Ignite Creation Date:
2024-05-05 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 9:57 AM
Study NCT ID:
NCT00779103
Status:
COMPLETED
Last Update Posted:
2021-01-08
First Post:
2008-10-22
Brief Title:
Histrelin Subcutaneous Implant in Children With Central Precocious Puberty
Sponsor:
Endo Pharmaceuticals
Organization:
Endo Pharmaceuticals
Study Overview
Official Title:
Phase III Open-Label Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Children With Central Precocious Puberty
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None