A Phase 2/3 interventional study of Degarelix in Prostate Cancer, sponsored by Ferring Pharmaceuticals. Completed at 22 sites in 2 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-18.
Sponsored by Ferring Pharmaceuticals · Phase 2/3, Interventional, and Treatment
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 Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained.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.
Participants who completed the main FE200486 CS14 study initially continued with the same dose in the FE200486 CS14A extension study. A protocol amendment changed the dosage to 160 mg (40 mg/mL) for all study participants.
The data include data from the participants who participated in both the main study (FE200486 CS14; NCT00116779) and the extension study FE200486 CS14A.
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Exclusion Criterion:
Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
Drug: Degarelix
Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
Drug: Degarelix
Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 28 days until the end of the study.
Also known as: Degarelix acetate, FE200486
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
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.
Time frame: 5 years
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.
Time frame: 5 years
Participants who completed the main FE200486 CS14 study were asked to continue into the FE200486 CS14A extension study.
| Milestone | Degarelix (60 mg to 160 mg) | Degarelix (80 mg to 160 mg) |
|---|---|---|
| Started | 30 | 27 |
| Switched to higher dose | 17 | 17 |
| Completed | 2 | 6 |
| Not completed | 28 | 21 |
| Withdrew: Adverse event | 12 | 6 |
| Withdrew: Lost to follow-up | 2 | 0 |
| Withdrew: Protocol violation | 3 | 3 |
| Withdrew: Withdrawal by subject | 6 | 2 |
| Withdrew: Physician decision | 3 | 7 |
| Withdrew: Lack of efficacy | 2 | 1 |
| Withdrew: Research site closing | 0 | 2 |
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.
| participants | Degarelix (60 mg to 160 mg) | Degarelix (80 mg to 160 mg) |
|---|---|---|
| Diastolic blood pressure <=50 and decrease >=15 | 9 | 4 |
| Diastolic blood pressure >=105 and increase >=15 | 3 | 3 |
| Systolic blood pressure <=90 and decrease >=20 | 3 | 7 |
| Systolic blood pressure >=180 and increase >=20 | 5 | 4 |
| Heart rate <=50 and decrease >=15 | 2 | 6 |
| Heart rate >=120 and increase >=15 | 1 | 0 |
| Body weight decrease of >=7 percent | 6 | 4 |
| Body weight increase of >=7 percent | 6 | 5 |
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.
| participants | Degarelix (60 mg to 160 mg) | Degarelix (80 mg to 160 mg) |
|---|---|---|
| Abnormal alanine aminotransferase (ALAT) | 8 | 11 |
| Abnormal aspartate aminotransferase | 5 | 4 |
| Abnormal bilirubin | 7 | 5 |
| ALAT >3x upper limit of normal (ULN) | 0 | 0 |
| ALAT >3x ULN, bilirubin >1.5x ULN | 0 | 0 |
Collected over 5 years.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Degarelix (60 mg to 160 mg) | — | 11/30 (36.7%) | 29/30 (96.7%) |
| Degarelix (80 mg to 160 mg) | — | 7/27 (25.9%) | 26/27 (96.3%) |
| Event | Degarelix (60 mg to 160 mg) | Degarelix (80 mg to 160 mg) |
|---|---|---|
| PneumoniaInfections and infestations | 3/30 | 0/27 |
| Hiatus herniaGastrointestinal disorders | 2/30 | 0/27 |
| Coronary artery diseaseCardiac disorders | 0/30 | 1/27 |
| VertigoEar and labyrinth disorders | 0/30 | 1/27 |
| Inguinal hernia, obstructiveGastrointestinal disorders | 0/30 | 1/27 |
| NauseaGastrointestinal disorders | 0/30 | 1/27 |
| AstheniaGeneral disorders | 0/30 | 1/27 |
| General physcial health deteriorationGeneral disorders | 0/30 | 1/27 |
| Lumbar spinal stenosisMusculoskeletal and connective tissue disorders | 0/30 | 1/27 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 0/30 | 1/27 |
| Event | Degarelix (60 mg to 160 mg) | Degarelix (80 mg to 160 mg) |
|---|---|---|
| Hot flushVascular disorders | 12/30 | 15/27 |
| FatigueGeneral disorders | 8/30 | 5/27 |
| Weight increasedInvestigations | 4/30 | 7/27 |
| Injection site painGeneral disorders | 7/30 | 6/27 |
| Injection site noduleGeneral disorders | 7/30 | 5/27 |
| NasopharyngitisInfections and infestations | 5/30 | 6/27 |
| Upper respiratory tract infectionInfections and infestations | 5/30 | 6/27 |
| Back painMusculoskeletal and connective tissue disorders | 1/30 | 6/27 |
| ConstipationGastrointestinal disorders | 2/30 | 5/27 |
| Injection site erythemaGeneral disorders | 3/30 | 5/27 |
| Age, Continuous(years) | Degarelix (60 mg to 160 mg) | Degarelix (80 mg to 160 mg) | Total |
|---|---|---|---|
| Mean | 76.0 ± 6.63 | 74.1 ± 8.85 | 75.1 ± 7.75 |
| Sex: Female, Male(Participants) | Degarelix (60 mg to 160 mg) | Degarelix (80 mg to 160 mg) | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 30 | 27 | 57 |
| Race (NIH/OMB)(Participants) | Degarelix (60 mg to 160 mg) | Degarelix (80 mg to 160 mg) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 2 | 7 |
| White | 24 | 25 | 49 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Body weight(kilogram) | Degarelix (60 mg to 160 mg) | Degarelix (80 mg to 160 mg) | Total |
|---|---|---|---|
| Mean | 79.0 ± 11.4 | 81.3 ± 13.3 | 80.1 ± 12.2 |
| Body mass index(kilogram per square meter) | Degarelix (60 mg to 160 mg) | Degarelix (80 mg to 160 mg) | Total |
|---|---|---|---|
| Mean | 26.5 ± 3.64 | 26.6 ± 4.63 | 26.5 ± 4.10 |
| Curative Intent(participants) | Degarelix (60 mg to 160 mg) | Degarelix (80 mg to 160 mg) | Total |
|---|---|---|---|
| Yes | 11 | 11 | 22 |
| No | 19 | 16 | 35 |
| Gleason Score(participants) | Degarelix (60 mg to 160 mg) | Degarelix (80 mg to 160 mg) | Total |
|---|---|---|---|
| 2-4 | 2 | 1 | 3 |
| 5-6 | 5 | 8 | 13 |
| 7-10 | 23 | 18 | 41 |
| Stage of Prostate Cancer(participants) | Degarelix (60 mg to 160 mg) | Degarelix (80 mg to 160 mg) | Total |
|---|---|---|---|
| Localized | 14 | 7 | 21 |
| Locally advanced | 3 | 5 | 8 |
| Metastatic | 5 | 5 | 10 |
| Not classifiable | 8 | 10 | 18 |
1 further baseline measures are reported on the registry.
This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.
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Ferring Pharmaceuticals