Uterine Fibroids (MeSH Heading: Leiomyoma)
Conditions
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
Interventions
DRUGKLH-2109
Oral administration
DRUGPlacebo
Oral administration
Sponsors
Kissei Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
| 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 |
| Average NRS score every 28 days for pain symptoms | Up to 12 weeks | NRS (numerical rating scale) |
| 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 |
Countries
Japan
Outcome results
None listed