Clinical trial NCT00117286: Extension Study Investigating the Long-Term Safety of Degarelix One-Month Depots in Patients With Prostate Cancer
Official title: An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Patients With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Androgen ablation therapy
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-07-06
Enrollment: 57
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was an extension study for the study FE200486 CS14 (NCT00116779). Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained.

The study was terminated when all ongoing participants had been treated for at least 5 years.

Detailed description: Participants who completed the main FE200486 CS14 study initially continued with the same dose in the FE200486 CS14A extension study. A protocol amendment changed the dosage to 160 mg (40 mg/mL) for all study participants.

The data include data from the participants who participated in both the main study (FE200486 CS14; NCT00116779) and the extension study FE200486 CS14A.

Eligibility criteria: Inclusion Criteria:

* Has given written consent prior to any study-related activity being performed. A study-related activity is defined as any procedure that would not have been performed during the normal management of the patient.
* Has completed study FE200486 CS14 through visit 22.

Exclusion Criterion:

* Has been withdrawn from the FE200486 CS14 study.

Primary outcomes:
measure: Participants With Markedly Abnormal Change in Vital Signs and Body Weight
timeFrame: 5 years
measure: Liver Function Tests
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Urology Centers of Alabama
state: Alabama
city: Anaheim
country: United States
facility: Advanced Urology Medical Center
state: California
city: Tarzana
country: United States
facility: West Coast Clinical Research
state: California
city: Torrance
country: United States
facility: Western Clinical Research
state: California
city: Denver
country: United States
facility: Urology Associate PC'
state: Colorado
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Fort Myers
country: United States
facility: SW Florida Urological Associates
state: Florida
city: Fort Wayne
country: United States
facility: Northeast Indiana Research, LLC
state: Indiana
city: Shreveport
country: United States
facility: Regional Urology
state: Louisiana
city: Lawrenceville
country: United States
facility: Lawrenceville Urology
state: New Jersey
city: Greensboro
country: United States
facility: The Urology Center
state: North Carolina
city: State College
country: United States
facility: State College Urologic Association
state: Pennsylvania
city: Providence
country: United States
facility: University Urological Research Institute
state: Rhode Island
city: San Antonio
country: United States
facility: Urology San Antonio Research
state: Texas
city: South Burlington
country: United States
facility: University of Vermont, Dept of Surgery
state: Vermont
city: Richmond
country: United States
facility: Virginia Urology Center
state: Virginia
city: Seattle
country: United States
facility: Investigational site
state: Washington
city: Victoria
country: Canada
facility: Can-Med Clinical Research, Inc.
state: British Columbia
city: Barrie
country: Canada
facility: The Male and Female Health and Research Centers
state: Ontario
city: Brantford
country: Canada
facility: Brantford Urology Research
state: Ontario
city: Burlington
country: Canada
facility: Burlington Professional Care
state: Ontario
city: Oakville
country: Canada
facility: The Female/Male Health Centres
state: Ontario
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: