TriangleNCT03085095 · OUTCOME
Testosterone Recovery Rate
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Day 90 follow-up
What was measured
The cumulative probability of testosterone recovery back to \> 280 ng/dL (lower limit of the normal range), back to ≥ 50 ng/dL (definition of castration), and back to \> 280 ng/dL or baseline at 90 days after drug discontinuation was assessed. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.
Analysis population: All randomized participants who received at least 1 dose of study drug and were followed in the testosterone recovery phase.
Groups in this outcome
Relugolix
Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
Leuprolide Acetate
Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
| Group | Source count |
|---|---|
| Relugolix | 622 |
| Leuprolide Acetate | 308 |
Reported measurements
≥ 50 ng/dL
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Relugolix | 93.01 | Not reported | 87.82 | 96.54 | Not reported |
| Leuprolide Acetate | 10.12 | Not reported | 3.84 | 25.24 | Not reported |
> 280 ng/dL
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Relugolix | 53.93 | Not reported | 45.20 | 63.16 | Not reported |
| Leuprolide Acetate | 3.23 | Not reported | 0.46 | 20.77 | Not reported |
> Baseline level or 280 ng/dL
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Relugolix | 54.73 | Not reported | 45.97 | 63.94 | Not reported |
| Leuprolide Acetate | 3.23 | Not reported | 0.46 | 20.77 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 87.82
- upper Limit
- 96.54
- value
- 93.01
- group Id
- OG001
- lower Limit
- 3.84
- upper Limit
- 25.24
- value
- 10.12
- title
- ≥ 50 ng/dL
- categories
- measurements
- group Id
- OG000
- lower Limit
- 45.20
- upper Limit
- 63.16
- value
- 53.93
- group Id
- OG001
- lower Limit
- 0.46
- upper Limit
- 20.77
- value
- 3.23
- title
- > 280 ng/dL
- categories
- measurements
- group Id
- OG000
- lower Limit
- 45.97
- upper Limit
- 63.94
- value
- 54.73
- group Id
- OG001
- lower Limit
- 0.46
- upper Limit
- 20.77
- value
- 3.23
- title
- > Baseline level or 280 ng/dL
- denoms
- counts
- group Id
- OG000
- value
- 622
- group Id
- OG001
- value
- 308
- units
- Participants
- description
- The cumulative probability of testosterone recovery back to \> 280 ng/dL (lower limit of the normal range), back to ≥ 50 ng/dL (definition of castration), and back to \> 280 ng/dL or baseline at 90 days after drug discontinuation was assessed. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
- id
- OG000
- title
- Relugolix
- description
- Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
- id
- OG001
- title
- Leuprolide Acetate
- param Type
- NUMBER
- population Description
- All randomized participants who received at least 1 dose of study drug and were followed in the testosterone recovery phase.
- reporting Status
- POSTED
- time Frame
- Day 90 follow-up
- title
- Testosterone Recovery Rate
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice