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A Degarelix Trial in Patients With Prostate Cancer

NCT01242748 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2015-06-03

Study results available
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Summary

A phase III extension trial comparing the efficacy and safety of degarelix 3 month depot with the established therapy Zoladex 3 month implant in patients with prostate cancer.

Conditions

Interventions

DRUG

Degarelix

The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.

DRUG

Goserelin acetate

The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Clinical Development Support · Ferring Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-12-31
Completion
2012-01-31

Countries

  • United States
  • Belgium
  • Canada
  • Czechia
  • Finland
  • Germany
  • Hungary
  • Mexico
  • Netherlands
  • Poland
  • Romania
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT01242748 on ClinicalTrials.gov