Phase 3
N=84
A Study of Leuprolide 11.25 mg and 30 mg Administered Every 3 Months to Treat Central Precocious Puberty
Puberty, Precocious
Bottom Line
View on ClinicalTrials.gov: NCT00635817 ↗Enrolled (actual)
84
Serious AEs
2.4%
Results posted
Feb 2011
Primary outcome: Primary: Percentage of Participants With Suppression of Peak Stimulated Luteinizing Hormone (<4 mIU/mL) From Month 2 Through Month 6 — 76.2; 80.7; 90.5; 100 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Leuprolide acetate 11.25 mg (Drug); Leuprolide acetate 30 mg (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Suppression of Peak Stimulated Luteinizing Hormone (<4 mIU/mL) From Month 2 Through Month 6 |
76.2; 80.7; 90.5; 100 | — |
| SECONDARY Percentage of Participants With Suppression of Basal Estradiol <20 pg/mL by Visit |
100; 100; 100; 100; 94.7; 100 | — |
| SECONDARY Percentage of Participants With Suppression of Testosterone in <30 ng/dL by Visit |
50.0; 100; 100; 100; 50.0; 100 | — |
| SECONDARY Peak-stimulated Luteinizing Hormone Concentration by Visit |
45.9; 1.8; 23.5; 1.7; 4.4; 1.7 | — |
| SECONDARY Percentage of Participants With Suppression of the Physical Signs of Puberty (Breast Development) at Month 6 |
92.9; 88.9; 82.4; 82.4 | — |
| SECONDARY Percentage of Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development) at Month 6 |
100; 0; 50; 33.3 | — |
| SECONDARY Change From Baseline in Incremental Growth Rate (cm/Year) at Month 6 |
7.25; 6.58; 7.83; 6.05; -2.51; -0.98 | 0.099 |
| SECONDARY Ratio of Change From Baseline in Bone Age/Change From Baseline in Chronological Age at Month 6 |
0.59; 0.50; 1.00; 1.07 | 0.008 sig |
Summary
The purpose of this study is to determine if 11.25 and 30 mg formulations of leuprolide are effective in treating children with Central Precocious Puberty (CPP).
Eligibility Criteria
Inclusion Criteria
- Subject has a clinical diagnosis of CPP.
- Eligible to receive at least 6 mo of therapy to treat CPP after study entry.
- Bone age advanced at least 1 year beyond the chronological age at time of diagnosis or first treatment.
- In general good health with no uncontrolled, clinically significant disease which would interfere with bone maturation or mask the objectives of this protocol as assessed by the investigator.
Additional criteria for subjects who have not had previous treatment:
- Girls 2-8 years inclusive or Boys 2-9 years inclusive at Day 1.
- Has pretreatment pubertal response to leuprolide acetate stimulation (luteinizing hormone ≥8 mIU/mL) at Screening.
- Breast pubertal staging of at least 2 in girls; testicular volume of at least 4 cc or testicular length greater than 2.5 cm in boys at Screening.
Additional criteria for subjects previously treated:
- Girls 2-10 years inclusive or boys 2-11 years inclusive at Day 1.
- Must have been on standard gonadotropin releasing hormone analog therapy for at least the 6 mo prior to Day 1.
- Has documented maintenance of luteinizing hormone suppression as evidenced by peak stimulated level 15 mg monthly.
- Bone age >13 years for girls and >14 years for boys.
- Any other condition interfering with growth, ie, skeletal dysplasia, cerebral palsy.
- Chronic illness requiring treatment that may interfere with growth, ie, chronic steroid use, renal failure, moderate to severe scoliosis.
- Diagnosis of short stature, ie more than 2.25 standard deviations below the mean height for age (growth chart measurement).
- Prior or current therapy with medroxyprogesterone acetate or growth hormone.
- Has an abnormal laboratory value suggesting a clinically significant underlying disease .
- Creatinine >1.5 mg/dL, alanine aminotransferase and/or aspartate aminotransferase >2.0 x upper limit of normal, or total bilirubin >2.0 mg/dL with aspartate aminotransferase/alanine aminotransferase elevated above normal limits.
- Positive pregnancy test.
- Known hypersensitivity to study medication or its excipients.
- Participation in another drug research within 3 mo of enrollment into this study.
- Prior or current therapy with insulin-like growth factor-1.
- Use of an estrogen preparation within 2 mo prior to Day 1.
Data sourced from ClinicalTrials.gov (NCT00635817). 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.