Phase III, Open-Label Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Children With Central Precocious Puberty
Overview
- Phase
- Phase 3
- Intervention
- Histrelin Subcutaneous Implant
- Conditions
- Central Precocious Puberty
- Sponsor
- Endo Pharmaceuticals
- Enrollment
- 36
- Primary Endpoint
- Luteinizing Hormone (LH)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
Histrelin Subcutaneous Implant (50 mg)
Subcutaneous implant designed to deliver histrelin continously for 12 months.
Intervention: Histrelin Subcutaneous Implant
Outcomes
Primary Outcomes
Luteinizing Hormone (LH)
Time Frame: Baseline - 6 Months Post Last Implant
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).
Secondary Outcomes
- Average Mean Implant Duration by Subject(12 Months)
- Testosterone(Baseline - 12 Months Post Last Implant)
- DHEA Sulfate(Baseline - 36 Months Post Last Implant)
- Follicle Stimulating Hormone (FSH)(Baseline - 6 Month Post Last Implant)
- Estradiol (MS)(Month 36 - 36 Months Post Last Implant)
- Estradiol (RIA)(Baseline - Month 24)
- Average Number of Implants Received(12 months)
- Summary of EN3326 Implantation and Explantations(Day 1 - Month 60)