Study Investigating the Long-Term Safety and Tolerability of Repeated Doses of Degarelix in Prostate Cancer Patients

NCT ID: NCT00245466

Last Updated: 2011-05-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-10-31
• Study Completion Date: 2006-03-31

Brief Summary

To investigate the long-term safety and tolerability of repeated doses of degarelix to prostate cancer patients

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 (FDA regulated intervention is therefore ticked "YES").

The data include participants from both the main study (FE200486 CS02; NCT00819247) and the extension study FE200486 CS02A.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Degarelix 80/80 + 40

In the main study (FE200486 CS02; NCT00819247) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.

Group Type: EXPERIMENTAL

Degarelix

Intervention Type: DRUG

Given as a subcutaneous injection once every 4 weeks.

Degarelix 40/40 + 40

In the main study (FE200486 CS02; NCT00819247) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.

Group Type: EXPERIMENTAL

Degarelix

Intervention Type: DRUG

Given as a subcutaneous injection once every 4 weeks.

Degarelix 80 + 20

In the main study (FE200486 CS02; NCT00819247) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.

Group Type: EXPERIMENTAL

Degarelix

Intervention Type: DRUG

Given as a subcutaneous injection once every 4 weeks.

Interventions

Degarelix

Given as a subcutaneous injection once every 4 weeks.

Intervention Type: DRUG

Degarelix

Given as a subcutaneous injection once every 4 weeks.

Intervention Type: DRUG

Degarelix

Given as a subcutaneous injection once every 4 weeks.

Intervention Type: DRUG

Other Intervention Names

FE200486; FE200486; FE200486

Eligibility Criteria

Inclusion Criteria

• Has completed study treatment in study FE200486 CS02.
• Has completed visit 16 in study FE200486 CS02.
• Has not met any withdrawal criteria up to and including visit 15 in FE200486 CS02

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Ferring Pharmaceuticals

Principal Investigators

Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Other Identifiers

FE200486 CS02A

Identifier Type: -

Identifier Source: org_study_id