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Analysis of Body Mass Index in Central Precocious Puberty Patients Treated With Leuprolide Acetate

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ClinicalTrials.gov Identifier: NCT02974270
Recruitment Status : Unknown
Verified November 2016 by Cheol Woo Ko, Kyungpook National University.
Recruitment status was:  Recruiting
First Posted : November 28, 2016
Last Update Posted : November 28, 2016
Sponsor:
Information provided by (Responsible Party):
Cheol Woo Ko, Kyungpook National University

Brief Summary:
Analysis of body mass index in Central Precocious Puberty patients treated with leuprolide acetate

Condition or disease Intervention/treatment Phase
Precocious Puberty, Central Drug: Leuprolide Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Analysis of Body Mass Index in Central Precocious Puberty(CPP) Patients Treated With Leuprolide Acetate
Study Start Date : June 2016
Estimated Primary Completion Date : March 2018


Arm Intervention/treatment
Experimental: Leuprolide acetate Drug: Leuprolide



Primary Outcome Measures :
  1. Change from baseline Body Mass Index Standard Deviation Score for Chronological Age at 6 months [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change from baseline Body Mass Index Standard Deviation Score for Chronological Age at 3 months [ Time Frame: 3 months ]


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

Inclusion Criteria:

  1. Child diagnosed with CPP who has a peak-stimulated Lutenizing Hormone(LH) concentration over 5 IU/liter before initiation of therapy
  2. Chronological age(CA) at the appearance of pubertal changes less than 8 years in girls and less than 9 years in boys.
  3. Tanner stage ≥2
  4. Advanced bone age (Bone Age/Chronological Age >1.1)
  5. Able to have the signed written informed consent provided by the patients' parents or legal guardians prior to any study-related procedures

Exclusion Criteria:

  1. Patient with a peripheral precocious puberty: extrapituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroids secretion
  2. Patient with a cerebral tumor requiring a neurosurgery or cerebral irradiation known chronic disease of underlying medical condition
  3. Currently on or planning growth hormone treatment
  4. Previous Gonadotropin-Releasing Hormone agonist treatment
  5. Any patient who in opinion of the investigator should not 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): NCT02974270


Contacts
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Contact: Cheol Woo Ko, MD, PhD 01082453633 cwko@knu.ac.kr

Locations
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Korea, Republic of
Cheol Woo Ko Recruiting
Daegu, Korea, Republic of
Contact: Cheol Woo Ko, MD, PhD         
Sponsors and Collaborators
Kyungpook National University

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Responsible Party: Cheol Woo Ko, MD, PhD, Kyungpook National University
ClinicalTrials.gov Identifier: NCT02974270     History of Changes
Other Study ID Numbers: IISR-2014-100760
First Posted: November 28, 2016    Key Record Dates
Last Update Posted: November 28, 2016
Last Verified: November 2016
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