Number of Participants With Testosterone <=0.5 Nanogram/Milliliter From Day 28 to Day 364
| Group | Value (participants) |
|---|---|
| Degarelix 60mg | 42 |
| Degarelix 80mg | 41 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States, Canada
1 trial · 1 completed · 1 with posted results
A Parallel Group Comparison of the Efficacy and Safety of Degarelix at Two Different Dosing Regimens in Patients With Prostate Cancer
NCT00116779Feb 2004 to Aug 2005
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
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.
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.
Outcomes the sponsor listed as primary.
Number of Participants With Testosterone <=0.5 Nanogram/Milliliter From Day 28 to Day 364
Time frame · Day 28 to Day 364
Number of participants with all testosterone values \<=0.5 nanogram/milliliter from Day 28 to Day 364
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
Time frame · Day 28 - Day 364
Number of participants who maintained a testosterone level of \<=0.5 nanogram/milliliter from Day 28 to Day 364.
Number of Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 3.
Time frame · Day 3
Testosterone levels checked at Day 3 to determine if the reduction in testosterone level occurs rapidly after dosing.
Days to 50 Percent and 90 Percent Reduction in Prostate-Specific Antigen
Time frame · Day 0 (post dose) to Day 364
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.
Days to Prostate-Specific Antigen Progression
Time frame · Day 0 (post dose) to Day 364
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.
Median Di-Hydrotestosterone Levels At Various Study Timepoints
Time frame · Baseline, Days 1, 3, 7, 14
Di-hydrotestosterone levels at baseline and days 1, 3, 7, 14
Median Prostate-Specific Antigen Values at Various Study Timepoints
Time frame · Baseline, Days 3, 14, 28, 84, 364
Prostate-specific antigen levels at baseline and days 3, 14, 28, 84, and 364.
Median Luteinizing Hormone Levels at Various Study Timeframes
Time frame · Baseline, Days 1, 3, 7, 14
Luteinizing hormone levels at baseline, and days 1, 3, 7, and 14.
Median Testosterone Levels at Various Days During the Study
Time frame · Baseline, Days 1,3,7,14,364
Testosterone levels at baseline and days 1, 3, 7, 14 and 364
Number of Participants With Abnormal Alanine Aminotransferase Values
Time frame · Day 1 through day 364
Participants whose alanine aminotransferase values were at levels above the normal range.
Number of Participants With Abnormal Aspartate Aminotransferase Values
Time frame · Day 1 - 364
Participants with aspartate aminotransferase values that were above the normal range.
Number of Participants With Abnormal Total Bilirubin Values
Time frame · Day 1 - 364
Participants with abnormal total bilirubin values
Participants With Markedly Abnormal Changes in Vital Signs or Body Weight
Time frame · Day 364
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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (participants) |
|---|---|
| Degarelix 60mg | 42 |
| Degarelix 80mg | 41 |
| Group | Value (participants) |
|---|---|
| Degarelix 60mg | 42 |
| Degarelix 80mg | 41 |
| Group | Value (participants) |
|---|---|
| Degarelix 60mg | 54 |
| Degarelix 80mg | 56 |
| Group | Value (days) |
|---|---|
| Degarelix 60mg | 14 |
| Degarelix 80mg | 14 |
| Group | Value (days) |
|---|---|
| Degarelix 60mg | 196 |
| Degarelix 80mg | 154 |
| Group | Value (picogram / milliliter) |
|---|---|
| Degarelix 60mg | 360 |
| Degarelix 80mg | 350 |
| Group | Value (nanogram / milliliter) |
|---|---|
| Degarelix 60mg | 12.7 |
| Degarelix 80mg | 13.7 |
| Group | Value (international units / liter) |
|---|---|
| Degarelix 60mg | 5.28 |
| Degarelix 80mg | 5.33 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Degarelix 60mgInitial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13. | – | 9 / ? | 55 / ? |
| Degarelix 80mgInitial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13. | – | 6 / ? | 52 / ? |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
1 study on this page
Indexing hint: Randomized controlled trial · 2008
Gittelman et al. 2008The Journal of urologycited by 67
PMID 18801505DOI 10.1016/j.juro.2008.07.033PUB-18801505
Who could join, as posted.
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