Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty

• Status: Completed
• Trial end date: 2018-09-05
• Target enrollment: 0
• Participant gender: All

Summary

This study determines the effectiveness of leuprolide acetate 45 mg for injectable suspension for treatment of children with Central Precocious Puberty.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tolmar Inc.
• Treatments: Leuprolide

Criteria

Inclusion Criteria:

• Females age 2 to 8 years (inclusive) or males age 2 to 9 years (inclusive)

• Confirmed diagnosis of CPP within 12 months of Baseline Visit (Day 0) but have not received prior GnRH agonist treatment for CPP

• Pubertal-type LH response following an abbreviated GnRHa stimulation test before treatment initiation

• Clinical evidence of puberty, defined as Tanner stage ≥ 2 for breast development in females or testicular volume ≥ 4 mL in males

• Difference between bone age (Greulich and Pyle method) and chronological age ≥ 1 year

Exclusion Criteria:

• Gonadotropin-independent (peripheral) precocious puberty

• Prior or current GnRH treatment for CPP

• Prior or current therapy with medroxyprogesterone acetate, growth hormone or insulin-like growth factor-1 (IGF-1)

• Diagnosis of short stature (ie, 2.25 standard deviations (SD) below the mean height for age)

• Known history of seizures, epilepsy, and/or central nervous system disorders that may be associated with seizures or convulsions

• Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study