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A Study of an Investigational Study Drug for Benign Prostatic Hyperplasia (0906-140)

MK0906 Phase III Double-Blind Comparative Study - Benign Prostate Hyperplasia

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00127179
Enrollment
600
Registered
2005-08-05
Start date
2004-01-01
Completion date
2005-07-25
Last updated
2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia

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
Lead SponsorINDUSTRY

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

MeasureTime frame
Change from baseline in the International Prostate Symptom Score

Secondary

MeasureTime 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

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026