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Pharmacokinetic Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty

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ClinicalTrials.gov Identifier: NCT02452931
Recruitment Status : Completed
First Posted : May 25, 2015
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Tolmar Inc.

Brief Summary:
This study determines the effectiveness of leuprolide acetate 45 mg for injectable suspension for treatment of children with Central Precocious Puberty.

Condition or disease Intervention/treatment Phase
Precocious Puberty, Central Drug: Leuprolide Acetate 45 mg Phase 3

Detailed Description:
Leuprolide acetate is a GnRH agonist that inhibits pituitary gonadotropin secretion by binding to the GnRH receptors and blocking downstream hormone synthesis. The steady decrease in hormone synthesis (LH and FSH) leads to a suppression of testicular and ovarian steroidogenesis. In children with CPP, this steady decrease in hormone synthesis disrupts the progression of puberty.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : August 31, 2015
Actual Primary Completion Date : September 5, 2018
Actual Study Completion Date : September 5, 2018


Arm Intervention/treatment
Experimental: Assigned Intervention
Leuprolide acetate 45 mg will be administered as a subcutaneous injection at 6-month intervals for the 12 month study period.
Drug: Leuprolide Acetate 45 mg
Subcutaneous injection




Primary Outcome Measures :
  1. Percentage of Participants with Suppression of Peak-Stimulated Luteinizing Hormone at 6 months. [ Time Frame: 6 months ]
    Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH < 4mIU/mL. Peak stimulated LH refers to the maximum LH concentration measured 30 minutes after a gonadotropin-releasing hormone agonst (GnRHa) stimulation test.


Secondary Outcome Measures :
  1. Percentage of subjects with suppression of luteinizing hormone measured by blood levels. [ Time Frame: Up to 12 months ]


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Ages Eligible for Study:   2 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02452931


Locations
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United States, California
University of California, San Diego
San Diego, California, United States, 92123
United States, Florida
Joe DiMaggio Children's Hospital
Hollywood, Florida, United States, 33021
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Nemours Children's Hospital
Orlando, Florida, United States, 32827
United States, Indiana
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, United States, 46202
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55414
United States, Ohio
Cincinnati Children's Hospital Medical Center, Endocrine
Cincinnati, Ohio, United States, 45229
United States, Oklahoma
University of Oklahoma College of Medicine
Tulsa, Oklahoma, United States, 74135
United States, Washington
Seattle Children's
Seattle, Washington, United States, 98105
MultiCare Institute for Research and Innovation
Tacoma, Washington, United States, 98405
Argentina
Hospital de Ninos
Buenos Aires, Argentina, C1425EFD
Canada, Alberta
University of Calgary, Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
Canada, Quebec
McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1
Canada
CHU de Quebec-Universite Laval
Quebec, Canada, G1V 4G2
Chile
Pontificia Universidad Catolica de Chile
Santiago, Metropolitana, Chile, 8330074
Instituto de Investigaciones Materno Infantil (IDIMI)
Santiago, Metropolitana, Chile, 8360160
Hospital Regional de Antofagasta Leonardo Guzman
Antofagasta, Second Region, Chile, 1270001
Mexico
Hospital Unversitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo Leon, Mexico, 64460
Instituto de Investigaciones Aplicadas a la Neurociencia, A.C.
Durango, Mexico, 34000
New Zealand
The Liggins Institute, University of Auckland
Auckland, New Zealand, 1023
Sponsors and Collaborators
Tolmar Inc.
Investigators
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Study Director: Peggy Schorr orphan reach USA, LLC

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Responsible Party: Tolmar Inc.
ClinicalTrials.gov Identifier: NCT02452931     History of Changes
Obsolete Identifiers: NCT02811471
Other Study ID Numbers: TOL2581A
First Posted: May 25, 2015    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Puberty, Precocious
Gonadal Disorders
Endocrine System Diseases
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents