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Histrelin Subcutaneous Implant in Children With Central Precocious Puberty

Information source: Endo Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Central Precocious Puberty

Intervention: Histrelin Subcutaneous Implant (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Endo Pharmaceuticals

Official(s) and/or principal investigator(s):
Erica A Eugster, MD, Principal Investigator, Affiliation: Indiana University School of Medicine, 705 Riley Hosp Dr, Rm 5960 Indianapolis, IN 46202

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.

Clinical Details

Official title: Phase III, Open-Label Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Children With Central Precocious Puberty

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: LH suppression following stimulation with a GnRH analog (leuprolide acetate)

Secondary outcome: Collect long term medical and developmental information until adulthood

Detailed description: Thirty-two (32) patients will receive a histrelin subdermal implant under the anesthesia deemed appropriate by the administering physician. Ten-twelve (10-12) sites will enroll 2-3 patients per site. It is anticipated that half the patients will be receiving GnRH analog treatment and the other half will be treatment naïve. All patients will undergo selective PK sampling post-implantation to assess histrelin profile. At 12 months, provided that the patient continues to meet the safety and efficacy parameters, the original implant will be removed and the patient can receive a new implant. At 13 months, patients who receive new implants will be evaluated at the study site and administratively transferred to the initial extension study. At Month 24), the implants inserted at Month 12 will be removed. At this time, patients who have completed the initial extension study and who wish to continue therapy with the histrelin implant will be eligible to receive a new (ie, third) implant and to enter an additional 12-month extended access phase at the discretion of the investigator. At Month 36, the implants inserted at Month 24 for the Extended Access Phase will be removed. At this time, patients who have completed the Extended Access Phase and who wish to continue therapy with the histrelin implant will be eligible to receive a new (ie, fourth) implant and to enter the Long Term Extended Access Phase (referred to as the Implant Treatment Phase) at the discretion of the investigator. The purpose of this phase is to provide patients with the opportunity to continue to receive a new implant at the end of each 12-month period until the patient no longer requires hormone suppression. Once implant therapy is discontinued, all patients are eligible to enter the Long Term Follow Up Phase (Post Implant Phase) of the study.

Eligibility

Minimum age: 2 Years. Maximum age: 10 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 Exclusion Criteria:

- 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

Locations and Contacts

Additional Information

Starting date: September 2004
Last updated: June 8, 2015

Page last updated: August 23, 2015

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