Effects of Triptorelin When Given Every 6-months Under the Skin to Adult Males With Cancer in the Prostate

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.