Markers of Pubertal Suppression During Therapy for Precocious Puberty

NCT ID: NCT02006680

Last Updated: 2018-10-15

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 4 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-12-31

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.

Conditions

Central Precocious Puberty

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Endo Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Atlantic Center for Research

UNKNOWN

Sponsor Role: collaborator

Goryeb Children's Hospital

UNKNOWN

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bradley S Miller, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Atlantic Center for Research

Morristown, New Jersey, United States

Countries

United States

Other Identifiers

1303M29681

Identifier Type: -

Identifier Source: org_study_id