Clinical trial · Interventional
Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Korean Patients
An Open-Label, Multi-Centre, Extension Trial, Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Korean Patients Requiring Androgen Ablation Therapy
NCT01215513CI-TRIAL-00010388completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Degarelix | Drug | Degarelix | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Degarelix
- interventionNames
- Drug: Degarelix
Primary outcomes (3)
- measure
- Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
- timeFrame
- From baseline (day 0) to end of treatment (up to day 364)
- description
- The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one participant with abnormal value are presented, more variables were included in the study. ULN=upper limit of normal
- measure
- Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
- timeFrame
- From baseline (day 0) to end of treatment (up to day 364)
- description
- This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The figures present the number of participants with normal baseline and at least one post-baseline markedly abnormal value.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.