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

Active, not recruiting

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

• Registration Number: EUCTR2014-004493-42-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: Active
• Sex: All
• Target Recruitment: 80

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 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 has a clinical diagnosis of CPP.
3. Eligible to receive at least 6 months of therapy to treat CPP after study entry.
4. Chronological age at onset of pubertal symptoms less than 8 years old in girls and
less than 9 years old in boys at Day 1.
5. Bone age advanced at least 1 year beyond the chronological age at time of
diagnosis or first GnRHa therapy.
6. 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 naïve to GnRHa treatment:
7. Girls 2-8 years inclusive or Boys 2-9 years inclusive at Day 1
8. Pretreatment pubertal response to leuprolide acetate stimulation (LH = 8 mIU/mL)
at Screening.
9. Breast pubertal staging of at least II in Girls; testicular volume of at least 4cc or
testicular length greater than 2.5 cm in Boys at Screening.
Additional criteria for subjects previously treated with GnRHa:
10. Girls 2-10 years inclusive or Boys 2-11 years inclusive at Day 1.
11. Must have been on standard GnRHa therapy for at least the 6 months prior to
Day 1.
to the end of their previous GnRHa treatment cycle.
12. Should have documented maintenance of LH suppression as evidenced by peak
stimulated LH < 4 mIU/mL at Screening.
Are the trial subjects under 18? yes
Number of subjects for this age range: 84
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. Incomplete precocious puberty (premature thelarche, premature adrenarche).
2. Peripheral precocious puberty: gonadal or adrenal tumors, congenital adrenal
hyperplasia, testotoxicosis in boys, hCG secreting tumor or McCune-Albright
syndrome in girls.
3. Evidence of any abnormal pituitary, hypothalamic, adrenal, thyroid and gonadal
function other than premature secretion of gonadotropins not adequately
controlled.
4. Unstable intracranial tumors (unresponsive to treatment/expanding) except
hamartoma.
5. Previous treatment with GnRHa therapy requiring leuprolide acetate for depot
suspension > 15 mg monthly.
6. Bone age > 13 years for girls and > 14 years for boys.
7. Any other condition interfering with growth, i.e., skeletal dysplasia, cerebral palsy.
8. Chronic illness requiring treatment that may interfere with growth, i.e., chronic
steroid use, renal failure, moderate to severe scoliosis.
9. Diagnosis of short stature, i.e., more than 2.25 SD below the mean height for age
(growth chart measurement).
10. Prior or current therapy with medroxyprogesterone acetate.
11. Prior or current therapy with growth hormone.
12. Subject has an abnormal laboratory value that suggest 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.
13. Subject has a positive pregnancy test.
14. 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.
15. Known hypersensitivity to study medication or its excipients.
16. Subject is a family member of the investigator, sub investigator, or study
coordinator. Family member is defined to include either a child (including step or
foster child), niece, nephew, sibling or cousin.
17. Participation in another drug research within 3 months of randomization into this
study.
18. Prior or current therapy with IGF-1.
19. Use of an estrogen preparation within 2 months prior to Day 1.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy and safety of the 11.25 mg and 30 mg formulations of leuprolide acetate for the treatment of central precocious puberty (CPP) in children who either are naïve to previous treatment with gonadotropin-releasing hormone analog (GnRHa) or who have previously been treated with GnRHa for at least the prior 6 months.;Secondary Objective: To evaluate the pharmacokinetic (PK) profile of leuprolide following<br>intramuscular (IM) administration of the 11.25 and 30 mg depot formulations in a subset of subjects with<br>CPP.;Primary end point(s): Suppression of LH from Month 2 through Month 6 as determined by peak stimulated<br>LH < 4 mIU/mL at Months 2, 3 and 6.;Timepoint(s) of evaluation of this end point: months 2,3 and 6