Testosterone Replacement for Fatigue in Male Hypogonadic Advanced Cancer Patients

NCT00965341 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2016-09-13

Study results available
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Summary

The goal of this clinical research study is to learn if and how testosterone replacement therapy may affect fatigue in males with advanced cancer and low testosterone levels.

Conditions

Interventions

DRUG

Testosterone

Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.

DRUG

Placebo

Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Rony Dev, DO · UT MD Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States

Study Locations

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Entities

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 NCT00965341 on ClinicalTrials.gov