Precocious Puberty Clinical Trial
Official title:
Spironolactone and Testolactone Treatment of Boys With Familial Isosexual Precocious Puberty
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).
Status | Completed |
Enrollment | 80 |
Est. completion date | January 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Male |
Age group | N/A and older |
Eligibility |
INCLUSION CRITERIA: Patients with familial male precocious puberty will be admitted to the Clinical Center. In order to be eligible for the study, the following criteria will be met: Boys 10 years of age or less. Tanner II to IV pubertal development. Unfused epiphyses by bone films. Evidence that precocious puberty is not secondary to another recognized cause of pseudopuberty: 1. We will exclude congenital adrenal hyperplasia, and document pretreatment androgen levels, by a 1-hour ACTH test, which will include measurement of 11-deoxycortisol and 17-OH-progesterone at 0 and 60 minutes. 2. We will exclude tumor of adrenal or testes by physical exam, ultrasound, and measurement of adrenal androgens (DHA, DHAS, androstenedione). Elevated testosterone levels measured at 10 am, 2pm, 10 pm and 2 am over a 24 hour period. |
Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | National Institute of Child Health and Human Development (NICHD) | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Laue L, Jones J, Barnes KM, Cutler GB Jr. Treatment of familial male precocious puberty with spironolactone, testolactone, and deslorelin. J Clin Endocrinol Metab. 1993 Jan;76(1):151-5. — View Citation
Laue L, Kenigsberg D, Pescovitz OH, Hench KD, Barnes KM, Loriaux DL, Cutler GB Jr. Treatment of familial male precocious puberty with spironolactone and testolactone. N Engl J Med. 1989 Feb 23;320(8):496-502. — View Citation
Shenker A, Laue L, Kosugi S, Merendino JJ Jr, Minegishi T, Cutler GB Jr. A constitutively activating mutation of the luteinizing hormone receptor in familial male precocious puberty. Nature. 1993 Oct 14;365(6447):652-4. — View Citation
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