Phase 3
N=55
Study of Lupron Depot In The Treatment of Central Precocious Puberty
Puberty, Precocious
Bottom Line
View on ClinicalTrials.gov: NCT00660010 ↗Enrolled (actual)
55
Serious AEs
12.7%
Results posted
Jul 2010
Primary outcome: Primary: Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females) — 81.8; 80.9; 87.8; 82.8 Percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Lupron (leuprolide acetate) (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females) |
81.8; 80.9; 87.8; 82.8; 66.7; 76.9 | — |
| PRIMARY Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Genital Development in Males) |
80.0; 83.3; 83.3; 75.0; 75.0; 66.7 | — |
| SECONDARY Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations |
35.0; 0.8; 1.1; 0.8; 0.6; 0.4 | — |
| SECONDARY Mean Stimulated Estradiol Concentrations in Females |
15.3; 5.0; 6.0; 5.0; 5.0; 5.0 | — |
| SECONDARY Mean Stimulated Testosterone Concentrations in Males |
347.7; 18.0; 14.2; 13.8; 17.3; 24.8 | — |
| SECONDARY Mean Ratio of Bone Age to Chronological Age |
1.5; 1.5; 1.4; 1.3; 1.2; 1.2 | — |
Summary
The purpose of this study is to determine if Lupron (leuprolide acetate) is safe and effective in treating children with Central Precocious Puberty (CPP), and to assess long term effects of leuprolide acetate treatment after therapy is discontinued.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of isosexual central precocious puberty with onset of Tanner scores of Stage II for breast or pubic hair earlier than age 8.0 years in girls or Stage II for pubic hair or genitalia earlier than 9.0 years in boys.
- Confirmation of diagnosis by a pubertal response to a gonadotropin-releasing hormone (GnRH) stimulation test (LH > 10 U/L at baseline).
- Chronological age less than 9.0 years in girls or less than 10.0 years in boys at time of first dosing.
- Bone age advanced at least 1 year beyond the chronological age at entry into the study.
- The condition may be idiopathic or secondary to another lesion. If secondary, therapy of the primary condition will have been undertaken and stabilized.
- No evidence of abnormal pituitary, adrenal, thyroid and gonadal function except for premature secretion of gonadotropins.
Exclusion Criteria
- Irradiation to the central nervous system.
- Prior therapy with medroxyprogesterone acetate and/or with any GnRH analog (including prior treatment with daily subcutaneous and depot formulations of leuprolide acetate).
Data sourced from ClinicalTrials.gov (NCT00660010). 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.