Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001181
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Testolactone for the Treatment of Girls With LHRH Resistant Precocious Puberty
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Testolactone Treatment of Girls With LHRH Analog-Resistant Precocious Puberty Due to Autonomous Non-Neoplastic Ovarian Estrogen Secretion
Status:
COMPLETED
Status Verified Date:
2003-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 childrens 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
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
Detailed Description:
Females with precocious puberty who have low levels of serum gonadotropins and high levels of serum estrogen or those who have demonstrated an inadequate clinical response to therapy with the luteinizing hormone releasing hormone analog Lupron Histerelin Deslorelin will be treated with testolactone Testolactone inhibits aromatase the last enzyme of estrogen biosynthesis The goal of treatment is to inhibit estrogen secretion and thus delay secondary sexual maturation and epiphyseal closure until the normal age The intent is to alleviate the psychological problems and short stature frequently associated with this disorder Throughout therapy patients will receive frequent clinical hormonal and toxicological monitoring The initial treatment period will be six months If patients respond to the treatment and tolerate it well testolactone will be given until puberty is desired Patients who exhibit pubertal levels of serum gonadotropins during testolactone therapy indicating the onset of secondary gonadotropin-dependent puberty will receive an LHRH analog in addition to testolactone
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 82-CH-0165 | None | None | None |