Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty
Condition: Precocious; Leuprolide Acetate; Luteinizing Hormone (LH); Gonadotrophin-releasing Hormone Agonist (GnRHa); Tanner Staging; Depot Formulation; Suppression of LH; Central Precocious Puberty (CPP); Gonadotrophin-releasing Hormone (GnRH); Lupron; GnRH Analog; Pediatrics Central Precocious Puberty
MeSH terms: Puberty, Precocious
Intervention: Leuprolide Acetate 3 Month Depot
Intervention MeSH terms: Leuprolide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Healthy volunteers: No
Keywords: GnRH analog; Luteinizing hormone (LH); Gonadotrophin-releasing hormone agonist(GnRHa); Suppression of LH; Gonadotrophin-releasing hormone (GnRH); CPP; Leuprolide acetate; Central Precocious Puberty; Depot formulation; Lupron; Tanner staging; Pediatrics

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.