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A Randomized Study of Testosterone Replacement in Patients With Low Risk Hormone Refractory Prostate Cancer

NCT01187485 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-11-29

No results posted yet for this study

Summary

The purpose of this study is to see how safe Androderm® (the study drug) is at three different doses in subjects with early hormone refractory prostate cancer. In addition, information about hormonal levels and the effects of testosterone on quality of life including sexual functioning and muscle strength will be collected.

Conditions

Interventions

DRUG

Androderm® 2.5mg

Subjects will be asked to replace the study drug patch every 24 hours at night following the written and verbal instructions you will receive. The study drug patch should be placed over a small amount of a steroid cream on the skin to reduce irritation.

DRUG

Androderm® 5.0mg

Subjects will be asked to replace the study drug patch every 24 hours at night following the written and verbal instructions you will receive. The study drug patch should be placed over a small amount of a steroid cream on the skin to reduce irritation.

DRUG

Androderm® 7.5mg

Subjects will be asked to replace the study drug patch every 24 hours at night following the written and verbal instructions you will receive. The study drug patch should be placed over a small amount of a steroid cream on the skin to reduce irritation.

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Walter M Stadler, MD · University of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2008-02-29
Completion
2009-02-28

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 NCT01187485 on ClinicalTrials.gov