Markers of Pubertal Suppression During Therapy for Precocious Puberty
|ClinicalTrials.gov Identifier: NCT02006680|
Recruitment Status : Unknown
Verified September 2014 by University of Minnesota - Clinical and Translational Science Institute.
Recruitment status was: Recruiting
First Posted : December 10, 2013
Last Update Posted : September 4, 2014
|Condition or disease|
|Central Precocious Puberty|
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.
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Markers of Adequate Pubertal Suppression During Supprelin LA Therapy for Central Precocious Puberty|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2014|
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.
- Sensitivity and specificity of free alpha subunit of pituitary glycoprotein to identify subjects with appropriate pubertal suppression. [ Time Frame: Up to 12 months ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|