Benign Prostatic Hyperplasia
Conditions
Brief summary
The purpose of this trial is to determine the efficacy and safety of an investigational drug in patients with benign prostatic hyperplasia.
Interventions
DRUGMK0906, finasteride / Duration of Treatment: 48 weeks
DRUGComparator: placebo / Duration of Treatment: 48 weeks
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
50 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Patients with benign prostatic hyperplasia
Exclusion criteria
* Patients who are suspected to be suffering from prostatic cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the International Prostate Symptom Score | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in QOL - index | — |
| Change from baseline in maximum urinary flow rate, % | — |
| Change from baseline in Prostate volume | — |
Outcome results
None listed