Prostate
Conditions
Keywords
Benign Prostate Hyperplasia
Brief summary
The primary objectives were to determine the efficacy and safety of the GITS formulation of Doxazosin in Taiwanese patients with prostate enlargement.
Interventions
DRUGDoxazosin mysylate GITS
Subjects initiated on 4 mg doxazosin GITS once daily at Visit 1 for four weeks. At Visit 2 (Week 4) increased to 8 mg Doxazosin GITS if efficacy response criteria not met.
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Taiwanese male subjects between 50 and 80 years of age who had: a primary diagnosis of BPH, defined as having an enlarged prostate (confirmed by digital rectal examination \[DRE\] and/or B-mode ultrasound); an IPSS score of ≥12; and a Qmax in the range of 5 to 15 mL/sec in a total voided volume of ≥150 mL, were eligible for the study.
Exclusion criteria
include but not limited to: * Previous prostate surgery, presence of a prostate stent or microwave thermotherapy and/or balloon dilatation within the previous 6 months * Concomitant therapy or previous therapy within 14 days with agents known to affect bladder or urethral function.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the maximum urinary flow rate (Qmax) from baseline | 8 weeks |
| Change in the International Prostate Symptom Score (IPSS) total score from baseline | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change in the International Prostate Symptom Score (IPSS) total score from baseline | 4 weeks |
| Change in the maximum urinary flow rate (Qmax) from baseline | 4 weeks |
| Change in the quality of life (QoL) assessment index score from baseline | 8 weeks |
Countries
Taiwan
Outcome results
None listed