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

NCT ID: NCT02974270

Last Updated: 2016-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Brief Summary

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

Detailed Description

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Conditions

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Precocious Puberty, Central

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Leuprolide acetate

Group Type EXPERIMENTAL

Leuprolide

Intervention Type DRUG

Interventions

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Leuprolide

Intervention Type DRUG

Eligibility Criteria

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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
Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyungpook National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Cheol Woo Ko

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cheol Woo Ko

Daegu, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Cheol Woo Ko, MD, PhD

Role: CONTACT

Phone: 01082453633

Email: [email protected]

Facility Contacts

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Cheol Woo Ko, MD, PhD

Role: primary

Other Identifiers

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IISR-2014-100760

Identifier Type: -

Identifier Source: org_study_id