Trial Review

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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
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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

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
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
NA
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)

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/study/NCT02811471
Trial related presentations / publications
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

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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02811471