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An Open-Label, Multi-Centre, Extension Study Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Patients With Prostate Cancer.


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

An Open-Label, Multi-Centre, Extension Study Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Patients With Prostate Cancer.


Participants who completed the main FE200486 CS12 study initially continued with the same
dose in the FE200486 CS12A extension study. After a protocol amendment all study
participants were treated with 160 mg (40 mg/mL).

The data include data from the participants who participated in both the main study
(FE200486 CS12; NCT00819156) and the extension study FE200486 CS12A.

Inclusion Criteria


Inclusion criteria:

- Had given written consent before any study-related activity was performed (a
study-related activity was defined as any procedure that would not have been
performed during the normal management of the participant)

- Had completed the FE200486 CS12 study

Exclusion criterion:

- Had been withdrawn from the FE200486 CS12 study

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Participants With Markedly Abnormal Change in Vital Signs and Body Weight

Outcome Description:

Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline.

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Clinical Development Support

Investigator Role:

Study Director

Investigator Affiliation:

Ferring Pharmaceuticals

Authority:

Belgium: Federal Agency for Medicines and Health Products, FAMHP

Study ID:

FE200486 CS12A

NCT ID:

NCT00215683

Start Date:

February 2005

Completion Date:

November 2009

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Androgen ablation therapy
  • Prostatic Neoplasms

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