NCT00382356

Brief Summary

The study is to determine the safety and efficacy of Dutasteride in patients who have failed Finasteride therapy for their symptomatic benign prostatic enlargement/ hypertrophy (BPE/H).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2004

Longer than P75 for not_applicable

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

November 1, 2004

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

October 19, 2012

Status Verified

October 1, 2012

Enrollment Period

4.7 years

First QC Date

September 28, 2006

Last Update Submit

October 18, 2012

Conditions

Benign Prostatic Hypertrophy

Keywords

Benign Prostatic EnlargementBenign Prostatic HypertrophyDutasteride5-alpha reductase inhibitorsHormonal therapy

Outcome Measures

Primary Outcomes (1)

  • Urodynamic parameters (Qmax, Voided volume, and PVR) and AUASS

    12 months

Secondary Outcomes (1)

  • To assess safety and tolerability of Dutasteride

    12 months

Study Arms (1)

study drug

EXPERIMENTAL

Open label, single arm

Drug: Dutasteride

Interventions

DutasterideDRUG

once daily dosing of 0.5mg Dutasteride for 12 months

Also known as: Avodart
study drug

Eligibility Criteria

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

You may qualify if:

  • Male with history of treatment with Finasteride for more than six months, and who demonstrate clinical evidence of failure (subjective symptoms of bladder outlet obstruction secondary to BPH-related LUTS; objective evidence: AUASS\> 10;Q-max \> 5cc/sec and \<10c/sec (total voided volume of at least 125cc); post void volumes \> 200cc)
  • Prostate volume \> 30cc and \< 80cc by transrectal ultrasound measurement
  • Total Serum PSA of \< 15 ng/ml (corrected for Finasteride therapy)
  • Willingness and ability to give written informed consent and comply with study instructions and procedures.

You may not qualify if:

  • Clinical evidence of non-response to therapy with Finasteride for symptomatic BPH.
  • Total serum corrected PSA of greater than 15 ng/ml
  • History or clinical evidence of prostate cancer
  • History of acute urinary retention in three months prior.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Dutasteride

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

AzasteroidsSteroids, HeterocyclicSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Unyime O Nseyo, M.D.

    NF/SGVAHS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHYSICIAN

Study Record Dates

First Submitted

September 28, 2006

First Posted

September 29, 2006

Study Start

November 1, 2004

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

October 19, 2012

Record last verified: 2012-10