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Efficacy and Safety Study of ELIGARD 22.5mg With Prostate Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01511874
First Posted: January 19, 2012
Last Update Posted: September 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
HanAll BioPharma Co., Ltd.
  Purpose
The purpose of this study is to evaluate efficacy and safety of ELIGARD 22.5mg in the treatment of subjects with prostate cancer.

Condition Intervention Phase
Prostate Cancer Drug: ELIGARD 22.5mg Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-comparative, Opened Multicenter Study to Assess the Efficacy and Safety of ELIGARD 22.5mg in the Treatment of Subjects With Prostate Cancer

Resource links provided by NLM:


Further study details as provided by HanAll BioPharma Co., Ltd.:

Primary Outcome Measures:
  • Ratio of subjects whose blood testosterone concentration is maintained below 50ng/dl at 4 weeks after injection of ELIGARD 22.5mg [ Time Frame: 4weeks ]

Secondary Outcome Measures:
  • Ratio of subjects whose blood testosterone concentration is maintained below 50ng/dL until 24weeks [ Time Frame: 24weeks ]
  • Ratio of subjects whose blood testosterone concentration exceed 50ng/dL until 24weeks [ Time Frame: 24weeks ]
  • Change in self assessment scale grade [ Time Frame: 0,4, 8, 12, 24 weeks ]
  • Ratio of subjects whose blood testosterone concentration is below 20ng/dL at 4weeks and 24weeks [ Time Frame: 4, 24 weeks ]
  • Change in ECOG performance status [ Time Frame: 0,4,8,12, 24weeks ]
  • Change in blood prostate-specific antigen [ Time Frame: 0,4,8,12,24 weeks ]
  • Change in QoL_EPIC grade [ Time Frame: 0,12, 24weeks ]
  • Change in penile length [ Time Frame: screening, 12, 24weeks ]
  • Change in testicular volume [ Time Frame: screening, 12, 24weeks ]

Enrollment: 42
Study Start Date: January 2011
Study Completion Date: December 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ELIGRAD 22.5mg
a subcutaneous injection of ELIGARD 22.5mg at 0 and 12weeks
Drug: ELIGARD 22.5mg
a subcutaneous injection of ELIGARD 22.5mg at 0 and 12weeks
Other Name: ELIGARD

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male of 20 years or above
  • Subject with prostate cancer with TNM stage T2~4NxMx
  • Blood testosterone concentration ≥ 100ng/dl
  • Bilirubin ≤ 1.5xULN, transaminase ≤ 2.5xULN
  • WHO ECOG performance status ≤ 2
  • Signed written informed consent

Exclusion Criteria:

  • Hormone-Refractory Prostate cancer
  • Brain metastasis
  • Another primary malignant tumor except for prostate cancer
  • Other conditions which in the opinion of the investigator preclude enrollment into the study
  Contacts and Locations
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): NCT01511874


Locations
Korea, Republic of
Department of Urology,Yonsei University,College of Medicine, Gangnam Severance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
HanAll BioPharma Co., Ltd.
Investigators
Principal Investigator: Byung Ha Chung, Medicine Department of Urology,Yonsei University,College of Medicine, Gangnam Severance Hospital
  More Information

Responsible Party: HanAll BioPharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT01511874     History of Changes
Other Study ID Numbers: fr-HE530-01
First Submitted: January 13, 2012
First Posted: January 19, 2012
Last Update Posted: September 23, 2015
Last Verified: September 2015

Keywords provided by HanAll BioPharma Co., Ltd.:
ELIGARD
Prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents