Know Cancer

or
forgot password

A Phase IIIb, Non-randomized, Open-label, Multi-Centre, Follow-on Safety Trial of Monthly Doses of Degarelix in Patients With Prostate Cancer


Phase 3
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

A Phase IIIb, Non-randomized, Open-label, Multi-Centre, Follow-on Safety Trial of Monthly Doses of Degarelix in Patients With Prostate Cancer


Inclusion Criteria:



- Completed any of the trials; FE 200486 CS27, CS28, CS30 or CS31

Exclusion Criteria:

- Discontinued any of the trials: FE 200486 CS27, CS28, CS30 or CS31

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables

Outcome Description:

The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.

Outcome Time Frame:

Up to 22.5 months

Safety Issue:

Yes

Principal Investigator

Clinical Development Support

Investigator Role:

Study Director

Investigator Affiliation:

Ferring Pharmaceuticals

Authority:

Sweden: Medical Products Agency

Study ID:

FE200486 CS34

NCT ID:

NCT00967018

Start Date:

August 2009

Completion Date:

December 2011

Related Keywords:

  • Prostate Cancer
  • Safety parameters
  • ECG, blood and urine samples
  • general health state
  • Prostatic Neoplasms

Name

Location