Markers of Pubertal Suppression During Therapy for Precocious Puberty

Terminated

• Conditions: Central Precocious Puberty

• Registration Number: NCT02006680
• Lead Sponsor: University of Minnesota

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®.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-04
• Study First Submitted QC: 2013-12-04
• Study First Posted: 2013-12-10
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 4

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (2)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Atlantic Center for Research; 🇺🇸 Morristown, New Jersey, United States