Efficacy and Safety of Leuprolide Acetate 45 mg in Subjects With Central Precocious Puberty

Inclusion Criteria:

1. Pubertal-type LH response following an abbreviated GnRH stimulation test beforetreatment initiation > 5 IU/L

2. A subject manifested with central precocious puberty according to the followingcriteria Age : Boy (4 years of age or older ~ under 9 years of age) Girl (4 years ofage or older ~ under 8 years of age) Tanner Stage : Level 2 or higher

3. Based on baseline visit (Day 0), those under the age of 10 for boys and those underthe age of 9 for girls

4. Confirmed diagnosis of CPP within 12 months of Baseline Visit (Day 0) but have notreceived prior GnRH agonist treatment for CPP

5. Children with a body weight of more than 20 kg at screening

6. Children have a bone age that is ≥1 year older than their chronological age atscreening

7. A signed written consent form by a legal representative who has been informed aboutthis study

Exclusion Criteria:

1. Gonadotropin-independent (peripheral) precocious puberty: extra pituitary secretionof gonadotropins or gonadotropin-independent gonadal or adrenal sex steroidsecretion

2. Prior or current GnRH treatment for CPP

3. Non-progressing isolated premature thelarche

4. Presence of an unstable intracranial tumor or an intracranial tumor requiringneurosurgery or cerebral irradiation. Subjects with hamartomas not requiring surgeryare eligible.

5. Prior (within 12 weeks of Screening) use of medications

• Hormonal agonists (Estrogen, Progesterone, FSH, LH, Testosterone etc.)

• Hormonal antagonists (Anti-Estrogen agents, Anti-Androgen agents)

• Steroid use (except for mild topical steroids, oral steroids are allowed within 30 days)

• Herbal Medicines

6. Prior or current therapy with growth hormone

7. Major medical or psychiatric illness that could interfere with study visits

8. Diagnosis of short stature (i.e. 2 standard deviations (SD) below the mean heightfor age or 3rd percentile for age)

9. Pregnant or likely pregnant women (Positive urine pregnancy test), nursing women

10. Known hypersensitivity to GnRH or related compounds

11. Any other medical condition or serious intercurrent illness that, in the opinion ofthe investigator, may make it undesirable for the subject to participate in thestudy

12. Any other condition(s) which could significantly interfere with Protocol compliance

13. Treatment with an investigational product within 5 half-lives of that product inprior clinical studies before the baseline visit (Day 0)

14. Known history of seizures, epilepsy, and/or central nervous system disorders thatmay be associated with seizures or convulsions

15. Prior (within 6 months of Baseline (Day 0)) or current use of medications that, perinvestigator opinion, have been associated with seizures or convulsions