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

Ferring

Status and phase: Terminated; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: Degarelix

Study type: Interventional

Funder types: Industry

Identifiers

NCT00245466

FE200486 CS02A

Details and patient eligibility

About

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

Full 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.

Enrollment: 88 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 3 patient groups

Degarelix 80/80 + 40

Experimental group

Description:

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.

Treatment:

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Degarelix 40/40 + 40

Experimental group

Description:

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.

Treatment:

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Degarelix 80 + 20

Experimental group

Description:

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.

Treatment:

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix