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An Open-Label, Multi-Center, Ascending, Single Dose Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486

Phase 2
18 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

An Open-Label, Multi-Center, Ascending, Single Dose Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486

Inclusion Criteria:

Each patient must meet the following inclusion criteria before entry into the study:

- Has given written consent before any study related activity is performed (A study
related activity is defined as any procedure that would not have been performed
during the normal management of the patient.)

- Is a male patient with histologically proven adenocarcinoma of the prostate (all
stages) in whom endocrine treatment is indicated, except for neoadjuvant hormonal
therapy. For patients, prostate-specific antigen (PSA) increases on two consecutive
determinations at least 2 weeks apart prior to Visit 1 must be documented.

- Is at least 18 years.

- Has an ECOG score of 2.

- Has a baseline testosterone level within the age specific normal range as measured by
the central laboratory.

- Has a PSA value of 2 ng/mL as measured by the central laboratory.

- Has a life expectancy of at least 6 months.

Exclusion Criteria:

Any patient meeting one or more of the following exclusion criteria will not be entered
into the study:

- Previous or present hormonal management of prostate cancer (surgical castration or
other hormonal manipulation, e.g. GnRH agonists, GnRH antagonists, antiandrogens,
estrogens, PC-Spec) except for neoadjuvant hormonal therapy of < 6 months duration
and completed > 6 months prior to Visit 1.

- Requires hormonal therapy for neoadjuvant purposes.

- Is recently (within the last 12 weeks preceding Visit 1) or presently treated with
any other drug modifying the testosterone level or function.

- Is considered to be a candidate for curative therapy, i.e., radical prostatectomy or
radiotherapy within 6 months after Visit 1.

- Has a history of severe asthma requiring daily treatment with inhalation steroids,
angioedema or anaphylactic reactions.

- Has hypersensitivity towards any component of the investigational product.

- Has had a cancer disease within the last 10 years except for prostate cancer, and
surgically removed basocellular or squamous cell carcinoma of the skin.

- Has a clinically significant neurologic, gastrointestinal, renal, hepatic,
cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological,
dermatological or infectious disorder or any other condition, including excessive
alcohol or drug abuse, which may interfere with trial participation, or which may
affect the conclusion of the study, as judged by the investigator.

- Any clinically significant laboratory abnormalities which, in the judgment of the
investigator, would interfere with the patient's participation in this study or
evaluation of study results (liver transaminases must be within normal limits).

- Has a mental incapacity or language barrier precluding adequate understanding or

- Has received an investigational drug within the last 12 weeks preceding Visit 1.

- Has previously participated in this study.

Type of Study:


Study Design:

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

Outcome Measure:

Time to Meet Insufficient Testosterone Response

Outcome Description:

Figures in the table are Kaplan-Meier estimates of the time to meeting insufficient testosterone response. Insufficient testosterone response was defined as testosterone >1.0 ng/mL at one visit or testosterone 0.5-1.0 at two consecutive visits.

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

Clinical Development Support

Investigator Role:

Study Director

Investigator Affiliation:

Ferring Pharmaceuticals


United States: Food and Drug Administration

Study ID:

FE200486 CS06



Start Date:

April 2002

Completion Date:

January 2004

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Androgen ablation therapy
  • Prostatic Neoplasms



Advanced Urology Medical Center Anaheim, California  92801
Urology San Antonio Research San Antonio, Texas  78229
Pinellas Urology, Inc. St. Petersburg, Florida  33710
South Orange County Medical Research Center Laguna Hills, California  92653
Nevada Urology Associates Reno, Nevada  89511
Western Clinical Research Torrance, California  90505
San Bernardino Urological Associates Medical Group San Bernardino, California  92404
SW Florida Urological Associates Fort Myers, Florida  33907
Urology Associate PC` Denver, Colorado  80210
Drs. Werner, Murdock & Francis, PA Greenbelt, Maryland  20770
Urology Specialists of Oklahoma, Inc. Tulsa, Oklahoma  74104
Urology Clinics of NorthTexas, PA Dallas, Texas  75231