A clinical trial to determine safety and efficacy of Leuprolide Acetate 11.25mg and 30mg in children with central premature puberty

• Conditions: MedDRA version: 17.1Level: LLTClassification code 10073186Term: Central precocious pubertySystem Organ Class: 100000004860; Therapeutic area: Diseases [C] - Hormonal diseases [C19]; Central Precocious Puberty

• Registration Number: EUCTR2014-004494-16-Outside-EU/EEA
• Lead Sponsor: Abbvie previously known as Abbott

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-03
• Last Update Posted: 8 December 2014

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1. The informed consent form, assent form and any privacy statement (e.g., HIPAA)
must be approved by a local or central Institutional Review Board (IRB) as
required by Regional, State and local regulations. Prior to performing any
trial-related procedures, each subject's parent must review, understand, and sign an
informed consent form. When determined to be appropriate (as specified either by
the IRB and/or State and local regulations), each subject must also sign the assent
form after having had an opportunity to review the form and have its contents
explained and questions answered.
2. Subject completed the Treatment Period of the lead-in study, L-CP07-167, and has
documented LH suppression as evidenced by peak-stimulated LH < 4 mIU/mL at
the Month 6 study visit of the lead-in study. (Note: Subjects who were enrolled
and administered the Day 1 injection in this study and are subsequently found to
not be suppressed at Month 6 of the lead-in study, will no longer be eligible to
receive future injections of investigational product and will be prematurely
discontinued from the study.
3. Demonstrated suppression of the physical signs of puberty at Month 6 of the
lead-in study (defined as regression or no progression of breast development
according to Pubertal staging (in girls) or regression or no progression in testicular
volume and genital staging according to Pubertal staging (in boys).
4. Subject is expected to receive at least 12 months of therapy to treat CPP after study
entry.
5. 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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 72
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Diagnosis of 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 (unresponsive to treatment/expanding)
except hamartoma.
2. Bone age = 14.00 years for girls and = 15.00 years for boys (based on the Month 6
lead-in study, L-CP07-167, radiographic results).
3. Subject has an abnormal laboratory value that suggests a clinically significant
underlying disease or condition that may prevent the subject from entering the
study or subject with the following laboratory abnormalities: Creatinine
> 1.5 mg/dL, ALT and/or AST > 2.0 × ULN, or total bilirubin > 2.0 mg/dL with
AST/ALT elevated above normal limits.
4. Chronic illness requiring treatment that may interfere with growth, i.e., chronic
steroid use, renal failure, moderate to severe scoliosis.
5. Current therapy with medroxyprogesterone acetate.
6. Current therapy with growth hormone.
7. Current therapy with insulin-like growth factor-1 (IGF-1).
8. Current use of an estrogen preparation.
9. 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.
10. Subject has a positive pregnancy test.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified