MedTrace Logo

Testosterone for Penile Rehabilitation After Radical Prostatectomy

NCT00848497 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2015-06-19

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to determine the effectiveness of testosterone replacement therapy (TRT) in men following surgery to remove the prostate in improving erectile function. Subjects will be randomized (like flipping a coin) to one of two groups. One group will receive Testim® (testosterone gel) 5 g per day plus Viagra 25 mg every night and the other will receive Placebo-Testim® 5 g per day plus Viagra 25 mg every night.

Subjects will begin drug treatment 3 months after the initial screening visit and will take study drug for 3 months only. Participation will end at the end of the 6-month visit.

Conditions

Interventions

DRUG

Testim®

Testim® 5 g of gel (one tube) containing 50 mg of testosterone once daily. This was the dose given to the patient which he started.

OTHER

Placebo Testim®

Placebo Testim® 5 g of gel (one tube)

DRUG

Viagra®

Viagra 25mg was the dose given to the patient which he started.

Sponsors & Collaborators

  • Mohit Khera

    lead OTHER

Principal Investigators

  • Mohit Khera, MD · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00848497 on ClinicalTrials.gov