Uterine Fibroids (MeSH Heading: Leiomyoma)
Conditions
Brief summary
Multi-center, randomized, double-blind, parallel-group study to confirm non-inferiority of KLH-2109 to Leuprorelin acetate in uterine fibroids patient with menorrhagia
Interventions
DRUGKLH-2109
Oral administration
DRUGLeuprorelin
Subcutaneous 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
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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with a total PBAC score of less than 10 from Week 18 to 24 after beginning of study drug administration | Up to 24 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 24 weeks | PBAC (pictorial blood loss assessment chart) score |
| Change from baseline in blood hemoglobin | Up to 24 weeks | Hemoglobin |
| Change rate from baseline in myoma volume | Up to 24 weeks | Myoma volume |
| 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 24 weeks | PBAC (pictorial blood loss assessment chart) score |
| Change from baseline in UFS-QOL score | Up to 24 weeks | UFS-QOL (uterine fibroid symptom and QOL) score |
| Incidence of adverse events and adverse drug reactions | Up to 24 weeks | Adverse events and adverse drug reactions |
| Change rate from baseline in bone metabolic markers (BAP and serum NTx) | Up to 24 weeks | Bone metabolic markers (BAP and serum NTx) |
| Change rate from baseline in bone density (DXA) | Up to 24 weeks | Bone density, T-score |
| Change rate from baseline in uterine volume | Up to 24 weeks | Uterine volume |
Countries
Japan
Outcome results
None listed