Markers of Pubertal Suppression During Therapy for Precocious Puberty

NCT02006680 | Terminated DMC

• 1 other identifier: 1303M29681
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 2

Brief Summary

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®.

Conditions

Central Precocious Puberty

Keywords

Central Precocious Puberty; Suppression; Alpha Subunit; Leuprolide Stimulation Test

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of free alpha subunit of pituitary glycoprotein to identify subjects with appropriate pubertal suppression.

  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.

  Up to 12 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Previous GnRHa therapy
• Presence of peripheral precocious puberty including CAH

Sponsors & Collaborators

• University of Minnesota: lead
• Endo Pharmaceuticals: collaborator
• Atlantic Center for Research: collaborator
• Goryeb Children's Hospital: collaborator

Study Sites (2)

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

Atlantic Center for Research

Morristown, New Jersey, 07960, United States

Location

Biospecimen

Retention: NONE RETAINED

Serum will be collected at four different time points.

MeSH Terms

Conditions

Puberty, Precocious

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Study Officials

• Bradley S Miller, MD, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2013
• First Posted: December 10, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 15, 2018

Record last verified: 2018-10

Locations

US (2)