Phase 3
N=45
A Study to Evaluate Leuprolide Acetate 45 mg 6-Month Formulation in Children With Central Precocious Puberty (CPP)
Central Precocious Puberty (CPP)
Bottom Line
View on ClinicalTrials.gov: NCT03695237 ↗Enrolled (actual)
45
Serious AEs
2.2%
Results posted
May 2023
Primary outcome: Primary: Percentage of Participants With Suppression of Peak Gonadotropin-releasing Hormone Agonist (GnRHa)-Stimulated Luteinizing Hormone (LH) to Less Than 4 mlU/mL at Week 24 — 94.4; 81.5; 86.7 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Leuprolide Acetate (LA) (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Suppression of Peak Gonadotropin-releasing Hormone Agonist (GnRHa)-Stimulated Luteinizing Hormone (LH) to Less Than 4 mlU/mL at Week 24 |
94.4; 81.5; 86.7 | — |
| SECONDARY Part 1: Percentage of Participants With Suppression of Peak GnRHa-stimulated LH to Less Than 4 mlU/mL at Weeks 12, 20, 44, and 48 |
83.3; 88.9; 86.7; 94.4; 85.2; 88.9 | — |
| SECONDARY Part 1: Percentage of Female Participants With Suppression of Basal Estradiol to < 20 pg/mL at Weeks 12, 20, 24, 44, and 48 |
100.0; 95.5; 97.4; 100.0; 95.7; 97.4 | — |
| SECONDARY Part 1: Percentage of Male Participants With Suppression of Basal Testosterone to < 30 ng/dL at Weeks 12, 20, 24, 44, and 48 |
100.0; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty |
94.1; 91.7; 92.7; 88.2; 91.7; 90.2 | — |
| SECONDARY Parts 1 and 2: Change From Baseline in Incremental Growth Rate |
-0.6; -0.9; -0.8; -0.6; -2.9; -2.0 | — |
| SECONDARY Parts 1 and 2: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age |
0.5; 0.7; 0.6; 0.2; 0.6; 0.5 | — |
| SECONDARY Part 2: Percentage of Participants With Maintenance of Suppression of GnRHa-stimulated LH (< 4 mlU/mL) |
88.2; 96.2; 93.0; 93.3; 95.7; 94.7 | — |
| SECONDARY Part 2: Percentage of Female Participants With Maintenance of Suppression of Basal Estradiol to < 20 pg/mL |
100.0; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Part 2: Percentage of Male Participants With Maintenance of Suppression of Basal Testosterone to < 30 ng/dL |
100.0; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
Summary
The primary objective of the study is to assess the safety and efficacy of a leuprolide acetate (LA) 45 mg 6-month depot formulation for the treatment of CPP in children who are either naïve to treatment with a gonadotropin-releasing hormone agonist (GnRHa) or who have been previously treated with a GnRHa.
Eligibility Criteria
Inclusion Criteria
- Children with CPP who are naïve to treatment with a gonadotropin-releasing hormone agonist (GnRHa) (females 2 - 8 years of age, or males 2 - 9 years of age) or who have been on standard GnRHa therapy for at least 6 months (females 2 - 10 years of age, or males 2 - 11 years of age).
- No history of clinically significant medical conditions or any other reason that the investigator determines would make the participant an unsuitable candidate to receive study drug.
Data sourced from ClinicalTrials.gov (NCT03695237). 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.