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Completed

NCT Number: NCT00779103

Histrelin Subcutaneous Implant in Children With Central Precocious Puberty

The purpose of this study is to follow and collect additional medical and developmental information on children after histrelin subcutaneous implant therapy is discontinued.

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Key information

Conditions

Central Precocious Puberty Endocrine System Diseases Gonadal Disorders Puberty, Precocious

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Histrelin Subcutaneous Implant

Drug

histrelin subcutaneous 50 mg implant

Other names: Supprelin LA, implant therapy, histrelin implant

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Endo USA Inc., a Keenova Therapeutics Company

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2011
Study completion
2012
First posted
Oct 24, 2008
Registry last updated
Jan 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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