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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02452931
• Date of registration: 05/05/2015
• Prospective Registration: Yes
• Primary sponsor: Tolmar Inc.
• Public title: Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty
• Scientific 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
• Date of first enrolment: August 31, 2015
• Target sample size: 64
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02452931
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina, Canada, Chile, Mexico, New Zealand, United States

Contacts

• Name: Peggy Schorr
• Affiliation: orphan reach USA, LLC

Key inclusion & exclusion 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



Age minimum: 2 Years
Age maximum: 9 Years
Gender: All

Health Condition(s) or Problem(s) studied

Precocious Puberty, Central

Intervention(s)

Drug: Leuprolide Acetate 45 mg

Primary Outcome(s)

Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 6 Months. [Time Frame: 6 months]

Secondary Outcome(s)

Changes in Height Velocity (Growth Rate) [Time Frame: Week 4, Week 12, Week 20, Week 24, Week 36, Week 44, and Week 48]

Tanner Scores: Boys and Girls - Pubic Hair [Time Frame: Baseline, Week 12, Week 24, Week 36, and Week 48]

Tanner Scores: Girls - Breast Development (Change From Baseline) [Time Frame: Week 12, Week 24, Week 36, and Week 48]

Tanner Scores: Boys - Development of External Genitalia [Time Frame: Baseline, Week 12, Week 24, Week 36, and Week 48]

Tanner Scores: Boys and Girls - Pubic Hair (Change From Baseline) [Time Frame: Week 12, Week 24, Week 36, and Week 48]

Percent Change From Baseline in Height [Time Frame: Week 4, Week 12, Week 20, Week 24, Week 36, Week 44, and Week 48]

Percentage of Subjects With Suppression of Luteinizing Hormone Measured by Blood Levels. [Time Frame: Week 12, Week 24, Week 36, and Week 48]

Bone Age Ratio to Chronological Age at Time of Measurement [Time Frame: Week 24 and Week 48]

Tanner Scores: Girls - Breast Development [Time Frame: Baseline, Week 12, Week 24, Week 36, and Week 48]

Tanner Scores: Boys - Development of External Genitalia (Change From Baseline) [Time Frame: Week 12, Week 24, Week 36, and Week 48]

Secondary ID(s)

TOL2581A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 20/05/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02452931