Phase 3 Completed N=157 Treatment

Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Korean Patients

Prostate Cancer

Source: ClinicalTrials.gov NCT01215513 ↗

Enrolled (actual)

157

Serious AEs

16.0%

Results posted

May 2013

Primary outcomePrimary: Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables — 1; 1; 10; 2 Participants

Summary

This is an open-label, multi-centre single arm trial to investigate long-term safety and tolerability of degarelix in Korean patients with prostate cancer.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables	1; 1; 10; 2; 1; 10	—
PRIMARY Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight	13; 0; 20; 1; 10; 0	—
PRIMARY Number of Participants With Markedly Abnormal Values in ECG Variables	1; 3; 3; 27; 6; 2	—
SECONDARY Serum Levels of Prostate Specific Antigen (PSA) Over Time	19.2; 0.67; 0.52; 0.46	—

Eligibility Criteria

Inclusion Criteria

Has given written informed consent before any trial-related activity is performed. A trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient
Has completed the 7-month main trial, FE200486 CS42

Exclusion Criteria

Has been withdrawn/discontinued from the FE200486 CS42 trial
A patient may also not be entered into the CS42A trial at the discretion of the investigator due to safety or lack of efficacy concerns (LH or PSA response) in the CS42 trial.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01215513). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.