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).
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.
Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data.
The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free.
We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models.
By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice.
thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user.
Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
Alerts Available With Subscription
Alerts are available for users with active subscriptions.
