Back to resultsThe Clinical Trial to Evaluate the Efficacy and Safety of Luphere Depot Inj. 3.75mg(Leuprolide Acetate 3.75mg) in Patients With Precocious Puberty
Primary Purpose
Central Precocious Puberty
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Luphere depot 3.75mg(Leuprolide acetate 3.75mg)
Sponsored by
About this trial
This is an interventional treatment trial for Central Precocious Puberty
Eligibility Criteria
Inclusion Criteria:
- 4~8 years & tanner stage ≥ 2
Exclusion Criteria:
- Previous treatment with GnRH analog therapy
Sites / Locations
- Ajou University medical center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Luphere
Arm Description
Outcomes
Primary Outcome Measures
At 24 weeks, percentage of subjects with suppression of peak-stimulated Luteinizing Hormone (LH) concentrations
Secondary Outcome Measures
Full Information
NCT ID
NCT01634321
First Posted
July 3, 2012
Last Updated
August 1, 2014
Sponsor
Daewoong Pharmaceutical Co. LTD.
1. Study Identification
Unique Protocol Identification Number
NCT01634321
Brief Title
The Clinical Trial to Evaluate the Efficacy and Safety of Luphere Depot Inj. 3.75mg(Leuprolide Acetate 3.75mg) in Patients With Precocious Puberty
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Precocious Puberty
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Luphere
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Luphere depot 3.75mg(Leuprolide acetate 3.75mg)
Primary Outcome Measure Information:
Title
At 24 weeks, percentage of subjects with suppression of peak-stimulated Luteinizing Hormone (LH) concentrations
Time Frame
At 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
4~8 years & tanner stage ≥ 2
Exclusion Criteria:
Previous treatment with GnRH analog therapy
Facility Information:
Facility Name
Ajou University medical center
City
Soo-won
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The Clinical Trial to Evaluate the Efficacy and Safety of Luphere Depot Inj. 3.75mg(Leuprolide Acetate 3.75mg) in Patients With Precocious Puberty
We'll reach out to this number within 24 hrs