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The Efficacy and Safety of FE 200486 in Treatment of Patients Suffering From Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00819247
Recruitment Status : Completed
First Posted : January 8, 2009
Results First Posted : March 31, 2009
Last Update Posted : May 20, 2011
Information provided by:
Ferring Pharmaceuticals

Brief Summary:
The purpose of this trial was to select a dose of degarelix (FE 200486). Three groups of patients were treated for six months on different doses. The patients had blood samples taken and measured for Testosterone in order to determine the most efficient dose to provide fast and sustained castration. The patients came to the clinic for 16 visits and dependent on the blood sample results they were invited to return for additional blood samples on a two weekly basis.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Degarelix Phase 2

Detailed Description:
Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Six Month, Multi-centre, Open-labelled, 1:1:1 Randomised, Parallel Group Study Investigating the Efficacy and Safety of Three Dose Regimens of FE 200486 in Prostate Cancer Patients
Study Start Date : March 2001
Actual Primary Completion Date : May 2002
Actual Study Completion Date : August 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Degarelix

Arm Intervention/treatment
Experimental: 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.
Drug: Degarelix
Given as a subcutaneous injection.
Other Name: FE 200486

Experimental: 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.
Drug: Degarelix
Given as a subcutaneous injection.
Other Name: FE 200486

Experimental: 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.
Drug: Degarelix
Given as a subcutaneous injection.
Other Name: FE 200486

Primary Outcome Measures :
  1. Number of Participants With Testosterone <0.5 Nanogram/Milliliter [ Time Frame: Weeks 1,2,4,8,12,16,20,24 ]

Secondary Outcome Measures :
  1. Number of Participants With Testosterone < 0.5 Nanogram/Milliliter at All Visits Between Weeks 4-24 [ Time Frame: Weeks 4-24 ]
  2. Number of Participants Not Meeting a Testosterone Withdrawal Criterion Between Weeks 4-24 [ Time Frame: Weeks 4-24 ]
    Participants with one testoterone value > 1.0 nanogram/millliliter or two consecutive values between 0.5-1.0 nanogram/milliliter were withdrawn from the study due to insufficient response.

  3. Number of Participants Who Met the Withdrawl Criteria for Prostate-specific Antigen [ Time Frame: Six months ]
    Participants who met at least one of the three criteria for inadequate response on prostate-specific antigen levels (PA). (1) >=25 percent and/or 50 nanogram/milliliter compared to baseline (2) reduction of <=50% compared to baseline at week 12 (3) increase of >=10 nanogram/milliliter compared to nadir from week 4.

  4. Number of Participants With Normal Prostate-specific Antigen Levels During the Study [ Time Frame: Weeks 12, 24 ]
    The number of participants whose prostate-specific antigen levels at weeks 12 and 24 were <= 4 nanogram/millliliter (normal level).

  5. The Number of Participants With Abnormal Liver Function Tests [ Time Frame: Six months ]
    The number of participants who had abnormal [defined as above upper limit of normal range (ULN)] alanine aminotransferase (ALT), participants with ALT increases > 3x ULN, and participants with ALT increases > 3x ULN with concurrent increases in bilirubin > 1.5 ULN.

  6. Percentage Change in Vital Signs and Body Weight [ Time Frame: Baseline and Six months ]
    Percentage changes in vital signs (systolic and diastolic blood pressure and pulse) and body weight at the end of trial as compared to baseline.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed informed consent before any trial related activity
  • Proven prostate cancer with a need for endocrine treatment
  • Testosterone level within the normal range for the age

Exclusion Criteria:

  • Previous or current hormonal treatment of prostate cancer
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00819247

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United Kingdom
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
Sponsors and Collaborators
Ferring Pharmaceuticals
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Study Director: Clinical Development Support Ferring Pharmaceuticals
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Responsible Party: Clinical Development Support, Ferring Pharmaceuticals Identifier: NCT00819247    
Other Study ID Numbers: FE200486 CS02
First Posted: January 8, 2009    Key Record Dates
Results First Posted: March 31, 2009
Last Update Posted: May 20, 2011
Last Verified: May 2011
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases