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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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier:
NCT01634321
First received: July 3, 2012
Last updated: July 25, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention Phase
Central Precocious Puberty
 Drug: Luphere depot 3.75mg(Leuprolide acetate 3.75mg)
 Phase 4

Study Type: Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Puberty
U.S. FDA Resources

Further study details as provided by Daewoong Pharmaceutical Co. LTD.:

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

Study Start Date: July 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Luphere Drug: Luphere depot 3.75mg(Leuprolide acetate 3.75mg)

  Eligibility

Ages Eligible for Study:   4 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 4~8 years & tanner stage ≥ 2

Exclusion Criteria:

  • Previous treatment with GnRH analog therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01634321

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

No publications provided

Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT01634321     History of Changes
Other Study ID Numbers: DW_LP1M002P
Study First Received: July 3, 2012
Last Updated: July 25, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

ClinicalTrials.gov processed this record on May 23, 2013