CLINICAL TRIALS PROFILE FOR TESTOLACTONE
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All Clinical Trials for TESTOLACTONE
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00001181 ↗ | Testolactone for the Treatment of Girls With LHRH Resistant Precocious Puberty | Completed | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Phase 2 | 1982-10-01 | 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. |
| NCT00001202 ↗ | Treatment of Boys With Precocious Puberty | Completed | 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). |
| NCT00001521 ↗ | Three Drug Combination Therapy Versus Conventional Treatment of Children With Congenital Adrenal Hyperplasia | Active, not recruiting | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Phase 2 | 1995-06-08 |
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. |
| NCT02067741 ↗ | CR1447 in Endocrine Responsive-HER2neg and TN-ARpos Breast Cancer | Active, not recruiting | Swiss Group for Clinical Cancer Research | Phase 2 | 2016-06-14 | SAKK 21/12 is a stratified, multicenter Phase II first in-human trial with transdermal CR1447 (4-OH-testosterone) and is directed to patients with endocrine responsive-HER2neg and TN-ARpos metastatic or locally advanced breast cancer. The trial will be conducted in Switzerland with max. 90 patients. CR1447 has a very good safety and tolerability profile and combines two mechanisms of action, interaction with the AR and the aromatase enzyme may have a higher activity than drugs with a single mechanism and might offer the possibility of non-chemotherapy based endocrine therapy to the limited treatment options in TN-ARpos BC. Transdermal application of CR1447 might have the advantage to continuously release of 4-OHT into the blood stream, thus omitting a first pass effect. In Phase II the main objective is to assess activity and to determine the efficacy and tolerability of CR1447. Phase II will consist of two strata, into which patients will be stratified according to their hormonal receptor status: Stratum A for patients with endocrine responsive-HER2neg disease, regardless of their AR status and Stratum B for patients with triple-negative and determined ARpos disease. Patients with triple-negative disease tested negative for AR will be excluded from the trial. In both strata patients will be treated with 400 mg of CR1447 until disease progression, patients' wish or physicians' decision to end treatment. Biopsies of one defined metastatic lesion in those patients who gave informed consent will be performed at baseline and within the third week of treatment with CR1447. Measurement of AR expression, expression of downstream targets of ERα, ERβ, PR, AR, angiogenesis and other translational studies as described in this protocol should help confirming the hypothesis of an increased benefit of CR1447 due to its dual action, efficacy of topical application, tolerability and in deciding whether one should proceed to a large randomized trial. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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