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
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