TerminatedNCT00117312Updated May 23, 2011Results posted

Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients

A Phase 2 interventional study of Degarelix and Degarelix in Prostate Cancer, sponsored by Ferring Pharmaceuticals. Terminated at 12 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-05-23.

Sponsored by Ferring Pharmaceuticals · Phase 2, Interventional, and Treatment

Why this study was terminated

After 190 weeks \[7 patients left\] it was terminated for administrative reasons

Phase: Phase 2
Study type: Interventional
Enrollment: 37
Allocation: Randomized
Ages: 18 Years and older
Sex: Male

Study summary

Participants responding well in Study FE200486 CS06 (NCT00117949) were given the opportunity to continue treatment with degarelix under a clinical study until FE200486 was available on the market or until the study was discontinued.

Study FE200486 CS06A was to provide knowledge of the long-term safety and tolerability of FE200486.

Read the detailed description

The data include participants from both the main study (FE200486 CS06; NCT00117949) and the extension study FE200486 CS06A.

Conditions studied

Prostate Cancer

Browse trials for

Prostatic Neoplasms 6,370

Keywords

Prostate Cancer
Androgen ablation therapy

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 37 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Ferring Pharmaceuticals is the lead sponsor of 244 studies on the registry; 4 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 13 (93%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Male
Accepts healthy volunteers: No

Inclusion criteria

Each patient must meet the following inclusion criteria before entry into the study:

Has given written consent before any study related activity is performed. A study related activity is defined as any procedure that would not have been performed during the normal management of the patient.
Has had sufficient testosterone suppression (as defined in the withdrawal criteria of FE200486 CS06) for at least 28 days.

Exclusion criteria

Exclusion Criteria:

Any patient meeting any of the following exclusion criteria will not be entered into the study:

Has been withdrawn from Study FE200486 CS06 due to an adverse event, failure to achieve at least 28 days of testosterone suppression, insufficient prostate-specific antigen (PSA) suppression as defined in Study FE200486 CS06 in the absence of concomitant rise in testosterone level or non-compliance with protocol required procedures.
Requires hormonal therapy for neoadjuvant purposes.
Requires treatment with any other drug modifying the testosterone level or function.
Is considered to be a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy, within 6 months after Visit 1.
Has a history of severe asthma requiring daily treatment with inhalation steroids, angioedema or anaphylactic reactions.
Has hypersensitivity towards any component of the investigational product.
Has had a cancer disease within the last 10 years except for prostate cancer, and surgically removed basocellular or squamous cell carcinoma of the skin.
Has a clinically significant neurologic, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, dermatological or infectious disorder or any other condition, including excessive alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion of the study, as judged by the investigator.
Any clinically significant laboratory abnormalities which, in the judgment of the investigator, would interfere with the patient's participation in this study or evaluation of study results (liver transaminases and bilirubin must be within normal limits).
Has a mental incapacity or language barrier precluding adequate understanding or co-operation.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 37 participants (actual)

Study arms

Experimental
Degarelix 40 mg
Degarelix 40 mg (10 mg/mL)
Drug: Degarelix
Experimental
Degarelix 80 mg
Degarelix 80 mg (20 mg/mL)
Drug: Degarelix
Experimental
Degarelix 120 mg
Degarelix 120 mg (30 mg/mL)
Drug: Degarelix
Experimental
Degarelix 160 mg
Degarelix 160 mg (40 mg/mL)
Drug: Degarelix

Interventions

DrugDegarelix
One dose (2 x 2 mL) of degarelix 40 mg (10 mg/mL), subcutaneous injection.
Also known as: FE200486
DrugDegarelix
One dose (2 x 2 mL) of degarelix 80 mg (20 mg/mL), subcutaneous injection.
Also known as: FE200486
DrugDegarelix
One dose (2 x 2 mL) of degarelix 120 mg (30 mg/mL), subcutaneous injection.
Also known as: FE200486
DrugDegarelix
One dose (2 x 2 mL) of degarelix 160 mg (40 mg/mL), subcutaneous injection.
Also known as: FE200486

What researchers measure

Primary outcomes

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: 3 years
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Vital signs and body weight 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: 3 years

Results

Posted Mar 20, 2009

Participant flow

Participants who responded to degarelix in FE200486 CS06 (NCT00117949) were eligible to enroll into this extension study with the intention of continuing treatment until degarelix became commercially available in the US or until the study was discontinued. Participants received the same dose of degarelix as they received in FE200486 CS06.

Participant flow — Overall Study
Milestone	Degarelix 40 mg	Degarelix 80 mg	Degarelix 120 mg	Degarelix 160 mg
Started	10	24	24	24
Started fe200486 cs06a	1	11	16	9
Completed	0	4	0	3
Not completed	10	20	24	21
Withdrew: Testosterone >1.0 ng/ml	9	9	5	9
Withdrew: Testosterone 0.5 - 1.0 ng/ml	1	0	3	2
Withdrew: Prostate-specific antigen increase >=25%	0	1	5	3
Withdrew: Other	0	1	3	1
Withdrew: Patient choice	0	0	2	1
Withdrew: Adverse event	0	2	0	0
Withdrew: Protocol violation	0	1	3	0
Withdrew: Psa decrease <=50%	0	2	2	4
Withdrew: Psa increase >= 10ng/ml	0	1	1	0
Withdrew: Hepatic abnormality	0	1	0	1
Withdrew: Withdrawal by subject	0	2	0	0

Outcome measures

PrimaryLiver 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:: 3 years
Reported as:: Number · participants

Liver Function Tests
participants	Degarelix 40 mg	Degarelix 80 mg	Degarelix 120 mg	Degarelix 160 mg
Abnormal alanine aminotransferase (ALAT)	0	4	5	6
Abnormal aspartate aminotransferase	1	13	18	9
Abnormal bilirubin	2	0	4	2
ALAT >3x ULN	0	1	0	0
ALAT >3x ULN, bilirubin >1.5x ULN	0	0	0	0

PrimaryParticipants With Markedly Abnormal Change in Vital Signs and Body Weight

Vital signs and body weight 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:: 3 years
Reported as:: Number · participants

Participants With Markedly Abnormal Change in Vital Signs and Body Weight
participants	Degarelix 80 mg	Degarelix 120 mg	Degarelix 160 mg
Diastolic blood pressure <=50 and decrease >=15	1	2	0
Diastolic blood pressure >=105 and increase >=15	0	0	0
Systolic blood pressure <=90 and decrease >=20	3	0	1
Systolic blood pressure >=180 and increase >=20	0	1	0
Heart rate <=50 and decrease >=15	1	2	3
Heart rate >=120 and increase >=15	0	0	0
Body weight decrease of >=7 percent	0	1	0
Body weight increase of >=7 percent	1	6	1

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Degarelix 40 mg	—	—	—
Degarelix 80 mg	—	—	—
Degarelix 120 mg	—	—	—
Degarelix 160 mg	—	—	—

Most frequent serious events

Showing 10 of 20

Most frequent serious events
Event	Degarelix 40 mg	Degarelix 80 mg	Degarelix 120 mg	Degarelix 160 mg
Aortic valve incompetenceCardiac disorders	0/10	0/24	1/24	0/24
BradycardiaCardiac disorders	0/10	0/24	1/24	0/24
Cardiac arrestCardiac disorders	0/10	0/24	1/24	0/24
Coronary artery diseaseCardiac disorders	0/10	1/24	0/24	0/24
Diverticulum intestinal haemorrhagicGastrointestinal disorders	0/10	0/24	0/24	1/24
Inguinal herniaGastrointestinal disorders	0/10	0/24	1/24	0/24
Lobar pneumoniaInfections and infestations	0/10	0/24	1/24	0/24
Hip fractureInjury, poisoning and procedural complications	0/10	1/24	0/24	1/24
Femur fractureInjury, poisoning and procedural complications	0/10	0/24	1/24	0/24
Subdural haematomaInjury, poisoning and procedural complications	0/10	0/24	1/24	0/24

Most frequent other events

Showing 10 of 45

Most frequent other events
Event	Degarelix 40 mg	Degarelix 80 mg	Degarelix 120 mg	Degarelix 160 mg
Hot flushVascular disorders	2/10	14/24	6/24	5/24
AnaemiaBlood and lymphatic system disorders	0/10	2/24	5/24	0/24
ConstipationGastrointestinal disorders	0/10	4/24	2/24	2/24
DiarrhoeaGastrointestinal disorders	0/10	2/24	4/24	0/24
Injection site pruritusGeneral disorders	0/10	4/24	2/24	0/24
GynaecomastiaReproductive system and breast disorders	0/10	4/24	1/24	1/24
HypertensionVascular disorders	0/10	0/24	4/24	0/24
Inguinal herniaGastrointestinal disorders	0/10	3/24	1/24	0/24
Oedema peripheralGeneral disorders	0/10	1/24	3/24	0/24
FatigueGeneral disorders	1/10	3/24	1/24	3/24

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Degarelix 40 mg	Degarelix 80 mg	Degarelix 120 mg	Degarelix 160 mg	Total
<=18 years	0	0	0	0	0
Between 18 and 65 years	1	1	2	4	8
>=65 years	9	23	22	20	74

Age Continuous
Age Continuous(years)	Degarelix 40 mg	Degarelix 80 mg	Degarelix 120 mg	Degarelix 160 mg	Total
Mean	72.0 ± 5.72	77.5 ± 6.38	75.9 ± 5.79	74.7 ± 8.37	75.6 ± 6.90

Sex: Female, Male
Sex: Female, Male(Participants)	Degarelix 40 mg	Degarelix 80 mg	Degarelix 120 mg	Degarelix 160 mg	Total
Female	0	0	0	0	0
Male	10	24	24	24	82

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	Degarelix 40 mg	Degarelix 80 mg	Degarelix 120 mg	Degarelix 160 mg	Total
Black	2	1	2	1	6
Caucasian	5	23	15	20	63
Other	3	0	7	3	13

Gleason score
Gleason score(participants)	Degarelix 40 mg	Degarelix 80 mg	Degarelix 120 mg	Degarelix 160 mg	Total
Unknown	0	1	0	0	1
2-4	1	1	1	0	3
5-6	3	14	12	13	42
7-10	6	8	11	11	36

Stage of prostate cancer
Stage of prostate cancer(participants)	Degarelix 40 mg	Degarelix 80 mg	Degarelix 120 mg	Degarelix 160 mg	Total
Localized	5	11	12	10	38
Locally advanced	0	6	5	5	16
Metastatic	2	4	2	2	10
Not classifiable	3	3	5	7	18

Body mass index
Body mass index(kilogram per square meter)	Degarelix 40 mg	Degarelix 80 mg	Degarelix 120 mg	Degarelix 160 mg	Total
Mean	26.7 ± 5.66	26.6 ± 3.54	27.2 ± 3.15	26.6 ± 3.39	26.8 ± 3.64

Time since prostate cancer diagnosis
Time since prostate cancer diagnosis(days)	Degarelix 40 mg	Degarelix 80 mg	Degarelix 120 mg	Degarelix 160 mg	Total
Mean	851 ± 1077	954 ± 1329	1609 ± 1836	1095 ± 1385	1181 ± 1494

1 further baseline measures are reported on the registry.

Study locations

12 sites

Advanced Urology Medical Center
Anaheim, California 92801, United States
South Orange County Medical Research Center
Laguna Woods,, California 92653, United States
San Bernardino Urological Associates Medical Group
San Bernardino, California 92404, United States
Western Clinical Research
Torrance, California 90505, United States
Urology Associate PC'
Denver, Colorado 80210, United States
SW Florida Urological Associates
Fort Myers, Florida 33907, United States
Pinellas Urology, Inc.
St. Petersburg, Florida 33710, United States
Drs. Werner, Murdock & Francis, PA
Greenbelt, Maryland 20770, United States
Nevada Urology Associates
Reno, Nevada 89511, United States
Urology Specialists of Oklahoma, Inc.
Tulsa, Oklahoma 74104, United States
Urology Clinics of NorthTexas, PA
Dallas, Texas 75231, United States
Urology San Antonio Research
San Antonio, Texas 78229, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 23, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00117312
Lead sponsor: Ferring Pharmaceuticals
First posted: Jul 6, 2005
Start date: Oct 2002
Primary completion: Nov 2005
Completion: Nov 2005
Results posted: Mar 20, 2009
Last update: May 23, 2011

Study contacts

Clinical Development Support

study director · Ferring Pharmaceuticals

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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