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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


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Testosterone <0.5 Nanogram/Milliliter

Outcome Time Frame:

Weeks 1,2,4,8,12,16,20,24

Safety Issue:

No

Principal Investigator

Clinical Development Support

Investigator Role:

Study Director

Investigator Affiliation:

Ferring Pharmaceuticals

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

FE200486 CS02

NCT ID:

NCT00819247

Start Date:

March 2001

Completion Date:

August 2002

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

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