Benign prostatic hyperplasia
Conditions
Interventions
investigational material(s)
Generic name etc : AKP-009 (Study code)
INN of investigational material : -
Therapeutic category code : 249 Other hormone preparations (including antihormone preparations)
Sponsors
ASKA Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Subjects who are able to understand the details of the study and obtain written consent to participate in the study at his own discretion. 2) Japanese men aged 50 years or older at the time of obtaining informed consent. 3) Subjects diagnosed with BPH. 4) Subjects with a prostate volume of 30 mL or more as measured by transrectal ultrasonography. 5) Subjects with an International Prostate Symptom Score (IPSS) of 8 points or higher. 6) Subjects with a quality of life (QOL) score of 2 or higher. 7) Subjects who have a maximum urinary flow rate (Qmax) of less than 15 mL/sec (The voided volume have to be 150ml or more).
Exclusion criteria
Exclusion criteria: Subjects who have a post void residual urine volume of 250 mL or more as measured by transabdominal ultrasonography. Subjects with a prostate-specific antigen (PSA) level higher than 10.0 ng/mL. Subjects with or strongly suspected of having disease affecting lower urinary tract function other than benign prostatic hyperplasia. Subjects with a history of treatment that may affect lower urinary tract function (e.g., surgery to the lower urinary tract or prostate, indwelling bladder catheterization). Subjects with prostate cancer or other malignancies or those with a history of such malignancies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy Percentage change from baseline in prostate volume at Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Change from baseline in IPSS Change from baseline in QOL Score Change from baseline in Qmax Change from baseline in post void residual urine volume | — |
Countries
Japan
Outcome results
None listed