A Long Term Safety Study of Degarelix in Patients With Prostate Cancer

January 2, 2013 updated by: Ferring Pharmaceuticals

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

Patients that completed any of the trials; CS27 (NCT00738673), CS28 (NCT00831233), CS30 (NCT00833248) or CS31 (NCT00884273) will be given the opportunity to receive monthly doses of degarelix until the drug is launched in their country. Safety parameters such as electrocardiogram (ECG), blood and urine samples and general health state will be studied. Note: patients completing the CS27 trial did not participate in the CS34 trial.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
77

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium
        • Institut Jules Bordet
      • Turnhout, Belgium
        • St. Elisabethziekenhuis
  • France
      • Besancon, France
        • Hôpital Jean Minjoz
      • Bordeaux Cedex, France
        • Institut Bergonie
      • Caen, France
        • Centre Francois Baclesse
      • Creteil, France
        • CHU Henri Mondor
      • Lille, France
        • Centre Oscar Lambret
      • Lyon, France
        • Centre Leon Berard
      • Marseille, Cedex, France
        • Hôpital de la Timone
      • Montpellier, France
        • CRLC Val d' Aurelle - Oncology Radiotherapy
      • Paris, France
        • Hopital Tenon
      • Paris, France
        • Hôpital Saint Louis - Radiotherapy Departement
      • Perigueux, France
        • Clinique Francheville
      • Poitiers, France
        • CHU La Milétrie - Oncology Radiotherapy
      • Saint Herblain Cedex, France
        • Centre de Lutte Contre le Cancer Nantes-Atlantique Centre René Gauducheau
      • Saint Priest en Jarez, France
        • Institut de Cancerologie de La Loire
      • St Brieuc Cedex, France
        • Clinique Saint Brieuc
      • Strassbourg, France
        • Centre Paul Strauss
      • Toulon, France
        • Centre de radiologie Saint Louis
      • Toulouse, France
        • Clinique du Parc
      • Villejuif, France
        • IGR
  • Italy
      • Ancona, Italy
        • Azienda Ospedaliero Universitaria Ospedali Riuniti
      • Bologna, Italy
        • Policlinico S.Orsola Malpighi - Universita' degli Studi di Bologna
      • Firenze, Italy
        • Clinica Urologica 1 Universita Firenze
      • Milano, Italy
        • Fondazione IRCCS Istituto Nazionale Tumori
      • Milano, Italy
        • Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
      • Napoli, Italy
        • Azienda Ospedaliera Universitaria Federico II
      • Palermo, Italy
        • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone dell'Universita' degli Studi di Palermo
      • Perugia, Italy
        • Clinica Urologica - Azienda Ospedaliera di Perugia
      • Roma, Italy
        • Azienda Ospedaliera S. Andrea - Universita' la Sapienza di Roma
      • San Giovanni Rotondo, Italy
        • S.C. Di Urologia - IRCCS Ospedale Casa Sollievo della Sofferenza
      • Torino, Italy
        • Azienda Ospedaliero Universitaria S. Giovanni Battista - Molinette
  • Portugal
      • Amadora, Portugal
        • Hospital Fernando da Fonseca
      • Coimbra, Portugal
        • Hospitais Universidade Coimbra
      • Lisboa, Portugal
        • Centro Hospitalar Lisboa Norte, Hospital Santa Maria
      • Porto, Portugal
        • Hospital S.JOÃO
  • Spain
      • Alcalá de Henares-Madrid, Spain
        • Hospital Universitario Príncipe de Asturias
      • Alcorcon, Spain
        • Fundacion Hospital Alcorcon
      • Barcelona, Spain
        • Hospital De La Santa Creu I Sant Pau
      • Barcelona, Spain
        • Hospital Universitari Vall d´Hebron
      • Barcelona, Spain
        • Fundacion Puigvert
      • Bilbao, Spain
        • Hospital de Basurto
      • Madrid, Spain
        • Hospital Doce de Octubre
      • Madrid, Spain
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain
        • Hospital Clinico Universitario S. Carlos
      • Majadahonda, Spain
        • Hospital Universitario Puerta de Hierro
      • Manacor, Spain
        • Hospital Manacor
      • Oviedo, Spain
        • Hospital Universitario Central de Asturias
      • Santiago de Compostela, Spain
        • Hospital Santiago de Compostela
      • Sevilla, Spain
        • Hospital Virgen Macarena
      • Valencia, Spain
        • Fundacion IVO
      • Vigo, Spain
        • Hospital Xeral de Vigo
  • Sweden
      • Göteborg, Sweden
        • Investigational Site
      • Göteborg, Sweden
        • SU/Sahlgrenska
      • Helsingborg, Sweden
        • Helsingborgs lasarett
      • Malmö, Sweden
        • Universitetssjukhuset MAS
      • Södertälje, Sweden
        • Södertälje Sjukhus
      • Uppsala, Sweden
        • Uppsala/Akademiska sjukhuset
  • Turkey
      • Ankara, Turkey
        • Ankara University Faculty of Medicine - Sıhhıye
      • Istanbul, Turkey
        • Cerrahpasa Faculty of Medicine - Kocamustafapasa
      • Istanbul, Turkey
        • Istanbul University Faculty of Medicine - ÇAPA
      • Istanbul, Turkey
        • Marmara University Faculty of Medicine - Altunizade

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Degarelix
The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
Drug: Degarelix

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
Time Frame: Up to 22.5 months
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.
Up to 22.5 months
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
Time Frame: Up to 22.5 months
This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.
Up to 22.5 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serum Levels of Prostate Specific Antigen (PSA)Over Time
Time Frame: from baseline to 72 weeks
PSA levels were measured over time. The table below shows median levels at baseline (n=77 participants), 24 weeks (n=56), 36 weeks (n=58), 48 weeks (n=48), 72 weeks (n=9)
from baseline to 72 weeks
Serum Levels of Testosterone Over Time
Time Frame: from baseline to week 72
Testosterone levels were measured over time. The table below shows median levels at baseline (n=77 participants), 24 weeks (n=68), 36 weeks (n=59), 48 weeks (n=54), 72 weeks (n=9)
from baseline to week 72

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 3, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FE200486 CS34
  • EudraCT No: 2008-006827-29

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Clinical Trials on Degarelix

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings