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

Kyungpook National University

Status and phase: Unknown; Phase 4

Conditions: Precocious Puberty, Central

Treatments: Drug: Leuprolide

Study type: Interventional

Funder types: Other

Identifiers

NCT02974270

IISR-2014-100760

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: Under 9 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Leuprolide acetate

Experimental group

Treatment:

Drug: Leuprolide