Effect Of Dutasteride On Intraprostatic Dihydrotestostero... | NCT00062790

Studies
Effect Of Dutasteride On Intraprostatic Dihydrotestosterone (DHT) Levels

NCT00062790

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Sep 15, 2016Estimated

Enrollment

Phase

Phase 4

Conditions

Prostatic Hyperplasia

Interventions

Dutasteride

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2003

Primary Completion Date

Not provided

Completion Date

Jul 2005Actual

First Submitted Date

Jun 16, 2003

First Submission Date that Met QC Criteria

Jun 16, 2003

First Posted Date

Jun 17, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2016

Last Update Posted Date

Sep 15, 2016Estimated

Description Module

Brief Summary

This study is being done to determine how much certain hormone levels in the prostate decrease when a patient takes dutasteride 0.5mg daily for 3 months prior to TURP. Male patients at least 50 years old willing to take either dutasteride or a placebo (dummy pill) once daily by mouth for 3 months prior to having a surgery to reduce the size of their prostate. During the surgery, very small pieces of the prostate that are removed will be tested to see how much dihydrotestosterone and testosterone (male hormones) are in the tissue.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Dutasteride	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effect of repeat oral daily dosing of 0.5mg dutasteride compared to placebo on prostate tissue content of DHT in patients treated for 3 months prior to transurethral resection of the prostate (TURP).

Secondary Outcomes

Measure	Description	Time Frame
Effect of repeat oral once daily dosing of 0.5mg dutasteride compared to placebo on prostatic tissue content of testosterone.
Changes in serum DHT (dihydrotestosterone) and T (testosterone).

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Diagnosed with benign prostatic hyperplasia
Must be scheduled to have a transurethral resection of the prostate (prostate surgery) and be able to wait 3 months to have the procedure.
PSA (prostate specific antigen) level must be between 1.5 and 15 ng/ml.

Exclusion criteria:

Prostate cancer.
Use of saw palmetto or other over the counter treatments for prostate health chemically related to the study medication.
Previous finasteride use or other investigational 5ARI within 6 months prior to screening.
History of chronic UTIs (urinary tract infections)
Presence of acute bacterial prostatitis at screening

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Long Beach	California	90806	United States
GSK Investigational Site

References Module

Citations

Not provided

ID	Term
D011469	Prostatic Diseases
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases

ID	Term
D001378	Azasteroids
D013260	Steroids, Heterocyclic
D013256	Steroids
D000072473	Fused-Ring Compounds