A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia and Pain
Study Details
Study Description
Brief Summary
Multi-center, randomized, double-blind, parallel-group study to confirm superiority of KLH-2109 to placebo in uterine fibroids patient with menorrhagia and pain
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: KLH-2109
|
Drug: KLH-2109
Oral administration
|
| Placebo Comparator: Placebo
|
Drug: Placebo
Oral administration
|
Outcome Measures
Primary Outcome Measures
- Proportion of subjects with a total PBAC score of less than 10 from Week 6 to 12 after beginning of study drug administration [Up to 12 weeks]
PBAC (pictorial blood loss assessment chart) score
- Proportion of women with a maximum NRS for pain score of 1 or less during 28 days before the end of study drug administration [Up to 12 weeks]
NRS (numeric rating scale) for pain
Secondary Outcome Measures
- Proportion of subjects with a total PBAC score of less than 10 from Week 2 to 6 after beginning of study drug administration [Up to 12 weeks]
PBAC (pictorial blood loss assessment chart) score
- Proportion of subjects with a total PBAC score of less than 10 during 6 weeks before end of study drug administration [Up to 12 weeks]
PBAC (pictorial blood loss assessment chart) score
- Proportion of subjects with a maximum NRS score of 1 or less for pain symptoms every 28 days [Up to 12 weeks]
NRS (numerical rating scale)
- Proportion of subjects with maximum NRS score of zero for pain symptoms during 28 days before end of study drug administration [Up to 12 weeks]
NRS (numerical rating scale)
- Proportion of subjects with a maximum NRS score of zero for pain symptoms every 28 days [Up to 12 weeks]
NRS (numerical rating scale)
- Average NRS score every 28 days for pain symptoms [Up to 12 weeks]
NRS (numerical rating scale)
- 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 [Up to 12 weeks]
NRS (numerical rating scale)
- Percentage of asymptomatic days (number of the days with NRS score of zero for pain symptoms) every 28 days [Up to 12 weeks]
NRS (numerical rating scale)
- Incidence of adverse events and adverse drug reactions [Up to 12 weeks]
Adverse events and adverse drug reactions
Eligibility Criteria
Criteria
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
-
Patients with pain symptoms associated with uterine fibroids
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Kissei Pharmaceutical Co., Ltd.
Investigators
- Study Director: Yoshitaka Shimizu, Kissei Pharmaceutical Co., Ltd.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KLH2302