NCT00779103

Brief Summary

The purpose of this study is to follow and collect additional medical and developmental information on children after histrelin subcutaneous implant therapy is discontinued.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2004

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
8.8 years until next milestone

Results Posted

Study results publicly available

January 8, 2021

Completed
Last Updated

January 8, 2021

Status Verified

October 1, 2020

Enrollment Period

6.9 years

First QC Date

October 22, 2008

Results QC Date

October 29, 2020

Last Update Submit

December 15, 2020

Conditions

Central Precocious Puberty

Keywords

pubertyprecocious pubertyearly pubertyearly onset pubertyhistrelinhistrelin subcutaneous implantimplant therapy

Outcome Measures

Primary Outcomes (1)

  • Luteinizing Hormone (LH)

    The suppression of gonadotropins (luteinizing hormone and follicle stimulating hormone) and gonadal sex steroids (estrogen in girls and testosterone in boys, respectively) on treatment.(LH suppression is defined as a peak LH \< 4 mIU/mL following stimulation with the GnRH analog).

    Baseline - 6 Months Post Last Implant

Secondary Outcomes (8)

  • Follicle Stimulating Hormone (FSH)

    Baseline - 6 Month Post Last Implant

  • Testosterone

    Baseline - 12 Months Post Last Implant

  • DHEA Sulfate

    Baseline - 36 Months Post Last Implant

  • Estradiol (MS)

    Month 36 - 36 Months Post Last Implant

  • Estradiol (RIA)

    Baseline - Month 24

  • +3 more secondary outcomes

Study Arms (1)

Histrelin Subcutaneous Implant (50 mg)

EXPERIMENTAL

Subcutaneous implant designed to deliver histrelin continously for 12 months.

Drug: Histrelin Subcutaneous Implant

Interventions

Histrelin Subcutaneous ImplantDRUG

histrelin subcutaneous 50 mg implant

Also known as: Supprelin LA, implant therapy, histrelin implant
Histrelin Subcutaneous Implant (50 mg)

Eligibility Criteria

Age2 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Pre-treated or treatment naive patients with gonadotropin-dependent precocious puberty
  • Pre-treatment pubertal type response of LH to a stndard GnRH stimulation test before initiation of treatment

You may not qualify if:

  • Children who are less than 2 years of age at enrollment
  • Children whose chronological age is greater than 8 years (naive) and 10 years (pre-treated) for girls or 9 years (naive) and 11 years (pre-treated) for boys at the onset of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Silverman LA, Neely EK, Kletter GB, Lewis K, Chitra S, Terleckyj O, Eugster EA. Long-Term Continuous Suppression With Once-Yearly Histrelin Subcutaneous Implants for the Treatment of Central Precocious Puberty: A Final Report of a Phase 3 Multicenter Trial. J Clin Endocrinol Metab. 2015 Jun;100(6):2354-63. doi: 10.1210/jc.2014-3031. Epub 2015 Mar 24.

    PMID: 25803268DERIVED

  • Neely EK, Silverman LA, Geffner ME, Danoff TM, Gould E, Thornton PS. Random unstimulated pediatric luteinizing hormone levels are not reliable in the assessment of pubertal suppression during histrelin implant therapy. Int J Pediatr Endocrinol. 2013 Dec 2;2013(1):20. doi: 10.1186/1687-9856-2013-20.

    PMID: 24295437DERIVED

MeSH Terms

Conditions

Puberty, Precocious

Interventions

histrelin

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Results Point of Contact

Title
Saji Vijayan, MBBS
Organization
Endo Pharmaceuticals
ClinicalTrials@Endo.com
800-462-3636

Study Officials

  • Erica A Eugster, MD

    Indiana University School of Medicine, 705 Riley Hosp Dr, Rm 5960 Indianapolis, IN 46202

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2008

First Posted

October 24, 2008

Study Start

September 1, 2004

Primary Completion

August 1, 2011

Study Completion

April 1, 2012

Last Updated

January 8, 2021

Results First Posted

January 8, 2021

Record last verified: 2020-10