Efficacy and Safety Study of ELIGARD 22.5mg With Prostate Cancer

Non-comparative, Opened Multicenter Study to Assess the Efficacy and Safety of ELIGARD 22.5mg in the Treatment of Subjects With Prostate Cancer

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01511874

Enrollment

Registered

2012-01-19

Start date

2011-01-31

Completion date

2013-12-31

Last updated

2015-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

ELIGARD, Prostate cancer

Brief summary

The purpose of this study is to evaluate efficacy and safety of ELIGARD 22.5mg in the treatment of subjects with prostate cancer.

Interventions

DRUGELIGARD 22.5mg

a subcutaneous injection of ELIGARD 22.5mg at 0 and 12weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Ratio of subjects whose blood testosterone concentration is maintained below 50ng/dl at 4 weeks after injection of ELIGARD 22.5mg	4weeks

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026