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An Open-Label, Multi-Centre, Extension Study, Evaluating the Long-Term Safety and Tolerability of Different Three-Month Degarelix Dosing Regimens 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 Different Three-Month Degarelix Dosing Regimens in Patients With Prostate Cancer


The data include data from the participants who participated in both the main study FE200486
CS15 (NCT00113753) and the extension study FE200486 CS15A.


Inclusion Criteria:



- Has given written consent prior to any study-related activity is performed. A
study-related activity is defined as any procedure that would not have been performed
during the normal management of the patient.

- Has successfully completed the main study.

Exclusion Criterion:

- Has been withdrawn from the main study.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:

Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight

Outcome Description:

This outcome measure included incidence of markedly abnormal values in blood pressure (systolic and diastolic), pulse, and body weight during the trial. The table presents the number of participants with a normal baseline value and at least one post-baseline markedly abnormal value.

Outcome Time Frame:

Baseline and up to 4.5 years

Safety Issue:

No

Principal Investigator

Clinical Development Support

Investigator Role:

Study Director

Investigator Affiliation:

Ferring Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

FE200486 CS15A

NCT ID:

NCT00268892

Start Date:

January 2006

Completion Date:

December 2009

Related Keywords:

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

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