COMPLETEDResults postedPhase 2Phase 3

Extension Study Investigating the Long-Term Safety of Degarelix One-Month Depots in Patients With Prostate Cancer

This was an extension study for the study FE200486 CS14 (NCT00116779). Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained. The study was terminated when all ongoing participants had been treated for at least 5 years.

Sponsor

Ferring Pharmaceuticals

Enrollment

57 participants

Sites

22 locations

Start Date

March 2005

Completion

September 2009

Prostate CancerDegarelix

Enrollment & Timeline

Completed

Target N

participants

Sites

locations

Duration

4.7 years

total trial span

Rate

pts/month needed

At 22 sites, each site needs to enroll approximately 0.0 patients/month to hit the enrollment target on schedule.

View on ClinicalTrials.gov

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Primary Outcomes

Participants With Markedly Abnormal Change in Vital Signs and Body Weight

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Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

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Fetching protocol from ClinicalTrials.gov…

COMPLETEDResults postedPhase 2Phase 3

Extension Study Investigating the Long-Term Safety of Degarelix One-Month Depots in Patients With Prostate Cancer

Sponsor

Ferring Pharmaceuticals

Enrollment

57 participants

Sites

22 locations

Start Date

March 2005

Completion

September 2009

Prostate CancerDegarelix

Enrollment & Timeline

Completed

Target N

participants

Sites

locations

Duration

4.7 years

total trial span

Rate

pts/month needed

At 22 sites, each site needs to enroll approximately 0.0 patients/month to hit the enrollment target on schedule.

View on ClinicalTrials.gov

Ask AI

Primary Outcomes

Participants With Markedly Abnormal Change in Vital Signs and Body Weight

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

This outcome measure 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 participants in each group with normal baseline and markedly abnormal value post-baseline.

Liver Function Tests

5 years

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.

Eligibility

Min Age

18 Years

Sex

male

Healthy Volunteers

View full criteria

Inclusion Criteria:

* Has given written consent prior to any study-related activity being performed. A study-related activity is defined as any procedure that would not have been performed during the normal management of the patient.
* Has completed study FE200486 CS14 through visit 22.

Exclusion Criterion:

* Has been withdrawn from the FE200486 CS14 study.

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Extension Study Investigating the Long-Term Safety of Degarelix One-Month Depots in Patients With Prostate Cancer

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Extension Study Investigating the Long-Term Safety of Degarelix One-Month Depots in Patients With Prostate Cancer

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Eligibility

Trial Sites (22)