug administration - Change from baseline in blood hemoglobin - Change rate from baseline in myoma volume - Change rate from baseline in uterine volume - Change from baseline in UFS-QOL score - Incidence of adverse events and adverse drug reactions - Changes and fluctuations from baseline in laboratory tests (hematological, biochemical and urinalysis) - Changes and fluctuations from baseline in vital signs (blood pressure, pulse rate and body temperature) - Changes and fluctuations from baseline in body weight - Changes and fluctuations from baseline in parameters of 12-lead ECG - Change rate from baseline in bone metabolic markers (BAP and serum NTx) - Change rate from baseline in bone density (DXA) |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Female |
Include criteria | - 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 |
Exclude 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 |
Related Information
Primary Sponsor | Shimizu Yoshitaka |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | NCT05440383 |
Contact
Public contact | |
Name | Yoshitaka Shimizu |
Address | 3-1-3, Koishikawa, Bunkyo-Ku, Tokyo, 112 0002, Japan Tokyo Japan 112-0002 |
Telephone | +81-120-007-622 |
rinsyousiken@pharm.kissei.co.jp | |
Affiliation | Kissei Pharmaceutical Co., Ltd. |
Scientific contact | |
Name | Yoshitaka Shimizu |
Address | 3-1-3, Koishikawa, Bunkyo-Ku, Tokyo, 112 0002, Japan Tokyo Japan 112-0002 |
Telephone | +81-120-007-622 |
rinsyousiken@pharm.kissei.co.jp | |
Affiliation | Kissei Pharmaceutical Co., Ltd. |