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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Histrelin Subcutaneous Implant in Children With Central Precocious Puberty

NCTNCT00779103 (opens ClinicalTrials.gov in a new tab)Other idEN3326-300Former03-CPP-HIS-300
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
36 participants (actual)
Sponsor
Endo USA Inc., a Keenova Therapeutics Company · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
Not stated
Start
Sept 2004
Primary completion
Aug 2011
Completion
Apr 2012
First posted
24 Oct 2008 (estimated)
Last update posted
8 Jan 2021
Conditions
Central Precocious Puberty

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20042006200820102012
  1. Ph 3

    Histrelin Subcutaneous Implant in Children With Central Precocious Puberty

    NCT00779103

    Sept 2004 to Apr 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • Histrelin Subcutaneous ImplantDrug

Arms1

  • Experimental

    Histrelin Subcutaneous Implant (50 mg)

    Subcutaneous implant designed to deliver histrelin continously for 12 months.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Luteinizing Hormone (LH)

    Time frame · Baseline - 6 Months Post Last Implant

    Registry description

    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(8)

  1. Follicle Stimulating Hormone (FSH)

    Time frame · Baseline - 6 Month Post Last Implant

    Registry description

    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

    Registry description

    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

    Registry description

    DHEA=Dehydroepiandrosterone

  4. Estradiol (MS)

    Time frame · Month 36 - 36 Months Post Last Implant

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline - 6 Months Post Last Implant

Luteinizing Hormone (LH)

GroupValue (MIU/ML)Spread
Observed Value0.881.244
Change From Baselinenot posted–
Secondary and other outcome results(7)
Secondary outcomeMean· Baseline - 6 Month Post Last Implant

Follicle Stimulating Hormone (FSH)

GroupValue (MIU/ML)Spread
Observed Value2.261.656
Change From Baselinenot posted–
Secondary outcomeMean· Baseline - 12 Months Post Last Implant

Testosterone

GroupValue (NG/DL)Spread
Observed Value10.951.485
Change From Baselinenot posted–
Secondary outcomeMean· Baseline - 36 Months Post Last Implant

DHEA Sulfate

GroupValue (UG/DL)Spread
Observed Value61.6936.526
Change From Baselinenot posted–
Secondary outcomeMean· Month 36 - 36 Months Post Last Implant

Estradiol (MS)

GroupValue (NG/DL)Spread
Observed Value0.460.277
Secondary outcomeMean· Baseline - Month 24

Estradiol (RIA)

GroupValue (NG/DL)Spread
Observed Value1.581.754
Change From Baselinenot posted–
Secondary outcomeMean· 12 months

Average Number of Implants Received

GroupValue (Implants)Spread
Histrelin Subcutaneous Implant (50 mg)3.51.36
Secondary outcomeMean· 12 Months

Average Mean Implant Duration by Subject

GroupValue (Months)Spread
Histrelin Subcutaneous Implant (50 mg)12.620.469

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Overall - Histrelin Subcutaneous Implant (50 mg)Subcutaneous implant designed to deliver histrelin continously for 12 months. Histrelin Subcutaneous Implant: histrelin subcutaneous 50 mg implant1 / 313 / 3131 / 31

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Clinical trial · 2015

8 results

Long-Term Continuous Suppression With Once-Yearly Histrelin Subcutaneous Implants for the Treatment of Central Precocious Puberty: A Final Report of a Phase 3 Multicenter Trial.

Silverman et al. 2015The Journal of clinical endocrinology and metabolismcited by 44

PMID 25803268PMC4504932DOI 10.1210/jc.2014-3031PUB-25803268

Rights unknown8 results
Source linkSee results (8)

PubMed tag: none · 2013

6 results

Random unstimulated pediatric luteinizing hormone levels are not reliable in the assessment of pubertal suppression during histrelin implant therapy.

Neely et al. 2013International journal of pediatric endocrinologycited by 26

PMID 24295437PMC4220797DOI 10.1186/1687-9856-2013-20PUB-24295437

CC BY6 results
Download PDFSee results (6)

Eligibility

Who could join, as posted.

Sex
All
Age
from 2 Years up to 10 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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