Precocious Puberty Clinical Trial
Official title:
Testolactone Treatment of Girls With LHRH Analog-Resistant Precocious Puberty Due to Autonomous, Non-Neoplastic Ovarian Estrogen Secretion
The normal changes of puberty, such as breast enlargement, pubic hair and menstrual periods,
usually begin between the ages of 9 and 15 in response to hormones produced in the body.
Some children's bodies produce these hormones before the normal age and start puberty too
early. This condition is known as precocious puberty.
The hormones responsible for the onset of puberty come from the pituitary gland and the
ovaries. The hormones from the pituitary gland act on the ovaries to produce different
hormones that cause the breasts to grow, pubic hair to develop, and menstruation.
Many children with precocious puberty can be treated with a medication known as lutenizing
hormone-releasing hormone analog (Lupron, Histerelin, Deslorelin). This drug is made in a
laboratory and is designed to act like the natural hormone LHRH, which is made in the
pituitary gland. The drug causes the pituitary gland to decrease the amount of hormones it
is releasing and thereby decrease the amount of hormones released by the ovaries. However,
some girls already have low levels of pituitary hormones and yet their ovaries still produce
hormones. Researchers do not believe that LHRH analog therapy will work for these children.
Testolactone is a drug that acts directly on the ovary. It works by preventing the last step
of estrogen production in the ovary. The goal of this treatment is to stop estrogen
production and delay the onset of puberty until the normal age.
Researchers will give patients with LHRHa resistant precocious puberty Testolactone for six
months. If the initial treatment is successful and patients do not experience very bad side
effects, they will continue to receive the medication until puberty is desired. Throughout
the therapy patients will receive frequent monitoring of their general state of health,
hormone levels, and medication levels.
Status | Completed |
Enrollment | 100 |
Est. completion date | May 2003 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
INCLUSION CRITERIA: Patients are girls aged 1-8 years (on entry to the study) with gonadotropin-independent precocious puberty. All ethnic groups are included. EXCLUSION CRITERIA: Males are excluded, as are patients with clinically-significant hepatic and/or renal impairment (testolactone is metabolized via the liver and kidneys). |
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,
Boyar RM, Finkelstein JW, David R, Roffwarg H, Kapen S, Weitzman ED, Hellman L. Twenty-four hour patterns of plasma luteinizing hormone and follicle-stimulating hormone in sexual precocity. N Engl J Med. 1973 Aug 9;289(6):282-6. — View Citation
Boyar RM, Rosenfeld RS, Kapen S, Finkelstein JW, Roffwarg HP, Weitzman ED, Hellman L. Human puberty. Simultaneous augmented secretion of luteinizing hormone and testosterone during sleep. J Clin Invest. 1974 Sep;54(3):609-18. — View Citation
Weinstein LS, Shenker A, Gejman PV, Merino MJ, Friedman E, Spiegel AM. Activating mutations of the stimulatory G protein in the McCune-Albright syndrome. N Engl J Med. 1991 Dec 12;325(24):1688-95. — View Citation
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