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

Tolmar Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Precocious Puberty, Central

Treatments: Drug: Leuprolide Acetate 45 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02452931

TOL2581A

Details and patient eligibility

About

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

Full description

Leuprolide acetate is a GnRH agonist that inhibits pituitary gonadotropin secretion by binding to the GnRH receptors and blocking downstream hormone synthesis. The steady decrease in hormone synthesis (LH and FSH) leads to a suppression of testicular and ovarian steroidogenesis. In children with CPP, this steady decrease in hormone synthesis disrupts the progression of puberty.

Enrollment: 64 patients

Sex: All

Ages: 2 to 9 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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64 participants in 1 patient group

Assigned Intervention

Experimental group

Description:

Leuprolide acetate 45 mg will be administered as a subcutaneous injection at 6-month intervals for the 12 month study period.

Treatment:

Drug: Leuprolide Acetate 45 mg