NCT00398034

Brief Summary

The purpose of this pilot study is to test the effects of testosterone replacement on pain, fatigue, mood, cognition and libido in hypogonadal men on long-term opioid therapy for chronic pain.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2006

Status
withdrawn

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

October 30, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 10, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2007

Completed
Last Updated

October 13, 2023

Status Verified

November 1, 2006

Enrollment Period

10 months

First QC Date

November 8, 2006

Last Update Submit

October 11, 2023

Conditions

PainHypogonadism

Keywords

opioidspainhypogonadismdepressionfatiguecognitionlibido

Outcome Measures

Primary Outcomes (1)

  • • To determine if testosterone replacement can improve pain control in opioid-treated, hypogonadal men with chronic pain.

Secondary Outcomes (7)

  • In opioid-treated, hypogonadal men with chronic pain, to determine whether testosterone replacement therapy (TRT) will:

  • reduce the opioid requirement.

  • improve fatigue

  • improve depression

  • improve sexual function.

  • +2 more secondary outcomes

Interventions

Testosterone GelDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult male patients (above 18 years old and below 60 years old)
  • Receiving greater than 20 IV morphine equivalents/day with \<20% change in dosage in the last month.
  • AM total testosterone \<300 ng/dL
  • Report "worst pain during the past week" grater than 4 on an 11-point numeric scale.

You may not qualify if:

  • Females
  • Poorly controlled, symptomatic, active medical or psychiatric problems (e.g., HIV, hepatitis, diabetes, cancer, benign prostatic hypertrophy, substance abuse, major depression)
  • Neurological or psychiatric disorder that would compromise the patient's ability to give informed consent or adhere to the requirements of the protocol.
  • History of prostate cancer, abnormal findings on digital rectal exam, or PSA greater than 4.0 ng/m
  • History of polycythemia
  • Renal or hepatic dysfunction
  • Hematocrit \>55%
  • Known history of hypersensitivity to transdermal testosterone gel.
  • Abnormalities during digital rectal exam.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (70)

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MeSH Terms

Conditions

PainHypogonadismDepressionFatigue

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsGonadal DisordersEndocrine System DiseasesBehavioral SymptomsBehavior

Study Officials

  • Christopher P Cardozo, M.D.

    James J. Peters VAMC

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

November 8, 2006

First Posted

November 10, 2006

Study Start

October 30, 2006

Primary Completion

September 6, 2007

Study Completion

September 6, 2007

Last Updated

October 13, 2023

Record last verified: 2006-11