## Protocol Section
### Identification Module
**NCT ID:** NCT00127179

**Brief Title:** A Study of an Investigational Study Drug for Benign Prostatic Hyperplasia (0906-140)

**Official Title:** MK0906 Phase III Double-Blind Comparative Study - Benign Prostate Hyperplasia

#### Organization Study ID Info
**ID:** 0906-140
#### Organization
**Class:** INDUSTRY
**Full Name:** Organon and Co
#### Secondary ID Infos
**ID:** MK0906-140
**ID:** 2005_042
### Status Module
#### Completion Date
**Date:** 2005-07-25

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-02-16

**Type:** ACTUAL

**Last Update Submit Date:** 2022-02-04

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2005-07-01

**Type:** ACTUAL

#### Start Date
**Date:** 2004-01-01

**Type:** ACTUAL

**Status Verified Date:** 2022-02

#### Study First Post Date
**Date:** 2005-08-05
**Type:** ESTIMATED
**Study First Submit Date:** 2005-08-03
**Study First Submit QC Date:** 2005-08-04
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Organon and Co

#### Responsible Party

**Type:** SPONSOR

### Description Module

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

### Conditions Module

**Conditions:**

- Benign Prostatic Hyperplasia

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 600

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** MK0906, finasteride / Duration of Treatment: 48 weeks

**Type:** DRUG

#### Intervention 2

**Name:** Comparator: placebo / Duration of Treatment: 48 weeks

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Change from baseline in the International Prostate Symptom Score

#### Secondary Outcomes

**Measure:** Change from baseline in QOL - index

**Measure:** Change from baseline in maximum urinary flow rate, %

**Measure:** Change from baseline in Prostate volume

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients with benign prostatic hyperplasia

Exclusion Criteria:

* Patients who are suspected to be suffering from prostatic cancer

**Maximum Age:** 79 Years

**Minimum Age:** 50 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Merck Sharp & Dohme LLC

**Name:** Medical Monitor

**Role:** STUDY_DIRECTOR

### References Module

#### Available IPDs

**Type:** CSR Synopsis

**URL:** http://www.merck.com/clinical-trials/policies-perspectives.html

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000011469

- Term: Prostatic Diseases

- ID: D000005832

- Term: Genital Diseases, Male

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M14334

- Name: Prostatic Hyperplasia

- Relevance: HIGH

- As Found: Prostatic Hyperplasia

- ID: M10016

- Name: Hyperplasia

- Relevance: HIGH

- As Found: Hyperplasia

- ID: M14333

- Name: Prostatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8944

- Name: Genital Diseases, Male

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011470

- Term: Prostatic Hyperplasia

- ID: D000006965

- Term: Hyperplasia

### Intervention Browse Module - Ancestors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000058891

- Term: 5-alpha Reductase Inhibitors

- ID: D000065088

- Term: Steroid Synthesis Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000006727

- Term: Hormone Antagonists

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000064804

- Term: Urological Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Urol

- Name: Urological Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M20273

- Name: Finasteride

- Relevance: HIGH

- As Found: Gemcitabine 1000 mg

- ID: M29274

- Name: 5-alpha Reductase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000018120

- Term: Finasteride

### Misc Info Module

#### Removed Countries

- Country: Japan

- Version Holder: 2024-05-24
