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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02811471
Registration number
NCT02811471
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
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
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
NA
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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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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/study/NCT02811471
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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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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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02811471
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