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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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.
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
Week 12, Week 24, Week 36, and Week 48
Secondary outcome [2] 0 0
Changes in Height Velocity (Growth Rate)
Timepoint [2] 0 0
Week 4, Week 12, Week 20, Week 24, Week 36, Week 44, and Week 48
Secondary outcome [3] 0 0
Bone Age Ratio to Chronological Age at Time of Measurement
Timepoint [3] 0 0
Week 24 and Week 48
Secondary outcome [4] 0 0
Percent Change From Baseline in Height
Timepoint [4] 0 0
Week 4, Week 12, Week 20, Week 24, Week 36, Week 44, and Week 48
Secondary outcome [5] 0 0
Tanner Scores: Boys - Development of External Genitalia
Timepoint [5] 0 0
Baseline, Week 12, Week 24, Week 36, and Week 48
Secondary outcome [6] 0 0
Tanner Scores: Boys - Development of External Genitalia (Change From Baseline)
Timepoint [6] 0 0
Week 12, Week 24, Week 36, and Week 48
Secondary outcome [7] 0 0
Tanner Scores: Boys and Girls - Pubic Hair
Timepoint [7] 0 0
Baseline, Week 12, Week 24, Week 36, and Week 48
Secondary outcome [8] 0 0
Tanner Scores: Boys and Girls - Pubic Hair (Change From Baseline)
Timepoint [8] 0 0
Week 12, Week 24, Week 36, and Week 48
Secondary outcome [9] 0 0
Tanner Scores: Girls - Breast Development
Timepoint [9] 0 0
Baseline, Week 12, Week 24, Week 36, and Week 48
Secondary outcome [10] 0 0
Tanner Scores: Girls - Breast Development (Change From Baseline)
Timepoint [10] 0 0
Week 12, Week 24, Week 36, and Week 48

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
Sex
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
Not applicable
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
31/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/09/2018
Sample size
Target
Accrual to date
Final
64
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol https://cdn.clinicaltrials.gov/large-docs/31/NCT02452931/Prot_000.pdf
Statistical analysis plan https://cdn.clinicaltrials.gov/large-docs/31/NCT02452931/SAP_001.pdf
Study protocol https://cdn.clinicaltrials.gov/large-docs/31/NCT02452931/Prot_000.pdf
Statistical analysis plan https://cdn.clinicaltrials.gov/large-docs/31/NCT02452931/SAP_001.pdf
Study protocol https://cdn.clinicaltrials.gov/large-docs/31/NCT02452931/Prot_000.pdf
Statistical analysis plan https://cdn.clinicaltrials.gov/large-docs/31/NCT02452931/SAP_001.pdf
Study protocol https://cdn.clinicaltrials.gov/large-docs/31/NCT02452931/Prot_000.pdf
Statistical analysis plan https://cdn.clinicaltrials.gov/large-docs/31/NCT02452931/SAP_001.pdf
Study protocol https://cdn.clinicaltrials.gov/large-docs/31/NCT02452931/Prot_000.pdf
Statistical analysis plan https://cdn.clinicaltrials.gov/large-docs/31/NCT02452931/SAP_001.pdf



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02452931