TriangleNCT00451958 · OUTCOME
Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Until all participants have received at least 5 years of treatment and at a frequency of every 6 months
What was measured
The results below present the percentage of participants of having testosterone \<=0.5 ng/mL at each of the selected time points (there were more time points in the study) from Day 28 in CS21 (NCT00295750) until the end of the CS21A study. In all treatment groups approximately 3% per year of the participants had at least one testosterone \>0.5 ng/mL during the study.
Analysis population: CS21 ITT analysis set i.e. all participants who received at least one dose of degarelix or leuprolide during the mail CS21 study (NCT00295750).
Groups in this outcome
Degarelix 80 mg / Degarelix 80 mg
The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
Degarelix 160 mg / Degarelix 160 mg
The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
Leuprolide 7.5 mg / Degarelix 80 mg
During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
Leuprolide 7.5 mg / Degarelix 160 mg
During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Leuprolide participants who dropped out during the first year (i.e. during CS21) were all attributed to what became the leuprolide 7.5 mg / degarelix 160 mg arm. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
| Group | Source count |
|---|---|
| Degarelix 80 mg / Degarelix 80 mg | 206 |
| Degarelix 160 mg / Degarelix 160 mg | 197 |
| Leuprolide 7.5 mg / Degarelix 80 mg | 69 |
| Leuprolide 7.5 mg / Degarelix 160 mg | 128 |
Reported measurements
Day 84
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Degarelix 80 mg / Degarelix 80 mg | 99.5 | Not reported | 96.5 | 99.9 | Not reported |
| Degarelix 160 mg / Degarelix 160 mg | 100 | Not reported | 100 | 100 | Not reported |
| Leuprolide 7.5 mg / Degarelix 80 mg | 98.6 | Not reported | 90.2 | 99.8 | Not reported |
| Leuprolide 7.5 mg / Degarelix 160 mg | 97.6 | Not reported | 92.7 | 99.2 | Not reported |
Day 364
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Degarelix 80 mg / Degarelix 80 mg | 97.2 | Not reported | 93.5 | 98.8 | Not reported |
| Degarelix 160 mg / Degarelix 160 mg | 98.3 | Not reported | 94.8 | 99.4 | Not reported |
| Leuprolide 7.5 mg / Degarelix 80 mg | 97. | Not reported | 88.9 | 99.3 | Not reported |
| Leuprolide 7.5 mg / Degarelix 160 mg | 96.0 | Not reported | 90.5 | 98.3 | Not reported |
Day 1876
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Degarelix 80 mg / Degarelix 80 mg | 82.0 | Not reported | 72.7 | 88.4 | Not reported |
| Degarelix 160 mg / Degarelix 160 mg | 87.7 | Not reported | 78.0 | 93.3 | Not reported |
| Leuprolide 7.5 mg / Degarelix 80 mg | 84.1 | Not reported | 70.2 | 91.9 | Not reported |
| Leuprolide 7.5 mg / Degarelix 160 mg | 88.4 | Not reported | 75.5 | 94.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 96.5
- upper Limit
- 99.9
- value
- 99.5
- group Id
- OG001
- lower Limit
- 100
- upper Limit
- 100
- value
- 100
- group Id
- OG002
- lower Limit
- 90.2
- upper Limit
- 99.8
- value
- 98.6
- group Id
- OG003
- lower Limit
- 92.7
- upper Limit
- 99.2
- value
- 97.6
- title
- Day 84
- categories
- measurements
- group Id
- OG000
- lower Limit
- 93.5
- upper Limit
- 98.8
- value
- 97.2
- group Id
- OG001
- lower Limit
- 94.8
- upper Limit
- 99.4
- value
- 98.3
- group Id
- OG002
- lower Limit
- 88.9
- upper Limit
- 99.3
- value
- 97.
- group Id
- OG003
- lower Limit
- 90.5
- upper Limit
- 98.3
- value
- 96.0
- title
- Day 364
- categories
- measurements
- group Id
- OG000
- lower Limit
- 72.7
- upper Limit
- 88.4
- value
- 82.0
- group Id
- OG001
- lower Limit
- 78.0
- upper Limit
- 93.3
- value
- 87.7
- group Id
- OG002
- lower Limit
- 70.2
- upper Limit
- 91.9
- value
- 84.1
- group Id
- OG003
- lower Limit
- 75.5
- upper Limit
- 94.7
- value
- 88.4
- title
- Day 1876
- denoms
- counts
- group Id
- OG000
- value
- 206
- group Id
- OG001
- value
- 197
- group Id
- OG002
- value
- 69
- group Id
- OG003
- value
- 128
- units
- Participants
- description
- The results below present the percentage of participants of having testosterone \<=0.5 ng/mL at each of the selected time points (there were more time points in the study) from Day 28 in CS21 (NCT00295750) until the end of the CS21A study. In all treatment groups approximately 3% per year of the participants had at least one testosterone \>0.5 ng/mL during the study.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
- id
- OG000
- title
- Degarelix 80 mg / Degarelix 80 mg
- description
- The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
- id
- OG001
- title
- Degarelix 160 mg / Degarelix 160 mg
- description
- During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
- id
- OG002
- title
- Leuprolide 7.5 mg / Degarelix 80 mg
- description
- During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Leuprolide participants who dropped out during the first year (i.e. during CS21) were all attributed to what became the leuprolide 7.5 mg / degarelix 160 mg arm. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
- id
- OG003
- title
- Leuprolide 7.5 mg / Degarelix 160 mg
- param Type
- NUMBER
- population Description
- CS21 ITT analysis set i.e. all participants who received at least one dose of degarelix or leuprolide during the mail CS21 study (NCT00295750).
- reporting Status
- POSTED
- time Frame
- Until all participants have received at least 5 years of treatment and at a frequency of every 6 months
- title
- Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards
- type
- SECONDARY
- unit Of Measure
- percentage
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice