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

Information source: Tolmar Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Precocious Puberty, Central

Intervention: Leuprolide Acetate 45 mg (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Tolmar Inc.

Official(s) and/or principal investigator(s):
Peggy Schorr, Study Director, Affiliation: orphan reach USA, LLC

Overall contact:
Peggy Schorr, Phone: 856-229-0505, Email: pschorr@orphan-reach.com


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

Clinical Details

Official title: An Open-label, Single Arm, Multicenter Study on the Efficacy, Safety, and Pharmacokinetics of Leuprolide Acetate 45 mg for Injectable Suspension Controlled Release in Subjects With Central (Gonadotropin-Dependent) Precocious Puberty

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of Participants with Suppression of Peak-Stimulated Luteinizing Hormone at 6 months.

Secondary outcome: Percentage of subjects with suppression of luteinizing hormone measured by blood levels.

Detailed 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.


Minimum age: 2 Years. Maximum age: 9 Years. Gender(s): Both.


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

Locations and Contacts

Peggy Schorr, Phone: 856-229-0505, Email: pschorr@orphan-reach.com

Pediatric Endocrinology of Phoenix, Phoenix, Arizona 85053, United States; Recruiting
Fran Hoekstra, RN, Phone: 623-748-4700, Email: fran@pedendophoenix.com
Tala Dajani, MD, Principal Investigator
Additional Information

Starting date: May 2015
Last updated: June 1, 2015

Page last updated: August 23, 2015

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