Phase 3
N=72
Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty
Precocious · Leuprolide Acetate · Luteinizing Hormone (LH) · Gonadotrophin-releasing Hormone Agonist (GnRHa) · Tanner Staging
Bottom Line
View on ClinicalTrials.gov: NCT00667446 ↗Enrolled (actual)
72
Serious AEs
1.4%
Results posted
Dec 2013
Primary outcome: Primary: Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone — 96.9; 100.0; 93.8; 100.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Leuprolide Acetate 3 Month Depot (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone |
96.9; 100.0; 93.8; 100.0; 90.3; 96.9 | — |
| SECONDARY Percentage of Female Participants With Suppression of Basal Estradiol (Assay 1) |
96.4; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Percentage of Female Participants With Suppression of Basal Estradiol (Assay 2) |
100.0; 83.3; 61.5; 40.0; 45.0; 60.0 | — |
| SECONDARY Percentage of Male Participants With Suppression of Basal Testosterone |
100.0; 100.0; 100.0; 100.0; 100.0; 80.0 | — |
| SECONDARY Mean Peak-stimulated Luteinizing Hormone Concentration by Visit |
21.89; 10.16; 2.00; 1.49; 2.22; 1.62 | — |
| SECONDARY Percentage of Female Participants With Suppression of the Physical Signs of Puberty (Breast Development) |
90.3; 83.9; 86.2; 87.1; 90.3; 80.0 | — |
| SECONDARY Percentage of Male Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development) |
50.0; 40.0; 50.0; 60.0; 50.0; 60.0 | — |
| SECONDARY Change From Baseline in Growth Rate |
7.2; 7.53; -1.67; -1.65; -1.66; -2.04 | — |
| SECONDARY Ratio of Change From Baseline in Bone Age/Change From Baseline in Chronological Age |
0.51; 1.02; 0.52; 0.62; 0.53; 0.72 | — |
Summary
The purpose of this extension study is to determine if leuprolide acetate (11.25 mg and 30 mg) is safe in treating children with Central Precocious Puberty over a longer period of time (36 months).
Eligibility Criteria
Inclusion Criteria
- Subject completed the Treatment Period of the lead-in study, L-CP07-167 (NCT00635817), and has documented luteinizing hormone suppression as evidenced by peak-stimulated luteinizing hormone <4 mIU/mL at the Month 6 study visit of the lead-in study.
- Demonstrated suppression of the physical signs of puberty at Month 6 of the lead-in study.
- Subject is expected to receive at least 12 months of therapy to treat Central Precocious Puberty after study entry.
- 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.
Exclusion Criteria
- Incomplete precocious puberty, peripheral precocious puberty or evidence of any abnormal pituitary, hypothalamic, adrenal, thyroid and gonadal function (other than premature secretion of gonadotropins) not adequately controlled, unstable intracranial tumors except hamartoma.
- Bone age ≥14 years for girls and ≥15 years for boys (based on the Month 6 lead in study, L-CP07-167, radiographic results).
- Has an abnormal laboratory value suggesting a clinically significant underlying disease or condition.
- Chronic illness requiring treatment that may interfere with growth, ie, chronic steroid use, renal failure, moderate to severe scoliosis.
- Current therapy with medroxyprogesterone acetate.
- Current therapy with growth hormone.
- Current therapy with insulin-like growth factor-1 (IGF-1).
- Current use of an estrogen preparation.
- Any concomitant medical condition that, in the opinion of the investigator, may expose a subject to an unacceptable level of safety risk or that affects subject compliance.
- Subject has a positive pregnancy test.
Data sourced from ClinicalTrials.gov (NCT00667446). 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.