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

Phase 4

Completed

• Conditions: Central Precocious Puberty
• Interventions: Drug: Luphere depot 3.75mg(Leuprolide acetate 3.75mg)

• Registration Number: NCT01634321
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2012-07-03
• Study First Submitted QC: 2012-07-05
• Study First Posted: 2012-07-06
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-01
• Last Update Posted: 2014-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• 4~8 years & tanner stage ≥ 2

Exclusion Criteria

• Previous treatment with GnRH analog therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Luphere	Luphere depot 3.75mg(Leuprolide acetate 3.75mg)	-

Primary Outcome Measures

Name	Time	Method
At 24 weeks, percentage of subjects with suppression of peak-stimulated Luteinizing Hormone (LH) concentrations	At 24 weeks

Trial Locations

Locations (1)

Ajou University medical center; 🇰🇷 Soo-won, Korea, Republic of

Ajou University medical center

🇰🇷Soo-won, Korea, Republic of