At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 220 enrolled
Drug / intervention
Degarelix 240 mg / 80 mgdrug
Likely dose
Degarelix 240 mg / 80 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Multi-Centre, Uncontrolled, Trial Investigating Degarelix One-Month Dosing Regimen Administered as Intermittent Androgen Deprivation (IAD) for One or More Cycles in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy
In Brief
A Phase 3 clinical trial evaluating Degarelix 240 mg / 80 mg for Prostate Cancer. Completed, enrolled 220 participants across 52 sites in 6 countries.
Detailed Summary
The purpose of this uncontrolled, multi-center, open-label trial was to investigate the feasibility of using degarelix as intermittent androgen deprivation (IAD) therapy in the treatment of prostate cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesBelgium, France, Germany, Italy, Netherlands, Spain
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2008
First PostedDec 2008
Primary CompletionJun 2012
Study CompletionJul 2013
TodayJul 2026
First PostedDec 3, 2008
Enrollment StartDec 1, 2008
Primary CompletionJun 1, 2012
Study CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 17.6 years ago
Interventions
Degarelix 240 mg / 80 mgdrug
For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.