Investigation of a New Trial Drug (FE200486) in Prostate Cancer Patients

NCT00818623 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2023-11-30

Study results available
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Summary

The purpose of this trial was to find an optimal dose for a new trial drug - degarelix (FE200486) - in the treatment of prostate cancer. Furthermore the safety of the drug was studied. Patients participating were treated with FE200486 on one occasion. Thereafter they came in for visits following a specific schedule until blood samples showed that there was no further effect.

Conditions

Interventions

DRUG

Degarelix

Degarelix (120 mg (20 mg/mL)) was given as a subcutaneous injection

DRUG

Degarelix

Degarelix (120 mg (40 mg/mL)) was given as a subcutaneous injection

DRUG

Degarelix

Degarelix (160 mg (40 mg/mL)) was given as a subcutaneous injection

DRUG

Degarelix

Degarelix (200 mg (40 mg/mL)) was given as a subcutaneous injection

DRUG

Degarelix

Degarelix (200 mg (60 mg/mL)) was given as a subcutaneous injection

DRUG

Degarelix

Degarelix (240 mg (40 mg/mL)) was given as a subcutaneous injection

DRUG

Degarelix

Degarelix (240 mg (60 mg/mL)) was given as a subcutaneous injection

DRUG

Degarelix

Degarelix (320 mg (60 mg/mL)) was given as a subcutaneous injection

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Clinical Development Support · Ferring Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-11-30
Primary Completion
2004-10-31
Completion
2004-10-31

Countries

  • Denmark
  • Finland
  • Hungary
  • Norway
  • Romania
  • Russia
  • Sweden

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00818623 on ClinicalTrials.gov