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

• Sponsor: Kyungpook National University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02974270
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• 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: Jun 1, 2016
• Anticipated Primary Completion Date: Mar 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Leuprolide acetate	Drug: Leuprolide

Outcome Measures

Primary Outcome Measures

1. Change from baseline Body Mass Index Standard Deviation Score for Chronological Age at 6 months [6 months]

Secondary Outcome Measures

1. Change from baseline Body Mass Index Standard Deviation Score for Chronological Age at 3 months [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 9 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cheol Woo Ko	Daegu		Korea, Republic of

Sponsors and Collaborators

• Kyungpook National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cheol Woo Ko, MD, PhD, Kyungpook National University Hospital
• ClinicalTrials.gov Identifier: NCT02974270
• Other Study ID Numbers: IISR-2014-100760
• First Posted: Nov 28, 2016
• Last Update Posted: Nov 28, 2016
• Last Verified: Nov 1, 2016

• Additional relevant MeSH terms: Puberty, Precocious; Leuprolide

Study Results

No Results Posted as of Nov 28, 2016