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CompletedNCT00116779Updated Dec 19, 2011Results posted

A Parallel Group Comparison of the Efficacy and Safety of Degarelix at Two Different Dosing Regimens in Patients With Prostate Cancer

A Phase 2 interventional study of Degarelix in Prostate Cancer, sponsored by Ferring Pharmaceuticals. Completed at 35 sites in 2 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-12-19.

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

Phase
Phase 2
Study type
Interventional
Enrollment
127
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study summary

The purpose of the study was to contribute, along with other such dose-finding studies, to the identification of the most effective treatment regimen for a one month depot injection of degarelix in the treatment of prostate cancer by a rapid and sustained suppression of testosterone.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • Prostate Cancer
  • Androgen ablation therapy
03

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 127 is above 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.

04

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 prior to 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).
  • Histologically confirmed adenocarcinoma of the prostate (all stages), in whom endocrine treatment (except for neoadjuvant hormonal therapy) is indicated. This includes patients with rising PSA after having received radical prostatectomy (removal of the entire prostate and seminal vesicles) or radiotherapy with curative intention.
  • Male patient aged 18 years or over.
  • Has a baseline testosterone above the lower limit of normal range.
  • Has an ECOG (Eastern Co-operative Oncology Group) score equal to or less than 2.
  • Has a PSA value of greater than or equal to 2ng/mL.

Exclusion criteria

Exclusion Criteria:

Any patient meeting one or more of the following exclusion criteria will not be entered into the study.

  • Previous or present hormonal management of prostate cancer (surgical castration or other hormonal manipulation, e.g. GnRH agonists, GnRH antagonists, antiandrogens, estrogens). However, patients having undergone neoadjuvant hormonal therapy in conjunction with prostatectomy or radiotherapy with curative intention may be included so long as the hormonal therapy did not exceed a total duration of 6 months and was terminated at least 6 months prior to the Screening Visit.
  • Currently or recently (within the last 12 weeks preceding the Screening Visit) under treatment with any other drug modifying testosterone level or function.
  • Is considered to be a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 6 months from Screening Visit.
  • Has a history of severe asthma (defined as a need for daily treatment with oral or inhalation steroids to control the asthma), anaphylactic reactions, angioedema, angioneurotic edema or Quincke's Edema.
  • Has hypersensitivity towards any component of the investigational products (degarelix or mannitol).
  • Has history of other cancer within the last 5 years except for prostate cancer and surgically removed basal or squamous cell carcinoma of the skin.
  • Has elevated serum ALT level more than three times above upper level of normal range or serum total bilirubin level above one and a half times above upper level of normal range as measured by the laboratory at the Screening Visit.
  • Has known or suspect hepatic disease of any sort. Patients with liver disease are not to be enrolled in this study.
  • Has other clinically significant laboratory abnormalities, which in the judgment of the investigator would interfere with the participation of the patient in this study or evaluation of study results.
  • Has a clinically significant disorder (other than prostate cancer) 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.
  • Has a mental incapacity or language barriers precluding adequate understanding or cooperation.
  • Has received an investigational drug within the last 12 weeks preceding Screening Visit.
  • Has previously participated in any degarelix study
05

Study design

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

Study arms

  • Experimental
    Degarelix 60mg

    Initial dose of 200 milligrams (40 milligrams per milliliter) of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams (20 milligrams per milliliter) of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.

    Drug: Degarelix

  • Experimental
    Degarelix 80mg

    Initial dose of 200 milligrams (40 milligrams per milliliter) of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams (20 milligrams per milliliter) of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.

    Drug: Degarelix

Interventions

  • DrugDegarelix

    Drug supplied as a powder to be dissolved in the solvent for solution for injection. Maintenance dose given in twelve 28-day cycles.

    Also known as: FE200486

06

What researchers measure

Primary outcomes

  1. Number of Participants With Testosterone <=0.5 Nanogram/Milliliter From Day 28 to Day 364

    Number of participants with all testosterone values \<=0.5 nanogram/milliliter from Day 28 to Day 364

    Time frame: Day 28 to Day 364

  2. Number of Participants With Testosterone Level <= 0.5 Nanogram/Milliliter From Day 28 to Day 364 for Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 28

    Number of participants who maintained a testosterone level of \<=0.5 nanogram/milliliter from Day 28 to Day 364.

    Time frame: Day 28 - Day 364

Secondary outcomes

  1. Number of Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 3.

    Testosterone levels checked at Day 3 to determine if the reduction in testosterone level occurs rapidly after dosing.

    Time frame: Day 3

  2. Days to 50 Percent and 90 Percent Reduction in Prostate-Specific Antigen

    Median number of days after the first dose of Degarelix when the Prostate-Specific Antigen levels fell to 50 percent and 90 percent of the baseline value.

    Time frame: Day 0 (post dose) to Day 364

  3. Days to Prostate-Specific Antigen Progression

    Median days to prostate-specific antigen increase of \>= 50 percent and \>= 5 nanograms/milliliter compared to nadir on two consecutive visits at least 2 weeks apart.

    Time frame: Day 0 (post dose) to Day 364

  4. Median Di-Hydrotestosterone Levels At Various Study Timepoints

    Di-hydrotestosterone levels at baseline and days 1, 3, 7, 14

    Time frame: Baseline, Days 1, 3, 7, 14

  5. Median Prostate-Specific Antigen Values at Various Study Timepoints

    Prostate-specific antigen levels at baseline and days 3, 14, 28, 84, and 364.

    Time frame: Baseline, Days 3, 14, 28, 84, 364

  6. Median Luteinizing Hormone Levels at Various Study Timeframes

    Luteinizing hormone levels at baseline, and days 1, 3, 7, and 14.

    Time frame: Baseline, Days 1, 3, 7, 14

  7. Median Testosterone Levels at Various Days During the Study

    Testosterone levels at baseline and days 1, 3, 7, 14 and 364

    Time frame: Baseline, Days 1,3,7,14,364

  8. Number of Participants With Abnormal Alanine Aminotransferase Values

    Participants whose alanine aminotransferase values were at levels above the normal range.

    Time frame: Day 1 through day 364

  9. Number of Participants With Abnormal Aspartate Aminotransferase Values

    Participants with aspartate aminotransferase values that were above the normal range.

    Time frame: Day 1 - 364

  10. Number of Participants With Abnormal Total Bilirubin Values

    Participants with abnormal total bilirubin values

    Time frame: Day 1 - 364

  11. Participants With Markedly Abnormal Changes in Vital Signs or Body Weight

    Vital sign and body weight values at the end of the trial are compared to baseline values. The table represents the number of participants in each group with normal baseline values and markedly abnormal end-of-study values.

    Time frame: Day 364

07

Results

Posted Mar 20, 2009

Participant flow

Participant flow — Overall Study
MilestoneDegarelix 60mgDegarelix 80mg
Started6364
Completed4245
Not completed2119
Withdrew: Adverse event42
Withdrew: Protocol violation14
Withdrew: Withdrawal by subject41
Withdrew: Inadequate testosterone suppression79
Withdrew: Physician decision31
Withdrew: Elevated psa levels22

Outcome measures

PrimaryNumber of Participants With Testosterone <=0.5 Nanogram/Milliliter From Day 28 to Day 364

Number of participants with all testosterone values \<=0.5 nanogram/milliliter from Day 28 to Day 364

Time frame:
Day 28 to Day 364
Reported as:
Number · participants
Number of Participants With Testosterone <=0.5 Nanogram/Milliliter From Day 28 to Day 364
participantsDegarelix 60mgDegarelix 80mg
Number of Participants With Testosterone <=0.5 Nanogram/Milliliter From Day 28 to Day 36442 (73 to 94)41 (64 to 88)
Statistical analysis
  • Degarelix 60mg · Percentage of participants: 86 · 95% CI 73 to 94The 95% confidence interval was calculated by Clopper-Pearson method.
  • Degarelix 80mg · Percentage of participants: 77 · 95% CI 64 to 88The 95% confidence interval was calculated by Clopper-Pearson method.
SecondaryNumber of Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 3.

Testosterone levels checked at Day 3 to determine if the reduction in testosterone level occurs rapidly after dosing.

Time frame:
Day 3
Reported as:
Number · participants
Number of Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 3.
participantsDegarelix 60mgDegarelix 80mg
Number of Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 3.54 (79 to 96)56 (78 to 95)
Statistical analysis
  • Degarelix 60mg · Percentage of participants: 90 · 95% CI 79 to 96The 95% confidence interval was calculated by Clopper-Pearson method.
  • Degarelix 80mg · Percentage of participants: 89 · 95% CI 78 to 95The 95% confidence interval was calculated by Clopper-Pearson method.
  • Degarelix 60mg vs Degarelix 80mg · Chi-squared · p = 0.8413
PrimaryNumber of Participants With Testosterone Level <= 0.5 Nanogram/Milliliter From Day 28 to Day 364 for Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 28

Number of participants who maintained a testosterone level of \<=0.5 nanogram/milliliter from Day 28 to Day 364.

Time frame:
Day 28 - Day 364
Reported as:
Number · participants
Number of Participants With Testosterone Level <= 0.5 Nanogram/Milliliter From Day 28 to Day 364 for Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 28
participantsDegarelix 60mgDegarelix 80mg
Number of Participants With Testosterone Level <= 0.5 Nanogram/Milliliter From Day 28 to Day 364 for Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 2842 (82 to 99)41 (87 to 100)
Statistical analysis
  • Degarelix 60mg · Percentage of participants: 93 · 95% CI 82 to 99The 95% confidence interval was calculated by Clopper-Pearson method.
  • Degarelix 80mg · Percentage of participants: 98 · 95% CI 87 to 100The 95% confidence interval was calculated by Clopper-Pearson method.
SecondaryDays to 50 Percent and 90 Percent Reduction in Prostate-Specific Antigen

Median number of days after the first dose of Degarelix when the Prostate-Specific Antigen levels fell to 50 percent and 90 percent of the baseline value.

Time frame:
Day 0 (post dose) to Day 364
Reported as:
Median · days
Days to 50 Percent and 90 Percent Reduction in Prostate-Specific Antigen
daysDegarelix 60mgDegarelix 80mg
50 percent reduction (n=59, 59)14 (3 to 84)14 (1 to 56)
90 percent reduction (n=45, 48)56 (28 to 168)56 (14 to 252)
Statistical analysis
  • Degarelix 60mg vs Degarelix 80mg · Log Rank · p = .904
  • Degarelix 60mg vs Degarelix 80mg · Log Rank · p = .778
SecondaryDays to Prostate-Specific Antigen Progression

Median days to prostate-specific antigen increase of \>= 50 percent and \>= 5 nanograms/milliliter compared to nadir on two consecutive visits at least 2 weeks apart.

Time frame:
Day 0 (post dose) to Day 364
Reported as:
Median · days
Days to Prostate-Specific Antigen Progression
daysDegarelix 60mgDegarelix 80mg
Days to Prostate-Specific Antigen Progression196 (107 to 280)154 (28 to 308)
SecondaryMedian Di-Hydrotestosterone Levels At Various Study Timepoints

Di-hydrotestosterone levels at baseline and days 1, 3, 7, 14

Time frame:
Baseline, Days 1, 3, 7, 14
Reported as:
Median · picogram / milliliter
Median Di-Hydrotestosterone Levels At Various Study Timepoints
picogram / milliliterDegarelix 60mgDegarelix 80mg
Baseline (n=63, 64)360 (10 to 800)350 (48 to 810)
Day 1 (n=62, 62)110 (37 to 350)120 (34 to 280)
Day 3 (n=58, 63)56.5 (10 to 230)57 (10 to 150)
Day 7 (n=58, 63)45.5 (20 to 150)52 (10 to 280)
Day 14 (n=61, 61)37 (10 to 230)40 (10 to 430)
SecondaryMedian Prostate-Specific Antigen Values at Various Study Timepoints

Prostate-specific antigen levels at baseline and days 3, 14, 28, 84, and 364.

Time frame:
Baseline, Days 3, 14, 28, 84, 364
Reported as:
Median · nanogram / milliliter
Median Prostate-Specific Antigen Values at Various Study Timepoints
nanogram / milliliterDegarelix 60mgDegarelix 80mg
Baseline (n=63, 64)12.7 (2.7 to 759)13.7 (1.6 to 1942)
Day 3 (n=60, 64)11.4 (2.1 to 1557)12.2 (1.3 to 1206)
Day 14 (n=61, 63)6.4 (0.9 to 362)6.8 (0.9 to 182)
Day 28 (n=61, 63)2.9 (0.3 to 28.8)3.6 (0.3 to 127)
Day 84 (n=57, 54)0.8 (0 to 32.1)0.7 (0 to 104)
Day 364 (n=42, 43)0.4 (0 to 12.8)0.2 (0 to 39.8)
SecondaryMedian Luteinizing Hormone Levels at Various Study Timeframes

Luteinizing hormone levels at baseline, and days 1, 3, 7, and 14.

Time frame:
Baseline, Days 1, 3, 7, 14
Reported as:
Median · international units / liter
Median Luteinizing Hormone Levels at Various Study Timeframes
international units / literDegarelix 60mgDegarelix 80mg
Baseline (n=63, 64)5.28 (1.22 to 25)5.33 (0.72 to 31)
Day 1 (n=58, 61)0.915 (0.22 to 5.21)0.87 (0.035 to 5.64)
Day 3 (n=59, 60)0.43 (0.035 to 2.05)0.425 (0.035 to 1.78)
Day 7 (n=60, 61)0.41 (0.035 to 2.64)0.6 (0.035 to 7.35)
Day 14 (n=61, 62)0.2 (0.035 to 3.5)0.37 (0.035 to 9.5)
SecondaryMedian Testosterone Levels at Various Days During the Study

Testosterone levels at baseline and days 1, 3, 7, 14 and 364

Time frame:
Baseline, Days 1,3,7,14,364
Reported as:
Median · nanograms / milliliter
Median Testosterone Levels at Various Days During the Study
nanograms / milliliterDegarelix 60mgDegarelix 80mg
Baseline (n=63, 64)4.1 (1.51 to 11)4.23 (0.2 to 8.68)
Day 1 (n=61, 63)0.56 (0.2 to 2.49)0.71 (0.12 to 2.98)
Day 3 (n=60, 63)0.26 (0.13 to 0.67)0.31 (0.11 to 1.31)
Day 7 (n=60, 64)0.18 (0.08 to 1.46)0.24 (0.07 to 3.98)
Day 14 (n=61, 63)0.11 (0.04 to 2.19)0.14 (0.015 to 6.99)
Day 364 (n=42, 43)0.07 (0.015 to 0.45)0.07 (0.015 to 0.32)
SecondaryNumber of Participants With Abnormal Alanine Aminotransferase Values

Participants whose alanine aminotransferase values were at levels above the normal range.

Time frame:
Day 1 through day 364
Reported as:
Number · participants
Number of Participants With Abnormal Alanine Aminotransferase Values
participantsDegarelix 60mgDegarelix 80mg
> upper limit and 3 times upper limit1021
Total abnormal (> upper limit)1021
Total normal (<=upper limit)5243
SecondaryNumber of Participants With Abnormal Aspartate Aminotransferase Values

Participants with aspartate aminotransferase values that were above the normal range.

Time frame:
Day 1 - 364
Reported as:
Number · participants
Number of Participants With Abnormal Aspartate Aminotransferase Values
participantsDegarelix 60mgDegarelix 80mg
> 3 times upper limit - 5 times upper limit01
> upper limit - 3 times upper limit65
Total Abnormal (> upper limit)66
Total Normal (<= upper limit)5658
SecondaryNumber of Participants With Abnormal Total Bilirubin Values

Participants with abnormal total bilirubin values

Time frame:
Day 1 - 364
Reported as:
Number · participants
Number of Participants With Abnormal Total Bilirubin Values
participantsDegarelix 60mgDegarelix 80mg
>2 times upper limit01
>1.5 times upper limit24
> upper limit - 1.5 times upper limit129
Total abnormal (> upper limit)1414
Total normal (<=upper limit)4850
SecondaryParticipants With Markedly Abnormal Changes in Vital Signs or Body Weight

Vital sign and body weight values at the end of the trial are compared to baseline values. The table represents the number of participants in each group with normal baseline values and markedly abnormal end-of-study values.

Time frame:
Day 364
Reported as:
Number · participants
Participants With Markedly Abnormal Changes in Vital Signs or Body Weight
participantsDegarelix 60mgDegarelix 80mg
Diastolic blood pressure <= 50 and decrease >= 1575
Diastolic blood pressure >= 105 and increase >= 1512
Pulse <=50 and decrease of >=1525
Pulse >=120 and increase of >=1500
Systolic blood pressure <=90 and decrease >=2055
Systolic blood pressure >=180 and increase >=2067
Weight decrease of >=7 percent23
Weight increase of >= 7 percent74

Adverse events

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

Adverse event summary by group
GroupDeathsSeriousOther
Degarelix 60mg———
Degarelix 80mg———
Most frequent serious events
Showing 10 of 19
Most frequent serious events
EventDegarelix 60mgDegarelix 80mg
Myocardial infarctionCardiac disorders1/631/64
Acute coronary syndromeCardiac disorders1/630/64
ConstipationGastrointestinal disorders1/630/64
Injection site urticariaGeneral disorders1/630/64
PneumoniaInfections and infestations1/631/64
OrchitisInfections and infestations1/630/64
Perirectal abscessInfections and infestations1/630/64
Pseudomembranous colitisInfections and infestations1/630/64
Gastroenteritis radiationInjury, poisoning and procedural complications1/630/64
ArthralgiaMusculoskeletal and connective tissue disorders1/630/64
Most frequent other events
Showing 10 of 29
Most frequent other events
EventDegarelix 60mgDegarelix 80mg
Hot flushVascular disorders24/6331/64
FatigueGeneral disorders10/6315/64
NasopharyngitisInfections and infestations7/637/64
DizzinessNervous system disorders7/636/64
NocturiaRenal and urinary disorders1/637/64
Erectile dysfunctionReproductive system and breast disorders4/636/64
Injection site painGeneral disorders4/635/64
Upper respiratory tract infectionInfections and infestations1/635/64
Back painMusculoskeletal and connective tissue disorders2/635/64
InsomniaPsychiatric disorders2/635/64

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Degarelix 60mgDegarelix 80mgTotal
<=18 years000
Between 18 and 65 years9918
>=65 years5455109
Age Continuous
Age Continuous(years)Degarelix 60mgDegarelix 80mgTotal
Mean74.8 ± 8.7374.9 ± 9.5574.9 ± 9.12
Sex: Female, Male
Sex: Female, Male(Participants)Degarelix 60mgDegarelix 80mgTotal
Female000
Male6364127
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Degarelix 60mgDegarelix 80mgTotal
American Indian or Alaska Native000
Asian112
Native Hawaiian or Other Pacific Islander000
Black or African American14418
White4859107
More than one race000
Unknown or Not Reported000
Curative Intent
Curative Intent(participants)Degarelix 60mgDegarelix 80mgTotal
No414081
Yes222446
Participant Counts by Gleason Score
Participant Counts by Gleason Score(participants)Degarelix 60mgDegarelix 80mgTotal
2-4336
5-6192241
7-10413980
The Number of Participants at Each Stage of Prostate Cancer
The Number of Participants at Each Stage of Prostate Cancer(participants)Degarelix 60mgDegarelix 80mgTotal
Localized312354
Locally advanced5914
Metastatic15924
Not classifiable122335
Body Mass Index
Body Mass Index(kilogram per square meter)Degarelix 60mgDegarelix 80mgTotal
Mean27.3 ± 4.126.7 ± 3.9827 ± 4.03

4 further baseline measures are reported on the registry.

08

Study locations

35 sites
  • Urology Centers of Alabama
    Homewood, Alabama 35209, United States
  • Alaska Clinical Research Center, LLC
    Anchorage, Alaska 99508, United States
  • Advanced Urology Medical Center
    Anaheim, California 92801, United States
  • South Orange County Medical Research Cnter
    Laguna Woods,, California 92653, United States
  • Pacific Clinical Research
    Santa Monica, California 90404, United States
  • West Coast Clinical Research
    Tarzana, California 91356, United States
  • Western Clinical Research
    Torrance, California 90505, United States
  • Urology Associate PC
    Denver, Colorado 80210, United States
  • South Florida Medical Research
    Aventura, Florida 33180, United States
  • SW Florida Urological Associates
    Fort Myers, Florida 33907, United States
  • Florida Foundation for Healthcare Research
    Ocala, Florida 34474, United States
  • RMD Clinical Reseach Institution LLC
    Melrose Park, Illinois 60160, United States
  • Northeast Indiana Research, LLC
    Fort Wayne, Indiana 46825, United States
  • Regional Urology
    Shreveport, Louisiana 71106, United States
  • Nevada Urology Associates
    Reno, Nevada 89511, United States
  • Lawrenceville Urology
    Lawrenceville, New Jersey 08648, United States
  • Hudson Valley Urology PC
    Poughkeepsie, New York 12601, United States
  • The Urology Center
    Greensboro, North Carolina 27401, United States
  • State College Urologic Association
    State College, Pennsylvania 16801, United States
  • Univeristy Urological Research Institute
    Providence, Rhode Island 02904, United States
  • Urology San Antonio Research
    San Antonio, Texas 78229, United States
  • Scott & White Memorial Hospital
    Temple, Texas 76508, United States
  • University of Vermont, Dept of Surgery
    South Burlington, Vermont 05403, United States
  • Virginia Urology Center
    Richmond, Virginia 23235, United States
  • Office of Jeffrey Frankel
    Seattle, Washington 98166, United States
  • Wyoming Research Foundation
    Cheyenne, Wyoming 82001, United States
  • Southern Interior Medical Research Corporation
    Kelowna, British Columbia V1Y2H4, Canada
  • Dr. Cal Abdreau Research
    Surrey, British Columbia V3V1N1, Canada
  • Can-Med Clinical Research, Inc.
    Victoria, British Columbia V8T5G1, Canada
  • Dr. Gary Steinhoff Clinical Research
    Victoria, British Columbia V8V3N1, Canada
  • Valley Professional Center
    Kentville, Nova Scotia B4N4K9, Canada
  • The Male and Female Health and Research Centers
    Barrie, Ontario L4M7G1, Canada
  • Brantford Urology Research
    Brantford, Ontario N3R4N3, Canada
  • Burlington Professional Care
    Burlington, Ontario L7N3V2, Canada
  • The Female/Male Health Centres
    Oakville, Ontario L6H3P1, Canada
09

References and documents

Publications

  • Gittelman M, Pommerville PJ, Persson BE, Jensen JK, Olesen TK; Degarelix Study Group. A 1-year, open label, randomized phase II dose finding study of degarelix for the treatment of prostate cancer in North America. J Urol. 2008 Nov;180(5):1986-92. doi: 10.1016/j.juro.2008.07.033. Epub 2008 Sep 17. PubMed 18801505 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00116779
Lead sponsor
Ferring Pharmaceuticals
Responsible party
Sponsor
First posted
Jul 1, 2005
Start date
Feb 2004
Primary completion
Aug 2005
Completion
Aug 2005
Results posted
Mar 20, 2009
Last update
Dec 19, 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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