Percentage of Participants Who Maintained Castrate Levels of Serum Testosterone During the Study
| Group | Value (percentage of participants) |
|---|---|
| Triptorelin Embonate 22.5 mg | 95.0 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataShort name TriptoSwitch
Belgium, Czechia, France, Germany, Lithuania, Netherlands, Spain
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The aim of the study is to determine if triptorelin formulated for use every 6 months (given twice during the study) is effective and safe for when given by injection under the skin for the treatment of adult males with cancer in the prostate.
Experimental
Triptorelin embonate
All participants will receive triptorelin embonate 22.5 mg
Outcomes the sponsor listed as primary.
Percentage of Participants Who Maintained Castrate Levels of Serum Testosterone During the Study
Time frame · Up to Day 337
Blood samples were collected for the measurement of serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry method. Maintenance of castration during the study was defined as testosterone \<1.735 nanomoles per liter (nmol/L) (\<50 nanograms/deciliter \[ng/dL\]) at Days 29, 85, 141, 169, 253, 309 and 337.
Percentage of Participants Castrated on Days 29, 85, 141, 169, 253, 309 and 337
Time frame · Days 29, 85, 141, 169, 253, 309 and 337
Blood samples were collected for the measurement of serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry method. Castration was defined as testosterone \<1.735 nmol/L (\<50 ng/dL).
Percentage of Participants With a Serum Testosterone Level <0.694 Nmol/L (<20 ng/dL) During the Study
Time frame · Up to Day 337
Blood samples were collected for the measurement of serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry method.
Percentage of Participants With a Serum Testosterone Level <0.694 Nmol/L (<20 ng/dL) on Days 29, 85, 141, 169, 253, 309 and 337
Time frame · Days 29, 85, 141, 169, 253, 309 and 337
Blood samples were collected for the measurement of serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry method.
Percentage of Participants Castrated on Days 3 and 7 After Each Injection Administered on Days 1 and 169
Time frame · On Days 3, 7, 171, and 175
Blood samples were collected for the measurement of serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry method. Castration was defined as testosterone \<1.735 nmol/L (\<50 ng/dL).
Percent Change From Baseline in Prostate Specific Antigen (PSA) at Days 169 and 337
Time frame · Baseline (prior to injection on Day 1), Days 169 and 337
Blood samples were collected for the measurement of plasma PSA concentrations. Percent change in PSA was defined as the absolute value of the difference between the PSA values at Days 169 and 337 and the baseline value divided by the baseline value. The baseline value was the last sample prior to the first injection.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and TEAEs of Local Intolerance
Time frame · From first dose of study treatment (Day 1) up to end of study visit (Day 337)
An adverse event (AE) was any untoward medical occurrence in clinical study participant, temporally associated with use of study treatment, whether or not considered related to study treatment. TEAEs were AEs that started or worsened on or after the first study treatment administration and within 168 days after the last dose of study treatment, or up to Day 337, whichever was later. Local tolerance was assessed 2 hours after each injection by examination of injection site for signs such as but not limited to tenderness, redness, bruising, erythema, swelling, rash, pain, itching, induration, hematoma, ulceration or necrosis.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percentage of participants) |
|---|---|
| Triptorelin Embonate 22.5 mg | 95.0 |
| Group | Value (percentage of participants) |
|---|---|
| Triptorelin Embonate 22.5 mg | 100.0 |
| Group | Value (percentage of participants) |
|---|---|
| Triptorelin Embonate 22.5 mg | 83.3 |
| Group | Value (percentage of participants) |
|---|---|
| Triptorelin Embonate 22.5 mg | 92.5 |
| Group | Value (percentage of participants) |
|---|---|
| Triptorelin Embonate 22.5 mg | 92.5 |
| Group | Value (percent change) |
|---|---|
| Triptorelin Embonate 22.5 mg | 0.00 |
| Group | Value (Participants) |
|---|---|
| Triptorelin Embonate 22.5 mg | 88 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Triptorelin Embonate 22.5 mgParticipants received triptorelin embonate 22.5 mg SC injection on Days 1 and 169. | 4 / 145 | 26 / 145 | 38 / 145 |
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