Pain Clinical Trial
Official title:
Effects of Testosterone Replacement on Pain Sensitivity and Pain Perception in Men With Chronic Pain Syndrome
This research is being done to see whether testosterone replacement in men who take
opioid-based pain medications and have low testosterone levels will show improvement in pain
tolerance, pain perception and quality of life.
Some men who take opioid-based medications (narcotics) for pain develop low testosterone
levels. Research has shown that low testosterone levels may make a person more sensitive to
pain. This means that if a person with a painful condition develops low testosterone level
as a result of his pain medications, he might become more sensitive to pain and so may need
higher doses of pain medications for pain control.
Testosterone is a male hormone that is important for sperm production and the development of
male characteristics such as muscle mass and strength, fat distribution, bone mass and sex
drive. Testosterone hormone replacement therapy has been used for decades to treat men with
low testosterone levels (male hypogonadism). Testosterone replacement therapies are
available in the form of an injection into the muscle, implants under the skin, oral
capsules taken by mouth, topical gels applied to the skin, and skin patches.
This study will use Fortesta®, a topical testosterone gel (T-gel) absorbed into the skin.
Fortesta® is currently on the market as an FDA-approved treatment of male hypogonadism (low
testosterone levels).
Men with non-cancer related pain who take opioid-based medications for pain and have low
testosterone levels may join this study. (A low testosterone level is defined as early
morning (before noon) blood testosterone level of 300 ng/dl or less, or a free testosterone
of 50 ng/dl or less)).
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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