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Purpose

The aim of this trial is to evaluate whether testosterone replacement results in greater improvement in pain perception, pain tolerance, sexual function, fatigue, and quality of life when compared with placebo in men with chronic spinal pain treated with opioids who have opioid-induced hypogonadism (low testosterone).

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Men, age 18 years and older. - Chronic non-cancer spinal pain. - Use of opioid analgesics for at least 6 months. - Serum total testosterone (measured by mass spectrometry) <348 ng/dL and/or free testosterone <70 pg/mL. - Ability and willingness to provide informed consent.

Exclusion Criteria

  • History of prostate cancer or breast cancer. - Known history of organic hypogonadism (e.g., due to hypothalamic, pituitary or testicular disease). - Use of testosterone within the past 6 months. - Baseline hematocrit >48%. - Prostate-specific antigen (PSA) level >4 ng/mL in Caucasians or >3 ng/mL in African-Americans. - Presence of prostate nodule or induration on digital rectal examination. - Uncontrolled congestive heart failure. - Myocardial infarction, acute coronary syndrome, revascularization surgery or stroke within 3 months. - Serum creatinine >2.5 mg/dL. - Alanine aminotransferase (ALT) level 3 times above the upper limit of normal. - Diagnosis of bipolar disorder or schizophrenia. - Presence of metallic implants (pacemakers, aneurysm clips, etc.) that preclude the patient from undergoing functional magnetic resonance imaging (MRI). In subjects who are otherwise eligible and either do not qualify for MRI or are reluctant to undergo imaging, the investigators may consider enrolling such participants on a case-by-case basis.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Testosterone 		Intramuscular injections of testosterone undecanoate 750 mg.
  • Drug: Testosterone Undecanoate 250 MG/ML
    Intramuscular administration at a dose of 750 mg at baseline, weeks 4, and week 14.
    Other names:
    • Testosterone
Placebo Comparator
Placebo 		Intramuscular injections of placebo.
  • Drug: Placebo
    Intramuscular administration of placebo at baseline, weeks 4, and week 14.
    Other names:
    • Control

Recruiting Locations

Brigham and Women's Hospital
Boston, Massachusetts 02115
Contact:
Leila Chammas
617-278-0722
lchammas@bwh.harvard.edu

More Details

Status
Recruiting
Sponsor
Brigham and Women's Hospital

Study Contact

Leila Chammas
617-278-0722
lchammas@bwh.harvard.edu

Detailed Description

This single-center, randomized, double-blind, placebo-controlled, parallel-group trial will evaluate pain and quality of life outcomes associated with 6 months of treatment with testosterone or placebo in men aged 18 years or older with chronic non-cancer spinal pain who are taking opioid analgesics for at least 6 months and have opioid-induced hypogonadism.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.