NCT00127179

Brief Summary

The purpose of this trial is to determine the efficacy and safety of an investigational drug in patients with benign prostatic hyperplasia.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2004

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2005

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2005

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

1.5 years

First QC Date

August 3, 2005

Last Update Submit

August 13, 2024

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in the International Prostate Symptom Score

Secondary Outcomes (3)

  • Change from baseline in QOL - index

  • Change from baseline in maximum urinary flow rate, %

  • Change from baseline in Prostate volume

Interventions

MK0906, finasteride / Duration of Treatment: 48 weeksDRUG
Comparator: placebo / Duration of Treatment: 48 weeksDRUG

Eligibility Criteria

Age50 Years - 79 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with benign prostatic hyperplasia

You may not qualify if:

  • Patients who are suspected to be suffering from prostatic cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

FinasterideDuration of Therapy

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

AndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsAzasteroidsSteroids, HeterocyclicPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2005

First Posted

August 5, 2005

Study Start

January 1, 2004

Primary Completion

July 1, 2005

Study Completion

July 25, 2005

Last Updated

August 15, 2024

Record last verified: 2022-02