T = testosterone
– Heyns et al, 2003
†At day 253, n=119 for TRELSTAR and n=121 for leuprolide acetate.
STUDY DESIGN
Based on a 9-month, multicenter, parallel-group, double-blind, randomized, controlled clinical trial comparing TRELSTAR 3.75 mg to leuprolide acetate in patients with advanced (stage C/D) prostate cancer (N=284). Mean testosterone levels were calculated for months 2 to 9.
[Refs: TRELSTAR PI, Heyns 2003]
† At day 253, n=119 for TRELSTAR and n=121 for leuprolide acetate.
STUDY DESIGN
3.75 mg: Based on a 9-month, multicenter, parallel-group, double-blind, randomized, controlled clinical trial comparing TRELSTAR 3.75 mg to leuprolide acetate (7.5 mg) in patients with advanced (stage C/D) prostate cancer (N = 284). Mean testosterone levels were calculated for Months 2 to 9. The primary efficacy endpoints were both achievement of castration by Day 29 and maintenance of castration from Day 57 through Day 253.1,2
11.25 mg: In a study of similar design, patients received either TRELSTAR 11.25 mg (N = 174) every 12 weeks for a total of up to 3 doses (maximum treatment period of 253 days) or TRELSTAR 3.75 mg (N = 172) every 28 days for a total of up to 9 doses. The primary efficacy endpoints were both achievement of castration by Day 29 and maintenance of castration from Day 57 through Day 253.1
22.5 mg: In a non-comparative trial, patients received TRELSTAR 22.5 mg (N = 120) every 24 weeks for a total of 2 doses (maximum treatment period of 337 days). The primary efficacy endpoints included achievement of castration by Day 29 and maintenance of castration from Day 57 through Day 337.1
* (≤ 1.735 nmol/L; equivalent to 50 ng/dL)
† Maintenance of castration was calculated using a frequency distribution.
‡ Cumulative maintenance of castration was calculated using a survival analysis (Kaplan-Meier) technique.
TRELSTAR 3.75 mg†
TRELSTAR 11.25 mg†
TRELSTAR 22.5 mg†
TRELSTAR 3.75 mg†
TRELSTAR 11.25 mg†
TRELSTAR 22.5 mg†
*Secondary endpoint.
**22.5 mg at Day 337.
†Mean and median baseline levels were measured on Day 1.
‡Percentage reductions reflect weighted means of each formulation.
Trelstar® and its designs are licensed trademarks of Verity Pharmaceuticals, Inc.
MIXJECT® is a registered trademark of West Pharma. Services IL, Ltd.
Verity Pharmaceuticals, Verity Pharma, and their designs are trademarks of Verity Pharmaceuticals, Inc.
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TSR-072 March 2023
3.75 mg: The most common adverse reactions (≥5%) during TRELSTAR 3.75 mg therapy included hot flushes, skeletal pain, impotence, and headache.
11.25 mg: The most common adverse reactions (≥5%) during TRELSTAR 11.25 mg therapy included hot flushes, skeletal pain, headache, edema in legs, and leg pain.
22.5 mg: The most common adverse reactions (≥5%) during TRELSTAR 22.5 mg therapy included hot flushes, erectile dysfunction, and testicular atrophy.
The 3.75 mg data are based on a 9-month, multicenter, parallel-group, blindly randomized, controlled clinical trial comparing TRELSTAR 3.75 mg to leuprolide acetate in patients with advanced (stage C/D) prostate cancer (N=284). Mean testosterone levels were calculated for months 2 to 9.
The 11.25 mg data are based on a 9-month, multicenter, parallel-group, blindly randomized, controlled clinical trial comparing TRELSTAR 11.25 mg to TRELSTAR 3.75 mg (active comparator) in patients with advanced (stage C/D) prostate cancer (N=284). Mean testosterone levels were calculated for months 2 to 9.
The 22.5 mg data are based on a 12-month, multicenter, open-label, non-comparative phase 3 clinical trial that evaluated the efficacy, pharmacokinetics, and safety of 2 injections of 6-month TRELSTAR 22.5 mg formulation in patients with advanced prostate cancer. Mean testosterone levels were calculated for months 2 to 12.
TRELSTAR can be ordered directly from our national specialty distributor,
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benefits. Call CuraScriptSD® at 877.599.7748.
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TRELSTAR can be ordered directly from our national specialty distributor, AndaMEDS, which provides next business day delivery and other convenient benefits. Call AndaMEDS at 1.855.468.5649, ext.74453.
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