Clinical Trial Results:
Ensayo clínico abierto, aleatorizado, de grupos paralelos que compara degarelix frente a bloqueo androgénico combinado (goserelina + bicalutamida) en términos de reducción de la puntuación en la escala internacional de síntomas prostáticos (IPSS) en pacientes con síntomas del tracto urinario inferior (LUTS) asociados a cáncer de próstata localmente avanzado
A randomised, parallel-arm, open-label trial comparing degarelix with goserelin plus anti-androgen flare protection (bicalutamide), in terms of reduction in International Prostate Symptom Score (IPSS), in patients with lower urinary tract symptoms (LUTS) secondary to locally advanced prostate cancer
Summary
|
|
EudraCT number |
2008-004338-26 |
Trial protocol |
ES GB DE |
Global completion date |
03 Mar 2010
|
Paediatric regulatory details
|
|
Is the trial part of an agreed EMA paediatric investigation plan? |
No
|
Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
|
Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
02 Feb 2016
|
First version publication date |
28 May 2015
|
Other versions |
|
Summary report(s) |
FE 200486 CS28 summary report |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.