Clomiphene Citrate for the Treatment of Low Testosterone Associated With Chronic Opioid Pain Medication Administration
Completed
Weill Medical College of Cornell University
Phase 2
2013-08-01
The purpose of this randomized controlled clinical trial is to evaluate the effects of
clomiphene citrate compared to placebo (substance without active medication) in men who are
taking pain medication (opioids) for chronic pain conditions and who have low blood
testosterone levels.
The condition of men having low testosterone with long-term pain medication (opioid) usage is
called opioid-induced androgen deficiency (OPIAD). Low testosterone can be caused by pain
medication effects on part of the brain (hypothalamic-pituitary axis) which ultimately result
in decreased testosterone production by the testes. Typical symptoms of low testosterone
(hypogonadism) may include decreased muscle mass, increased fat, osteoporosis, anemia,
erectile dysfunction, delayed ejaculation. In addition, men with low testosterone may
experience decreased attention, and decreased libido, fatigue, and depressed mood. Few
studies have looked at hormonal changes caused by long-term opioid usage in men.
Clomiphene citrate, a selective estrogen receptor modulator (SERM) oral medication which
inhibits estrogen effects (feedback) on the brain, has been identified by prior studies to
raise testosterone in men with low testosterone (due to reasons other than chronic pain
medication). Clomiphene citrate is also known to lead to increased sperm production in men
with low testosterone unlike testosterone topical or injection medications. Although
clomiphene citrate has been studied in hypogonadal men with beneficial outcomes and minimal
side effects, no group has previously studied clomiphene citrate as treatment in patients
with OPIAD.
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