Clinical Trial: Histrelin Subcutaneous Implant in Children With Central Precocious Puberty

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary: 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.
Sponsor: Endo Pharmaceuticals

Current Primary Outcome: LH suppression following stimulation with a GnRH analog (leuprolide acetate) [ Time Frame: Every 6 months until hormone suppression is discontinued ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Collect long term medical and developmental information until adulthood [ Time Frame: Up to 8-10 years post treatment ]

Original Secondary Outcome: Same as current

Information By: Endo Pharmaceuticals

Dates:
Date Received: October 22, 2008
Date Started: September 2004
Date Completion:
Last Updated: June 8, 2015
Last Verified: June 2015