Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty
NCT ID: NCT02452931
Last Updated: 2020-06-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
64 participants
INTERVENTIONAL
2015-08-31
2018-09-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Assigned Intervention
Leuprolide acetate 45 mg will be administered as a subcutaneous injection at 6-month intervals for the 12 month study period.
Leuprolide Acetate 45 mg
Subcutaneous injection
Interventions
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Leuprolide Acetate 45 mg
Subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
2 Years
9 Years
ALL
No
Sponsors
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Tolmar Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Peggy Schorr
Role: STUDY_DIRECTOR
orphan reach USA, LLC
Locations
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University of California, San Diego
San Diego, California, United States
Joe DiMaggio Children's Hospital
Hollywood, Florida, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
Nemours Children's Hospital
Orlando, Florida, United States
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, United States
University of Minnesota
Minneapolis, Minnesota, United States
Cincinnati Children's Hospital Medical Center, Endocrine
Cincinnati, Ohio, United States
University of Oklahoma College of Medicine
Tulsa, Oklahoma, United States
Seattle Children's
Seattle, Washington, United States
MultiCare Institute for Research and Innovation
Tacoma, Washington, United States
Hospital de Ninos
Buenos Aires, , Argentina
University of Calgary, Alberta Children's Hospital
Calgary, Alberta, Canada
McGill University Health Centre
Montreal, Quebec, Canada
CHU de Quebec-Universite Laval
Québec, , Canada
Pontificia Universidad Catolica de Chile
Santiago, Santiago Metropolitan, Chile
Instituto de Investigaciones Materno Infantil (IDIMI)
Santiago, Santiago Metropolitan, Chile
Hospital Regional de Antofagasta Leonardo Guzman
Antofagasta, Second Region, Chile
Hospital Unversitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia, A.C.
Durango, , Mexico
The Liggins Institute, University of Auckland
Auckland, , New Zealand
Countries
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References
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Klein KO, Freire A, Gryngarten MG, Kletter GB, Benson M, Miller BS, Dajani TS, Eugster EA, Mauras N. Phase 3 Trial of a Small-volume Subcutaneous 6-Month Duration Leuprolide Acetate Treatment for Central Precocious Puberty. J Clin Endocrinol Metab. 2020 Oct 1;105(10):e3660-71. doi: 10.1210/clinem/dgaa479.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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TOL2581A
Identifier Type: -
Identifier Source: org_study_id
NCT02811471
Identifier Type: -
Identifier Source: nct_alias
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