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Efficacy Study for Use of Dutasteride (Avodart) With Testosterone Replacement

NCT00752869 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2013-02-26

No results posted yet for this study

Summary

This is a study using two FDA approved medications: Testosterone and the study medication, Dutasteride (Avodart 0.5mg/day). Half of the subjects will receive dutasteride and half will receive a placebo. The study medication will be taken for 12 months.

The subjects participating in the study are men who are already taking their own testosterone supplement because they have low testosterone levels which may cause them to experience sexual function difficulties, have fatigue or other symptoms. Testosterone can have an adverse effect of causing an enlarged prostate (Benign Prostatic Hypertrophy) (BPH).

Dutasteride (Avodart) is an approved medication used to decrease the prostate size, prevent urinary symptoms and reduce the risk of surgery.

The researchers would like to see if by taking dutasteride and testosterone at the same time they can prevent the adverse effects of testosterone and at the same time get the positive benefits of testosterone.

There will be 6 scheduled visits for the study and 2 diagnostic tests called a TRUS (TransRectal UltraSound), to evaluate prostate size. The six visits at will include consenting, blood work, two sexual function questionnaires, a physical examination, physical measurements, study medication teaching and dispensing of study medication.

Conditions

  • Hypogonadism

Interventions

DRUG

dutasteride

0.5mg by mouth one time per day for 1 year

DRUG

placebo

one tablet per day for 1 year

Sponsors & Collaborators

Principal Investigators

  • Martin M Miner, MD · The Miriam Hospital

  • Abraham Morgentaler, MD · Men's Health Boston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00752869 on ClinicalTrials.gov