Phase 3
Completed N=64
Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty
Precocious Puberty, Central
Source: ClinicalTrials.gov NCT02452931 ↗
Enrolled (actual)
64
Serious AEs
1.6%
Results posted
May 2020
Primary outcomePrimary: Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 6 Months. — 54 Participants
◆ Published Evidence
Established
35citations · ~6 / year
Phase 3 Trial of a Small-volume Subcutaneous 6-Month Duration Leuprolide Acetate Treatment for Central Precocious Puberty.
Summary
This study determines the effectiveness of leuprolide acetate 45 mg for injectable suspension for treatment of children with Central Precocious Puberty.
Linked Publications
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Phase 3 Trial of a Small-volume Subcutaneous 6-Month Duration Leuprolide Acetate Treatment for Central Precocious Puberty.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 6 Months. |
54 | — |
| SECONDARY Percentage of Subjects With Suppression of Luteinizing Hormone Measured by Blood Levels. |
51; 54; 50; 50 | — |
| SECONDARY Changes in Height Velocity (Growth Rate) |
8.89; 8.30; 6.66; 6.90; 6.48; 6.23 | — |
| SECONDARY Bone Age Ratio to Chronological Age at Time of Measurement |
1.39; 1.34; 1.32; 1.30; 1.36 | — |
| SECONDARY Percent Change From Baseline in Height |
0.5; 1.4; 1.9; 2.3; 3.3; 3.9 | — |
| SECONDARY Tanner Scores: Boys - Development of External Genitalia |
3.0; 2.5; 2.5; 2.5; 2.0 | — |
| SECONDARY Tanner Scores: Boys - Development of External Genitalia (Change From Baseline) |
-0.5; -0.5; -0.5; -1.0 | — |
| SECONDARY Tanner Scores: Boys and Girls - Pubic Hair |
2.3; 2.4; 2.5; 2.3; 2.4 | — |
| SECONDARY Tanner Scores: Boys and Girls - Pubic Hair (Change From Baseline) |
0.1; 0.1; 0.1; 0.1 | — |
| SECONDARY Tanner Scores: Girls - Breast Development |
3.2; 2.7; 2.6; 2.5; 2.4 | — |
| SECONDARY Tanner Scores: Girls - Breast Development (Change From Baseline) |
-0.5; -0.6; -0.6; -0.7 | — |
Eligibility Criteria
Inclusion Criteria
- Females age 2 to 8 years (inclusive) or males age 2 to 9 years (inclusive)
- Confirmed diagnosis of CPP within 12 months of Baseline Visit (Day 0) but have not received prior GnRH agonist treatment for CPP
- Pubertal-type LH response following an abbreviated GnRHa stimulation test before treatment initiation
- Clinical evidence of puberty, defined as Tanner stage ≥ 2 for breast development in females or testicular volume ≥ 4 mL in males
- Difference between bone age (Greulich and Pyle method) and chronological age ≥ 1 year
Exclusion Criteria
- Gonadotropin-independent (peripheral) precocious puberty
- Prior or current GnRH treatment for CPP
- Prior or current therapy with medroxyprogesterone acetate, growth hormone or insulin-like growth factor-1 (IGF-1)
- Diagnosis of short stature (ie, 2.25 standard deviations (SD) below the mean height for age)
- Known history of seizures, epilepsy, and/or central nervous system disorders that may be associated with seizures or convulsions
- Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study
Data sourced from ClinicalTrials.gov (NCT02452931) 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.