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

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ClinicalTrials.gov Identifier: NCT01634321
Recruitment Status : Completed
First Posted : July 6, 2012
Last Update Posted : August 4, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Central Precocious Puberty Drug: Luphere depot 3.75mg(Leuprolide acetate 3.75mg) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2011
Primary Completion Date : August 2012
Study Completion Date : August 2012


Arm Intervention/treatment
Experimental: Luphere Drug: Luphere depot 3.75mg(Leuprolide acetate 3.75mg)



Primary Outcome Measures :
  1. At 24 weeks, percentage of subjects with suppression of peak-stimulated Luteinizing Hormone (LH) concentrations [ Time Frame: At 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 4~8 years & tanner stage ≥ 2

Exclusion Criteria:

  • Previous treatment with GnRH analog therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01634321


Locations
Korea, Republic of
Ajou University medical center
Soo-won, Korea, Republic of
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.

Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT01634321     History of Changes
Other Study ID Numbers: DW_LP1M002P
First Posted: July 6, 2012    Key Record Dates
Last Update Posted: August 4, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Puberty, Precocious
Gonadal Disorders
Endocrine System Diseases
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents