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

• Register: ClinicalTrials.gov
• Last refreshed on: 4 July 2016
• Main ID: NCT02811471
• Date of registration: 21/06/2016
• Prospective Registration: No
• Primary sponsor: Nemours Children's Clinic
• Public title: Pharmacokinetic 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—Part A and B
• Date of first enrolment: June 2016
• Target sample size: 5
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02811471
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Karen Walker, RN

Key inclusion & exclusion criteria

Inclusion Criteria:

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

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

3. Pubertal-type LH response following an abbreviated GnRHa stimulation test before
treatment initiation > 5 mIU/mL

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

5. Willing and able to participate in the study

6. Difference between bone age (Greulich and Pyle method) and chronological age = 1 year

7. Signed Institutional Review Board/Independent Ethics Committee (IRB/IEC)-approved
informed consent form (ICF) by one or both parents (per IRB/IEC requirements), by the
custodial parent or by the legal guardian(s) (if required)

8. Signed Assent by subjects as per IRB/IEC requirements

Exclusion Criteria:

1. Gonadotropin-independent (peripheral) precocious puberty: extra pituitary secretion
of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroid secretion

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 requiring
neurosurgery or cerebral irradiation. Subjects with hamartomas not requiring surgery
are eligible.

5. Any other condition, chronic illness or treatment that, in the opinion of the
Investigator, may interfere with growth or other study endpoints (eg, chronic steroid
use [except mild topical steroids) renal failure, diabetes, moderate to severe
scoliosis, previously treated intracranial tumor).

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

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

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

9. Positive urine pregnancy test

10. Known hypersensitivity to GnRH or related compounds

11. 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

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 in
prior clinical studies before the baseline visit (Day 0)

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

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



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

Health Condition(s) or Problem(s) studied

Central Precocious Puberty

Intervention(s)

Drug: Leuprolide

Primary Outcome(s)

Primary Efficacy Endpoint [Time Frame: 6 months]

Secondary ID(s)

611

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Tolmar Inc.