Clinical trial NCT01689896: Testosterone and Pain Sensitivity
Official title: Effects of Testosterone Replacement on Pain Sensitivity and Pain Perception in Men With Chronic Pain Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Low Testosterone
Hypogonadism
Pain
Keywords: Hypogonadism
Low testosterone
Pain
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Endo Pharmaceuticals
First posted: 2012-09-21
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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)).


Eligibility criteria: Inclusion Criteria:

* Men
* 18 Years of Age and Older
* Serum total testosterone level \<300 ng/dl or free testosterone \< 50 pg/ml
* Consumption of at least 10 mg of hydrocodone (or analgesic equivalent of another opioid) for at least 4 weeks
* Absence of hospitalization in past 2 months
* No acute illness in past 2 months
* No prior history of any form of hypogonadism
* No current anabolic therapy (growth hormone, DHEA, etc)
* No current use or consumption in past 2 months of glucocorticoids and melatonin
* Normal digital rectal examination
* Normal PSA level

Exclusion Criteria:

* Liver enzymes \>3 times upper limit of normal
* Serum creatinine \> 2 times upper limit of normal
* Neurological disease
* Active psychiatric illness
* Any addictive and/or illicit drug use
* Alcoholism (\>10 drinks/week)
* Patients currently receiving glucocorticoids, melatonin or anabolic agents
* Hospitalization in past 2 months
* Acute illness in 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
* Any cancer or cancer related pain
* History of alcohol abuse
* Known peripheral neuropathy (any etiology) or peripheral vascular disease (including Raynaud's disease), which may interfere with pain testing
* Concurrent warfarin treatment

Primary outcomes:
measure: Pain Tolerance - CPT
timeFrame: 18 weeks
measure: Pain Tolerance - PPT
timeFrame: 18 Weeks
measure: QOL
timeFrame: 18 Weeks
measure: Pain Tolerance - TPPT
timeFrame: 18 Weeks
Secondary outcomes:
measure: Hormonal Outcomes
timeFrame: 18 Weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Medical Institutions
state: Maryland
Study officials:
References: