Status:
COMPLETED
Effects of Testosterone Replacement on Pain Sensitivity and Pain Perception
Lead Sponsor:
Boston University
Conditions:
Pain
Hypogonadism
Eligibility:
MALE
18-100 years
Phase:
PHASE2
Brief Summary
Naturally occurring opiates (endorphins) decrease testosterone levels by inhibiting the synthesis of gonadotropin releasing hormone (GnRH) and also inhibiting testosterone synthesis by the testes. Sim...
Eligibility Criteria
Inclusion
- Men
- Age 18 years and older
- Non-cancer chronic pain
- Serum total testosterone level \<350 ng/dl
- Consumption of at least 20 mg of hydrocodone (or analgesic equivalent of another opioid) for at least 4 weeks
- Absence of hospitalization in the past 2 months
- No acute illness in the past 2 months
- No current anabolic therapy (growth hormone, DHEA, etc)
- No current use or consumption in the past 2 months of melatonin
- Normal prostate exam
- Normal PSA level
Exclusion
- Cancer-related chronic pain
- Liver enzymes \> 3 times upper limit of normal
- Serum creatinine \> 2 times upper limit of normal
- Neurological disease
- Active psychiatric illness
- Any addictive drug use
- Alcoholism (\>3 drinks/day)
- Patients currently receiving melatonin or anabolic agents
- Hospitalization in the past 2 months
- Acute illness in the past 2 months
- Consumption of \< 20 mg of hydrocodone (or analgesic equivalent of another opioid)
- Severe BPH
- PSA \> 4.0 ng/ml
- Prostate cancer
- Breast cancer
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00351819
Start Date
April 1 2006
End Date
November 1 2012
Last Update
June 28 2017
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115