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

Central Precocious Puberty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01634321
• Other study ID #: DW_LP1M002P
• Status: Completed
• Phase: Phase 4
• First received: July 3, 2012
• Last updated: August 1, 2014
• Start date: July 2011
• Est. completion date: August 2012

Study information

• Verified date: August 2014
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 9 Years

Eligibility

Inclusion Criteria:

• 4~8 years & tanner stage = 2

Exclusion Criteria:

• Previous treatment with GnRH analog therapy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Central Precocious Puberty
• Puberty, Precocious

Intervention

Drug:
• Luphere depot 3.75mg(Leuprolide acetate 3.75mg)

Locations

Country	Name	City	State
Korea, Republic of	Ajou University medical center	Soo-won

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	At 24 weeks, percentage of subjects with suppression of peak-stimulated Luteinizing Hormone (LH) concentrations		At 24 weeks