Phase 3
Completed N=36
Histrelin Subcutaneous Implant in Children With Central Precocious Puberty
Source: ClinicalTrials.gov NCT00779103 ↗Enrolled (actual)
36
Serious AEs
9.7%
Results posted
Jan 2021
Primary outcomePrimary: Luteinizing Hormone (LH) — 0.88; 0.53; 0.07; 0.50 MIU/ML
◆ Published Evidence
Established
62citations · ~6 / year
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.
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.
Linked Publications (2)
-
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.
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Random unstimulated pediatric luteinizing hormone levels are not reliable in the assessment of pubertal suppression during histrelin implant therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Luteinizing Hormone (LH) |
0.88; 0.53; 0.07; 0.50; -0.37; 0.39 | — |
| SECONDARY Follicle Stimulating Hormone (FSH) |
2.26; 1.60; -0.20; 1.08; -1.18; 1.36 | — |
| SECONDARY Testosterone |
10.95; 6.50; -4.45; 8.25; -2.70; 12.67 | — |
| SECONDARY DHEA Sulfate |
61.69; 70.88; 11.67; 66.92; 6.08; 71.22 | — |
| SECONDARY Estradiol (MS) |
0.46; 0.38; 0.52; 0.47; 0.50; 0.21 | — |
| SECONDARY Estradiol (RIA) |
1.58; 0.50; 0.00; 0.58; -1.00; 0.55 | — |
| SECONDARY Average Number of Implants Received |
3.5 | — |
| SECONDARY Average Mean Implant Duration by Subject |
12.62 | — |
| SECONDARY Summary of EN3326 Implantation and Explantations |
31; 31; 31; 31; 22; 22 | — |
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
Data sourced from ClinicalTrials.gov (NCT00779103) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.