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

Prostate Cancer Clinical Trial

Official title:

An Open-Label, Multi-Centre, Extension Study Investigating the Long-Term Safety and Tolerability of Repeated Doses of Degarelix in Prostate Cancer Patients.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00245466
• Other study ID #: FE200486 CS02A
• Status: Terminated
• Phase: Phase 2
• First received: October 26, 2005
• Last updated: May 18, 2011
• Start date: October 2001
• Est. completion date: March 2006

Study information

• Verified date: May 2011
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 88
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Degarelix
Given as a subcutaneous injection once every 4 weeks.
• Degarelix
Given as a subcutaneous injection once every 4 weeks.
• Degarelix
Given as a subcutaneous injection once every 4 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver Function Tests	The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.	3 years	No
Primary	Participants With Markedly Abnormal Change in Vital Signs and Body Weight	Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of patients in each group with normal baseline and markedly abnormal value post-baseline.	3 years	No
Secondary	Serum Levels of Testosterone After 1, 2, and 3 Years		3 years	No