Markers of Pubertal Suppression During Therapy for Precocious Puberty
The best way to measure whether treatment of children with central precocious puberty is working is to do a hormone stimulation test (leuprolide stimulation test) that requires injection of a medication and multiple blood draws to see if the hormonal response is suppressed (blocked). The hypothesis of this study is that random measurement of the free alpha subunit of pituitary glycoprotein, a protein related to the pituitary hormones that stimulate puberty, will provide an adequate alternative to the leuprolide stimulation testfor monitoring efficacy of pubertal suppression with Supprelin LA®.
Central Precocious Puberty
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Markers of Adequate Pubertal Suppression During Supprelin LA Therapy for Central Precocious Puberty|
- Sensitivity and specificity of free alpha subunit of pituitary glycoprotein to identify subjects with appropriate pubertal suppression. [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]The primary outcome of the study will be the sensitivity and specificity of a subject having elevated random FASPG values (> 0.6 ng/mL) to identify subjects who are appropriately suppressed based upon a leuprolide-stimulated LH <4 mIU/mL. This outcome will be based upon results of puberty hormone suppression testing obtained 28-97 days after placement of the Supprelin LA insert.
Biospecimen Retention: None Retained
Serum will be collected at four different time points.
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Children with Central Precocious Puberty
Children with Central Precocious Puberty will have hormonal testing of markers of puberty up to 30 days prior to placement of a Supprelin LA insert and 28-97 days after placement of the Supprelin LA insert.
During clinical trials of Supprelin LA®, leuprolide stimulation tests were performed to determine adequacy of suppression. However, the use of this stimulation test to monitor suppression requires an expensive medication and collection of multiple blood samples. Alternative methods of monitoring pubertal suppression during gonadotropin releasing hormone receptor agonist (GnRHa) therapy have included both random and trough levels of Luteinizing Hormone (LH), estradiol or inhibin B. Recently, the free alpha subunit of pituitary glycoprotein (FASPG) has also been shown to be a potentially useful marker of hormonal suppression (Hirsch HJ, et al, JCEM 95:2841, 2010) as it undergoes a paradoxical rise following initiation of therapy, and reverts to baseline upon completion.
In this investigator-initiated pilot study we will evaluate novel markers of pubertal suppression in children receiving standard of care gonadotropin releasing hormone receptor agonist therapy for the treatment of central precocious puberty. Children with central precocious puberty who have selected treatment with Supprelin LA will undergo hormonal testing of markers of pubertal activity before and after placement of the Supprelin LA insert.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02006680
|Contact: Bradley S Miller, MD, PhDfirstname.lastname@example.org|
|United States, Minnesota|
|University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55454|
|Contact: Bradley S Miller, MD, PhD 612-624-5409 email@example.com|
|Principal Investigator: Bradley S Miller, MD, PhD|
|United States, New Jersey|
|Atlantic Center for Research||Recruiting|
|Morristown, New Jersey, United States, 07960|
|Contact: Lawrence Silverman, MD 973-971-4340 firstname.lastname@example.org|
|Principal Investigator: Lawrence Silverman, MD|
|Principal Investigator:||Bradley S Miller, MD, PhD||University of Minnesota - Clinical and Translational Science Institute|