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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02452931
Registration number
NCT02452931
Ethics application status
Date submitted
5/05/2015
Date registered
25/05/2015
Date last updated
2/06/2020
Titles & IDs
Public title
Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty
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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
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Secondary ID [1]
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TOL2581A
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Precocious Puberty, Central
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Condition category
Condition code
Metabolic and Endocrine
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Other endocrine disorders
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 6 Months.
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Assessment method [1]
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Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH <4 IU/L. Peak stimulated LH refers to the maximum LH concentration measured 30 minutes after a gonadotropin-releasing hormone agonst (GnRHa) stimulation test.
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Timepoint [1]
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6 months
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Secondary outcome [1]
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Percentage of Subjects With Suppression of Luteinizing Hormone Measured by Blood Levels.
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Assessment method [1]
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Percentage of subjects with suppressed serum LH concentrations(<4 IU/L) 30 minutes post GnRHa stimulation test at all assessed timepoints.
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Timepoint [1]
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Week 12, Week 24, Week 36, and Week 48
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Secondary outcome [2]
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Changes in Height Velocity (Growth Rate)
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Assessment method [2]
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Changes in height velocity (growth rate) at all study timepoints after Screening to end of study. Growth velocity is defined for each visit as change from baseline / [(number of weeks since baseline)/52]. Week 48: Change from Week 24 growth velocity is defined as change from week 24 to week 48 / [(number of weeks since week 24)/52].
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Timepoint [2]
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Week 4, Week 12, Week 20, Week 24, Week 36, Week 44, and Week 48
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Secondary outcome [3]
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Bone Age Ratio to Chronological Age at Time of Measurement
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Assessment method [3]
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Bone Age Ratio to Chronological Age at Time of Measurement is bone age/age at bone age assessment.
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Timepoint [3]
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Week 24 and Week 48
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Secondary outcome [4]
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Percent Change From Baseline in Height
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Assessment method [4]
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The percent change from baseline in height at each available post-baseline measurement. Percent change is defined as (((change from Baseline)/(Baseline)) x 100).
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Timepoint [4]
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Week 4, Week 12, Week 20, Week 24, Week 36, Week 44, and Week 48
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Secondary outcome [5]
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Tanner Scores: Boys - Development of External Genitalia
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Assessment method [5]
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Sexual development (physical signs) in puberty were assessed by Tanner staging, a system developed by Marshall and Tanner to categorize pubertal maturation. Tanner stages are commonly used to categorize pubertal maturation in terms of sequence, timing and tempo. Tanner Stages: the minimum is Stage 1 = pre-pubertal physical characteristics and the maximum is Stage 5 = fully matured (adult) physical characteristics.
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Timepoint [5]
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Baseline, Week 12, Week 24, Week 36, and Week 48
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Secondary outcome [6]
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Tanner Scores: Boys - Development of External Genitalia (Change From Baseline)
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Assessment method [6]
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Sexual development (physical signs) in puberty were assessed by Tanner staging, a system developed by Marshall and Tanner to categorize pubertal maturation. Tanner stages are commonly used to categorize pubertal maturation in terms of sequence, timing and tempo. Tanner Stages: the minimum is Stage 1 = pre-pubertal physical characteristics and the maximum is Stage 5 = fully matured (adult) physical characteristics.
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Timepoint [6]
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Week 12, Week 24, Week 36, and Week 48
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Secondary outcome [7]
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Tanner Scores: Boys and Girls - Pubic Hair
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Assessment method [7]
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Sexual development (physical signs) in puberty were assessed by Tanner staging, a system developed by Marshall and Tanner to categorize pubertal maturation. Tanner stages are commonly used to categorize pubertal maturation in terms of sequence, timing and tempo. Tanner Stages: the minimum is Stage 1 = pre-pubertal physical characteristics and the maximum is Stage 5 = fully matured (adult) physical characteristics.
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Timepoint [7]
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Baseline, Week 12, Week 24, Week 36, and Week 48
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Secondary outcome [8]
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Tanner Scores: Boys and Girls - Pubic Hair (Change From Baseline)
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Assessment method [8]
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Sexual development (physical signs) in puberty were assessed by Tanner staging, a system developed by Marshall and Tanner to categorize pubertal maturation. Tanner stages are commonly used to categorize pubertal maturation in terms of sequence, timing and tempo. Tanner Stages: the minimum is Stage 1 = pre-pubertal physical characteristics and the maximum is Stage 5 = fully matured (adult) physical characteristics.
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Timepoint [8]
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Week 12, Week 24, Week 36, and Week 48
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Secondary outcome [9]
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Tanner Scores: Girls - Breast Development
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Assessment method [9]
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Sexual development (physical signs) in puberty were assessed by Tanner staging, a system developed by Marshall and Tanner to categorize pubertal maturation. Tanner stages are commonly used to categorize pubertal maturation in terms of sequence, timing and tempo. Tanner Stages: the minimum is Stage 1 = pre-pubertal physical characteristics and the maximum is Stage 5 = fully matured (adult) physical characteristics.
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Timepoint [9]
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Baseline, Week 12, Week 24, Week 36, and Week 48
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Secondary outcome [10]
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Tanner Scores: Girls - Breast Development (Change From Baseline)
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Assessment method [10]
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Sexual development (physical signs) in puberty were assessed by Tanner staging, a system developed by Marshall and Tanner to categorize pubertal maturation. Tanner stages are commonly used to categorize pubertal maturation in terms of sequence, timing and tempo. Tanner Stages: the minimum is Stage 1 = pre-pubertal physical characteristics and the maximum is Stage 5 = fully matured (adult) physical characteristics.
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Timepoint [10]
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Week 12, Week 24, Week 36, and Week 48
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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
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Minimum age
2
Years
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Maximum age
9
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
31/08/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
5/09/2018
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Sample size
Target
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Accrual to date
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Final
64
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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Florida
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United States of America
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Indiana
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United States of America
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Minnesota
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United States of America
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Ohio
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United States of America
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Oklahoma
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United States of America
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Washington
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Argentina
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Buenos Aires
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Canada
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Alberta
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Canada
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State/province [10]
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Quebec
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Chile
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Metropolitana
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Chile
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Second Region
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Mexico
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State/province [13]
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Nuevo Leon
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Mexico
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State/province [14]
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Durango
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New Zealand
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State/province [15]
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Auckland
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Tolmar Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study determines the effectiveness of leuprolide acetate 45 mg for injectable suspension
for treatment of children with Central Precocious Puberty.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02452931
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Peggy Schorr
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Address
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orphan reach USA, LLC
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02452931
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