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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02452931




Registration number
NCT02452931
Ethics application status
Date submitted
5/05/2015
Date registered
25/05/2015
Date last updated
3/07/2019

Titles & IDs
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
Secondary ID [1] 0 0
TOL2581A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Precocious Puberty, Central 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Leuprolide Acetate 45 mg

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


Treatment: Drugs: Leuprolide Acetate 45 mg
Subcutaneous injection

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants with Suppression of Peak-Stimulated Luteinizing Hormone at 6 months. - Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH < 4mIU/mL. Peak stimulated LH refers to the maximum LH concentration measured 30 minutes after a gonadotropin-releasing hormone agonst (GnRHa) stimulation test.
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Percentage of subjects with suppression of luteinizing hormone measured by blood levels.
Timepoint [1] 0 0
Up to 12 months

Eligibility
Key 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
Minimum age
2 Years
Maximum age
9 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Oklahoma
Country [7] 0 0
United States of America
State/province [7] 0 0
Washington
Country [8] 0 0
Argentina
State/province [8] 0 0
Buenos Aires
Country [9] 0 0
Canada
State/province [9] 0 0
Alberta
Country [10] 0 0
Canada
State/province [10] 0 0
Quebec
Country [11] 0 0
Chile
State/province [11] 0 0
Metropolitana
Country [12] 0 0
Chile
State/province [12] 0 0
Second Region
Country [13] 0 0
Mexico
State/province [13] 0 0
Nuevo Leon
Country [14] 0 0
Mexico
State/province [14] 0 0
Durango
Country [15] 0 0
New Zealand
State/province [15] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Tolmar Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study determines the effectiveness of leuprolide acetate 45 mg for injectable suspension
for treatment of children with Central Precocious Puberty.
Trial website
https://clinicaltrials.gov/show/NCT02452931
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peggy Schorr
Address 0 0
orphan reach USA, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications