COMPLETEDPHASE4

The Clinical Trial to Evaluate the Efficacy and Safety of Luphere Depot Inj. 3.75mg(Leuprolide Acetate 3.75mg) in Patients With Precocious Puberty

The Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of Luphere Depot Inj. 3.75mg(Leuprolide Acetate 3.75mg) in Patients With Precocious Puberty; A Single, Open, Multi-center, Prospective Study

NCT01634321•Daewoong Pharmaceutical Co. LTD.

View on ClinicalTrials.gov

Summary

The purpose of this Clinical Trial was to Evaluate the Efficacy and Safety of Luphere Depot Inj. 3.75mg(Leuprolide acetate 3.75mg) in patients with precocious puberty.

Eligibility

Age

4 - 9 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•4\~8 years \& tanner stage ≥ 2

Exclusion Criteria

•Previous treatment with GnRH analog therapy

Locations (1)

Ajou University medical center

Soo-won, South Korea

Key Dates

Start Date

July 1, 2011

Primary Completion Date

August 1, 2012

Completion Date

August 1, 2012

Last Updated

August 4, 2014

Enrollment

63

ACTUAL participants

Conditions

Central Precocious Puberty

Interventions

Luphere depot 3.75mg(Leuprolide acetate 3.75mg)

DRUG

A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Debio 4326 in Pediatric Participants With Central Precocious Puberty (LIBELULA™ Clinical Trial)

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COMPLETEDPHASE3

A Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Paediatric Participants With Central Precocious Puberty.

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COMPLETED

Diagnostic Power of Basal LH Compared to Peak LH After Stimulus Test in the Diagnosis of Central Precocious Puberty

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 4, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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