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A phase III confirmatory study of KLH-2109 in uterine fibroids patient with menorrhagia and pain

A clinical study of KLH-2109 in uterine fibroids patient with menorrhagia and pain

Shimizu Yoshitaka

Kissei Pharmaceutical Co., Ltd.

3-1-3, Koishikawa, Bunkyo-Ku, Tokyo, 112 0002, Japan

rinsyousiken@pharm.kissei.co.jp

Shimizu Yoshitaka

Kissei Pharmaceutical Co., Ltd.

3-1-3, Koishikawa, Bunkyo-Ku, Tokyo, 112 0002, Japan

+81-120-007-622

rinsyousiken@pharm.kissei.co.jp

Complete

June. 23, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- 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 pain symptoms associated with uterine fibroids

- 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

Female

Uterine fibroid

Oral administration of KLH-2109 or placebo

- Proportion of subjects with a total PBAC score of less than 10 from Week 6 to 12 after beginning of study drug administration
- Proportion of subjects with a maximum NRS for pain score of 1 or less during 28 days before the end of study drug administration

- 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 during 6 weeks before end of study drug administration
- Proportion of subjects with a maximum NRS score of 1 or less for pain symptoms every 28 days
- Proportion of subjects with maximum NRS score of zero for pain symptoms during 28 days before end of study drug administration
- Proportion of subjects with a maximum NRS score of zero for pain symptoms every 28 days
- Average NRS score every 28 days for pain symptoms
- Percentage of asymptomatic days (number of the days with NRS score of zero for pain symptoms) during 28 days before end of study drug administration
- Percentage of asymptomatic days (number of the days with NRS score of zero for pain symptoms) every 28 days
- 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

+81-3-6779-8166

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