Trial record 5 of 145 for:    puberty

Markers of Pubertal Suppression During Therapy for Precocious Puberty

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Collaborators:
Endo Pharmaceuticals
Atlantic Center for Research
Goryeb Children’s Hospital
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT02006680
First received: December 4, 2013
Last updated: September 3, 2014
Last verified: September 2014
  Purpose

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®.


Condition
Central Precocious Puberty

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Markers of Adequate Pubertal Suppression During Supprelin LA Therapy for Central Precocious Puberty

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 20
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)
Groups/Cohorts
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   3 Years to 9 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Females diagnosed with central precocious puberty or rapidly progressive puberty based upon age at start of puberty, physical examination, serum hormone levels and bone age X-Ray will be recruited. This will be a convenience sample of children scheduled to receive Supprelin LA insert placement. The subjects will be recruited from two pediatric endocrinology clinic systems.

Criteria

Inclusion Criteria:

  • Female
  • Age: 3 to 9 years old, inclusive
  • Diagnosis of Central Precocious or Rapidly Progressive Puberty
  • Bone Age more than 1 year advanced (obtained within 6 months of screening) AND
  • Breasts Tanner II or greater AND
  • One of the following:
  • Random LH > 1 mIU/mL
  • Leuprolide-stimulated LH > 4 mIU/mL
  • Random estradiol > 20 pg/mL
  • Leuprolide-stimulated 24 hour estradiol >20 pg/mL
  • Naïve to GnRHa therapy
  • Approved to receive Supprelin LA® therapy
  • Have an acceptable surrogate capable of giving consent on the subject's behalf.

Exclusion Criteria:

  • Previous GnRHa therapy
  • Presence of peripheral precocious puberty including CAH
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02006680

Contacts
Contact: Bradley S Miller, MD, PhD 612-624-5409 mille685@umn.edu

Locations
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Bradley S Miller, MD, PhD    612-624-5409    mille685@umn.edu   
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    lawrence.silverman@atlantichealth.org   
Principal Investigator: Lawrence Silverman, MD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Endo Pharmaceuticals
Atlantic Center for Research
Goryeb Children’s Hospital
Investigators
Principal Investigator: Bradley S Miller, MD, PhD University of Minnesota - Clinical and Translational Science Institute
  More Information

Additional Information:
No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02006680     History of Changes
Other Study ID Numbers: 1303M29681
Study First Received: December 4, 2013
Last Updated: September 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Central Precocious Puberty
Suppression
Alpha Subunit
Leuprolide Stimulation Test

Additional relevant MeSH terms:
Puberty, Precocious
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 01, 2014