NEWS HIGHLIGHTS
Published Studies Related to Teslac (Testolactone)
Sertoli cell tumor causing prepubertal gynecomastia in a boy with peutz-jeghers syndrome: the outcome of 1-year treatment with the aromatase inhibitor testolactone. [2005]
Peutz-Jeghers syndrome (PJS) is a rare disorder characterized by benign intestinal hamartomatous polyps and mucocutaneous pigmentation, and with an increased risk for intestinal and extra-intestinal neoplasms. Sertoli cell tumors in boys with PJS have been increasingly recognized as a cause of prepubertal gynecomastia...
Clinical Trials Related to Teslac (Testolactone)
Testolactone for the Treatment of Girls With LHRH Resistant Precocious Puberty [Completed]
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.
Treatment of Boys With Precocious Puberty [Completed]
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).
Three Drug Combination Therapy Versus Conventional Treatment of Children With Congenital Adrenal Hyperplasia [Active, not recruiting]
This study was developed to determine if a combination of four drugs (flutamide,
testolactone, reduced hydrocortisone dose, and fludrocortisone) can normalize growth in
children with congenital adrenal hyperplasia.
The study will take 60 children, boys and girls and divide them into 2 groups based on the
medications given. Group one will receive the new four- drug combination. Group two will
receive the standard treatment for congenital adrenal hyperplasia (hydrocortisone and
fludrocortisone).
The boys in group one will take the medication until the age of 14 at which time they will
stop taking the four drug combination and begin receiving the standard treatment for
congenital adrenal hyperplasia. Girls in group one will take the four drug combination until
the age of 13, at which time they will stop and begin receiving the standard treatment for
congenital adrenal hyperplasia plus flutamide. Flutamide will be given to the girls until
six months after their first menstrual period.
All of the children will be followed until they reach their final adult height. The
effectiveness of the treatment will be determined by measuring the patient's adult height,
body mass index, and bone density.
Sex Steroids and the Serotonin Transporter [Recruiting]
The aim of this study is to prove the influence of the sex steroid hormones estrogen,
progesterone and testosterone on the serotonin transporter (5-HTT) binding using positron
emission tomography (PET) and the selective radioligand [11C]DASB. Specifically, the 5-HTT
binding will be quantified before and after hormone therapy underwent by 10 male-to-female
(MtF) and 10 female-to-male (FtM) transsexuals urging for hormone treatment. The high-level,
long-term administration of opsite sex steroid hormones in transsexuals provide the unique
opportunity to investigate the influence of sex steroid hormones on the serotonergic system.
Since the serotonin transporter serves as a primary target molecule for antidepressant
treatment, the results of the study will be of benefit for the assessment of the clinical
relevance of estrogen and testosterone as modulatory and neuroactive agents.
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