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

Precocious Puberty, Central Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02974270
• Other study ID #: IISR-2014-100760
• Status: Recruiting
• Phase: Phase 4
• First received: May 19, 2016
• Last updated: November 22, 2016
• Start date: June 2016

Study information

• Verified date: November 2016
• Source: Kyungpook National University
• Contact: Cheol Woo Ko, MD, PhD
• Phone: 01082453633
• Email: cwko[@]knu.ac.kr
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 9 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Precocious Puberty, Central
• Puberty, Precocious

Intervention

Drug:
• Leuprolide

Locations

Country	Name	City	State
Korea, Republic of	Cheol Woo Ko	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Kyungpook National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Body Mass Index Standard Deviation Score for Chronological Age at 6 months		6 months	No
Secondary	Change from baseline Body Mass Index Standard Deviation Score for Chronological Age at 3 months		3 months	No