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Histrelin Subcutaneous Implant in Children With Central Precocious Puberty

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ClinicalTrials.gov Identifier: NCT00779103
Recruitment Status : Completed
First Posted : October 24, 2008
Results First Posted : January 8, 2021
Last Update Posted : January 8, 2021
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Central Precocious Puberty Drug: Histrelin Subcutaneous Implant Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III, Open-Label Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Children With Central Precocious Puberty
Study Start Date : September 2004
Actual Primary Completion Date : August 2011
Actual Study Completion Date : April 2012


Arm Intervention/treatment
Experimental: Histrelin Subcutaneous Implant (50 mg)
Subcutaneous implant designed to deliver histrelin continously for 12 months.
Drug: Histrelin Subcutaneous Implant
histrelin subcutaneous 50 mg implant
Other Names:
  • Supprelin LA
  • implant therapy
  • histrelin implant




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Follicle Stimulating Hormone (FSH) [ Time Frame: Baseline - 6 Month 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).

  2. Testosterone [ Time Frame: Baseline - 12 Months Post Last Implant ]
    Long-term treatment with histrelin acetate suppresses the LH response to GnRH causing LH levels to decrease to prepubertal levels within 1 month of treatment. As a result, serum concentrations of sex steroids (estrogen or testosterone) also decrease. Testosterone suppression is defined as serum testosterone < 30.0 ng/dL (0.8 nmol/L) in boys following the induction of suppression. One black female participant age 8.9 years old had a testosterone value of 11ng/dL at visit 4 (month 6).

  3. DHEA Sulfate [ Time Frame: Baseline - 36 Months Post Last Implant ]
    DHEA=Dehydroepiandrosterone

  4. Estradiol (MS) [ Time Frame: Month 36 - 36 Months Post Last Implant ]
    Long-term treatment with histrelin acetate suppresses the LH response to GnRH causing LH levels to decrease to prepubertal levels within 1 month of treatment. As a result, serum concentrations of sex steroids (estrogen or testosterone) also decrease. Estradiol suppression is defined as serum estradiol in the assay specific range < 20 pg/mL (73 pmol/L) in girls following the induction of suppression.

  5. Estradiol (RIA) [ Time Frame: Baseline - Month 24 ]
    Long-term treatment with histrelin acetate suppresses the LH response to GnRH causing LH levels to decrease to prepubertal levels within 1 month of treatment. As a result, serum concentrations of sex steroids (estrogen or testosterone) also decrease. Estradiol suppression is defined as serum estradiol in the assay specific range < 20 pg/mL (73 pmol/L) in girls following the induction of suppression.

  6. Average Number of Implants Received [ Time Frame: 12 months ]
    There were 2 implants received that were not removed during the study and were excluded from this analysis due to unknown duration of treatment.

  7. Average Mean Implant Duration by Subject [ Time Frame: 12 Months ]
    There were 2 implants received that were not removed during the study and were excluded from this analysis due to unknown duration of treatment.

  8. Summary of EN3326 Implantation and Explantations [ Time Frame: Day 1 - Month 60 ]
    Once the female participants reached 11 years of age and the male participants reached 12 years of age or the investigator determined that subjects no longer required hormone suppression, participants underwent final explantation and were eligible to continue into an optional Long Term Follow Up Phase (Post Implant Treatment Phase) for up to 5 years. The purpose of the optional Long Term Follow Up Phase was to collect additional medical and developmental information, such as onset of menses and final adult height after hormone suppression was discontinued.



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Ages Eligible for Study:   2 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00779103


Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
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Principal Investigator: Erica A Eugster, MD Indiana University School of Medicine, 705 Riley Hosp Dr, Rm 5960 Indianapolis, IN 46202
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00779103    
Other Study ID Numbers: EN3326-300Former03-CPP-HIS-300
First Posted: October 24, 2008    Key Record Dates
Results First Posted: January 8, 2021
Last Update Posted: January 8, 2021
Last Verified: October 2020
Keywords provided by Endo Pharmaceuticals:
puberty
precocious puberty
early puberty
early onset puberty
histrelin
histrelin subcutaneous implant
implant therapy
Additional relevant MeSH terms:
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Puberty, Precocious
Gonadal Disorders
Endocrine System Diseases