The Efficacy and Safety of FE 200486 in Treatment of Patients Suffering From Prostate Cancer
NCT ID: NCT00819247
Last Updated: 2023-11-09
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
129 participants
INTERVENTIONAL
2001-03-31
2002-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Investigation of a New Trial Drug (FE200486) in Prostate Cancer Patients
NCT00818623
Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
NCT00215657
Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
NCT00117312
Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486
NCT00117949
Dose Finding Trial With a New Treatment (Degarelix) for Prostate Cancer
NCT00819156
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Degarelix 80/80 + 40
Loading doses of Degarelix 80 mg (20 mg/mL) on Days 0 and 3. Maintenance doses of 40 mg (20 mg/mL) given on days 28, 56, 84, 112 and 140.
Degarelix
Given as a subcutaneous injection.
Degarelix 40/40 + 40
Loading doses of Degarelix 40 mg (20 mg/mL) on Days 0 and 3. Maintenance doses of 40 mg (20 mg/mL) given on days 28, 56, 84, 112 and 140.
Degarelix
Given as a subcutaneous injection.
Degarelix 80 + 20
Loading dose of Degarelix 80 mg (20 mg/mL) on Day 0. Maintenance doses of 20 mg (10 mg/mL) given on days 28, 56, 84, 112 and 140.
Degarelix
Given as a subcutaneous injection.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Degarelix
Given as a subcutaneous injection.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Proven prostate cancer with a need for endocrine treatment
* Testosterone level within the normal range for the age
Exclusion Criteria
* Candidate for prostatectomy or radiotherapy
* History of severe asthma, anaphylactic reactions or Quincke's Oedema
* Hypersensitivity towards any component of FE200486
* Cancer disease within the last ten years except for prostate cancer and some skin cancers
* Presenting with significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or infectious disorder. In addition any other condition such as excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator
* Mental incapacity or language barrier
* Having received an investigational product within the last 12 weeks preceding the trial
* Previous participation in this trial
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ferring Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ferring Pharmaceuticals
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Development Support
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ayr Hospital
Ayr, , United Kingdom
Bristol Royal Infirmary
Bristol, , United Kingdom
Southmead Hospital
Bristol, , United Kingdom
St. Richards Hospital
Chichester, , United Kingdom
Glan Clwyd Hospital
Denbighshire, , United Kingdom
Ninewells Hospital
Dundee, , United Kingdom
Southern General Hospital
Glasgow, , United Kingdom
Leicester General Hospital
Leicester, , United Kingdom
Chelsea and Westminster Hospital
London, , United Kingdom
Kings College Hospital
London, , United Kingdom
St. Bartholemews Hospital
London, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Lister Hospital
Stevenage, , United Kingdom
Stirling Royal Infirmary
Stirling, , United Kingdom
Morriston Hospital
Swansea, , United Kingdom
Pindersfields General Hospital
Wakefield, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FE200486 CS02
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.