Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Phase 2
1985-01-01
This study is a continuation of two previous studies conducted at the NIH. The first study ,
"Treatment of True Precocious Puberty with a Long-Acting Lutenizing Hormone Releasing Hormone
Analog (D-Trp(6)-Pro(9)-Net-LHRH)" had less than optimal results. Some patients, all of whom
were diagnosed with familial isosexual precocious puberty, had an inadequate response to the
medication and were observed to have high levels of testosterone, advanced bone aging, and
other complications of the disease. As a result these patients were enrolled in a second
study
In the second study, "Spironolactone Treatment for Boys with Familial Isosexual Precocious
Puberty", - the patients received another medication, spironolactone (Aldactone). The drug
blocked the effects of testosterone, -but bone age advancement did not improve. Some patients
began experiencing gynecomastia (an abnormal growth of the male breasts). Researchers believe
these may be the effects of elevated levels of estrodiol (a form of the female hormone,
estrogen).
In the present study, testolactone is added to the drug regimen to block the production of
estrogen. The study therefore uses spironolactone to prevent the action of the male hormones
(androgen) and testolactone to block the production of female hormones (estrogen).
Deslorelin, an LHRH analog which works by turning off true (central) puberty, is added to the
drug regimen once true puberty begins. This is because it is know that boys with familial
male precocious puberty go into true puberty too early (despite treatment with spironolactone
and testolactone), and when that happens, the spironolactone and testolactone are no longer
as effective. The goal of the treatment is to delay sexual development until a more
appropriate age and prevent short adult stature (height).
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