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To assess the efficacy and safety of 2 new formulations of leuprolide acetate 45 mg 6-month depot, Formulation A or Formulation B, for the treatment of patients with prostate cancer. A formulation will be deemed successful if the percentage of subjects with suppression of testosterone to <= 50 ng/dL from Week 4 to Week 48 is not less than 87%, (the lower bound of the 2-sided 90% confidence interval), a protocol-specified criterion.
A total of 300 male subjects were planned to be enrolled. Subjects were to receive a total of 2 intramuscular (IM) injections of the same formulation, either Formulation A or Formulation B, administered 24 weeks apart. The first 150 subjects were to receive Formulation A for both injections and the next 150 subjects were to receive Formulation B for both injections. The sponsor was to conduct an ongoing review of the primary endpoint data (suppression of testosterone <= 50 ng/dL) and planned to stop enrollment of Formulation A or Formulation B, or not to administer the second injection of Formulation A or Formulation B, if 15 or more subjects did not achieve testosterone suppression by Week 4 or failed to maintain testosterone suppression during the treatment period.
All analyses and summaries were to be conducted separately for subjects who received Formulation A or Formulation B.
This study was to be conducted at approximately 60-80 investigative sites. Subjects participated in the trial for approximately 14 months.
This trial was to include a Screening Period (up to 4 weeks), a 12-month Treatment Period (two 6-month treatment cycles), and a Follow-Up Period (30 days).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Leuprolide acetate - Formulation A | Experimental | Leuprolide acetate 45 mg, 6-month depot |
|
| Leuprolide acetate - Formulation B | Experimental | Leuprolide acetate, 45 mg, 6-month depot |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leuprolide acetate - Formulation A | Drug | Leuprolide acetate was administered as 2 intramuscular (IM) injections of Formulation A, 45 mg 6 month depot, 24 weeks apart. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Suppression of Serum Testosterone (<=50 ng/dL) From Week 4 to Week 48 for Formulation A: Intent-to-treat (ITT) Population for the Primary Endpoint. | The percentage of subjects with testosterone suppression (<= 50 ng/dL) from Week 4 to Week 48 was calculated by the Kaplan-Meier method for right-censored observations. Subjects who failed testosterone suppression were considered failures on the first day of a testosterone measurement (>50 ng/dL). Subjects who prematurely discontinued without escaping and those who were successfully suppressed through Week 48 were censored at their last measured testosterone value (Day 337 to Day 340 at Week 48). The 90% 2-sided confidence interval was calculated from Kaplan-Meier estimates. | Week 4 to Week 48 |
| Adjusted Percentage of Subjects With Suppression of Serum Testosterone (<=50 ng/dL) From Week 4 to Week 48 for Formulation A: ITT Population for the Primary Endpoint Adjusted | The adjusted percentage of subjects with testosterone suppression (<= 50 ng/dL) from Week 4 to Week 48 was calculated by the Kaplan-Meier method for right-censored observations. The primary efficacy analysis was adjusted to censor subjects who received an anti-androgen at the last testosterone measurement before use of the anti-androgen. One additional subject was censored because of a laboratory error, at the last measurement before the error. The adjusted 90% 2-sided confidence interval was calculated from Kaplan-Meier estimates. | Week 4 to Week 48 |
| Percentage of Subjects With Suppression of Serum Testosterone (<=50 ng/dL) From Week 4 to Week 48 for Formulation B: ITT Population for the Primary Endpoint Preplanned | The percentage of subjects with testosterone suppression (<= 50 ng/dL) from Week 4 to Week 48 was calculated by the Kaplan-Meier method for right-censored observations. Subjects who failed testosterone suppression were considered failures on the first day of a testosterone measurement (>50 ng/dL). Subjects who prematurely discontinued without escaping and those who were successfully suppressed through Week 48 were censored at their last measured testosterone value (Day 337 to Day 340 at Week 48). The 90% 2-sided confidence interval was calculated from Kaplan-Meier estimates. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation A: ITT Population | Baseline was the last measurement before the first dose of Formulation A. The mean +/- standard error was calculated at each visit. The final visit occurred at Week 48 unless the subject prematurely discontinued the study. | Baseline, Days 2 and 8, Weeks 2, 4, 8, 14, 20, 24, 26, 30, 34, 40, 46, 48, and Final Visit |
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Inclusion Criteria:
Voluntarily sign an IRB-approved informed consent form and any required privacy statement/authorization form.
Pre-trial serum testosterone level >150 ng/dL.
Histologically-confirmed prostatic adenocarcinoma in Jewett Clinical Stage A2, B, C or D and TNM* classification cT1b-4, N: any, M: any.
*Tumor/Nodes/Metastases
Subjects with a rising PSA following radical prostatectomy defined as an increase of 0.2 ng/mL from the previous test on two consecutive testings or rising PSA following prostate irradiation using Phoenix Definition of a rise of greater than or equal to 2.0 ng/mL above the nadir.
Prostate cancer and general clinical status is sufficient to warrant at least 48 weeks of continuous androgen deprivation treatment, without concomitant antiandrogen treatment.
Eastern Cooperative Oncology Group (ECOG) Performance status grades 0,1,or 2 at the time of pre-trial screening.
Life expectancy of at least 18 months.
Subjects with serum creatinine ≤1.9 mg/dL, bilirubin ≤2.0 mg/dL (unless Gilbert's syndrome with normal AST, ALT); AST and ALT ≤2.5 times the upper limit of normal.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristof Chwalisz, MD, PhD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 8696 | Birmingham | Alabama | 35209 | United States | ||
| Site Reference ID/Investigator# 8681 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22025196 | Derived | Spitz A, Young JM, Larsen L, Mattia-Goldberg C, Donnelly J, Chwalisz K. Efficacy and safety of leuprolide acetate 6-month depot for suppression of testosterone in patients with prostate cancer. Prostate Cancer Prostatic Dis. 2012 Mar;15(1):93-9. doi: 10.1038/pcan.2011.50. Epub 2011 Oct 25. |
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Formulation A and Formulation B treatment groups were enrolled sequentially. All analyses and summaries were conducted separately for both treatment groups.
The enrollment of subjects with Formulation A occurred sequentially before the enrollment of subjects with Formulation B.
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| ID | Title | Description |
|---|---|---|
| FG000 | Leuprolide Acetate - Formulation A | Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular (IM) injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Leuprolide acetate - Formulation B | Drug | Leuprolide acetate was administered as 2 intramuscular (IM) injections of Formulation B, 45 mg 6 month depot, 24 weeks apart. |
|
|
| Week 4 to Week 48 |
| Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation B: ITT Population | Baseline was the last measurement before the first dose of Formulation B. The mean +/- standard error was calculated at each visit. The final visit occurred at Week 48 unless the subject prematurely discontinued the study. | Baseline, Days 2 and 8, Weeks 2, 4, 8, 14, 20, 24, 26, 30, 34, 40, 46, 48, and Final Visit |
| Mean (+/- Standard Error) Acute-on-chronic Changes in Testosterone From Pre-injection Levels for Formulation A: ITT Population | The acute-on-chronic effect is an agonistic stimulation of serum testosterone after the second depot injection of Formulation A. The mean +/- standard error changes were measured to assess this effect from just before to 2 weeks after the second injection. | Week 24 before the second injection until 2 weeks after Week 24 (2 hours [h], 4 h, 8 h, 1 day [d], 2 d, 3-10 d, and 11-17 d postdose) |
| Mean (+/- Standard Error) Acute-on-chronic Changes in Testosterone From Pre-injection Levels for Formulation B: ITT Population | The acute-on-chronic effect is an agonistic stimulation of serum testosterone after the second depot injection of Formulation B. The mean +/- standard error changes were measured to assess this effect from just before to 2 weeks after the second injection. | Week 24 before the second injection until 2 weeks after Week 24 (2 h, 4 h, 8 h, 1 d, 2 d, 3-10 d, and 11-17 d postdose) |
| Mean (+/- Standard Error) Acute-on-chronic Changes in Luteinizing Hormone From Pre-injection Levels for Formulation A: ITT Population | The acute-on-chronic effect is an agonistic stimulation of luteinizing hormone after the second depot injection of Formulation A. The mean +/- standard error changes were measured to assess this effect from just before to 2 weeks after the second injection. | Week 24 before the second injection until 2 weeks after Week 24 (2 h, 4 h, 8 h, 1 d, 2 d, 3-10 d, and 11-17 d postdose) |
| Mean (+/- Standard Error) Acute-on-chronic Changes in Luteinizing Hormone From Pre-injection Levels for Formulation B: ITT Population | The acute-on-chronic effect is an agonistic stimulation of luteinizing hormone after the second depot injection of Formulation B. The mean +/- standard error changes were measured to assess this effect from just before to 2 weeks after the second injection. | Week 24 before the second injection until 2 weeks after Week 24 (2 h, 4 h, 8 h, 1 d, 2 d, 3-10 d, and 11-17 d postdose) |
| Mean (+/- Standard Error) Prostate Specific Antigen (PSA) at Baseline, Visits Throughout the Study, and at Final Visit for Formulation A: ITT Population | PSA levels were measured at baseline and each treatment visit for Formulation A. The mean (+/- standard error) was calculated at each visit. The final visit occurred at Week 48 unless the subject prematurely discontinued the study. | Baseline, Day 8, Week 14, Week 24, Week 30, Week 40, Week 48, and the Final Visit |
| Mean (+/- Standard Error) Prostate Specific Antigen (PSA) at Baseline, Visits Throughout the Study, and at Final Visit for Formulation B: ITT Population | PSA levels were measured at baseline and each treatment visit for Formulation B. The mean (+/- standard error) was calculated at each visit. The final visit occurred at Week 48 unless the subject prematurely discontinued the study. | Baseline, Day 8, Week 14, Week 24, Week 30, Week 40, Week 48, and the Final Visit |
| Homewood |
| Alabama |
| 35209 |
| United States |
| Site Reference ID/Investigator# 8569 | Anchorage | Alaska | 99508 | United States |
| Site Reference ID/Investigator# 9709 | Phoenix | Arizona | 85013 | United States |
| Site Reference ID/Investigator# 8662 | Sierra Vista | Arizona | 85635 | United States |
| Site Reference ID/Investigator# 8656 | Tucson | Arizona | 85710 | United States |
| Site Reference ID/Investigator# 9705 | Little Rock | Arkansas | 72211 | United States |
| Site Reference ID/Investigator# 8691 | Anaheim | California | 92801 | United States |
| Site Reference ID/Investigator# 8566 | Atherton | California | 94027 | United States |
| Site Reference ID/Investigator# 8686 | Fresno | California | 93720 | United States |
| Site Reference ID/Investigator# 8698 | Laguna Hills | California | 92653 | United States |
| Site Reference ID/Investigator# 9703 | Long Beach | California | 90806 | United States |
| Site Reference ID/Investigator# 8674 | Los Angeles | California | 90015 | United States |
| Site Reference ID/Investigator# 8650 | Tarzana | California | 91356 | United States |
| Site Reference ID/Investigator# 8699 | Torrance | California | 90505 | United States |
| Site Reference ID/Investigator# 8668 | Denver | Colorado | 80211 | United States |
| Site Reference ID/Investigator# 8646 | Englewood | Colorado | 80113 | United States |
| Site Reference ID/Investigator# 8652 | Middlebury | Connecticut | 06762 | United States |
| Site Reference ID/Investigator# 8697 | New Britain | Connecticut | 06052 | United States |
| Site Reference ID/Investigator# 8655 | Aventura | Florida | 33180 | United States |
| Site Reference ID/Investigator# 8648 | Daytona Beach | Florida | 32114 | United States |
| Site Reference ID/Investigator# 8660 | New Smyrna Beach | Florida | 32168 | United States |
| Site Reference ID/Investigator# 8658 | Orange City | Florida | 32763 | United States |
| Site Reference ID/Investigator# 8664 | Orlando | Florida | 32803 | United States |
| Site Reference ID/Investigator# 8651 | Saint Augustine | Florida | 32086 | United States |
| Site Reference ID/Investigator# 8661 | St. Petersburg | Florida | 33710 | United States |
| Site Reference ID/Investigator# 8568 | Tallahassee | Florida | 32308 | United States |
| Site Reference ID/Investigator# 8679 | Wellington | Florida | 33414 | United States |
| Site Reference ID/Investigator# 8562 | West Palm Beach | Florida | 33407 | United States |
| Site Reference ID/Investigator# 8670 | Roswell | Georgia | 30076 | United States |
| Site Reference ID/Investigator# 9708 | Thomasville | Georgia | 31799 | United States |
| Site Reference ID/Investigator# 8693 | Fort Wayne | Indiana | 46825 | United States |
| Site Reference ID/Investigator# 8690 | Newburgh | Indiana | 47630 | United States |
| Site Reference ID/Investigator# 8565 | Overland Park | Kansas | 66211 | United States |
| Site Reference ID/Investigator# 8676 | Greenbelt | Maryland | 20770 | United States |
| Site Reference ID/Investigator# 8653 | Las Vegas | Nevada | 89148 | United States |
| Site Reference ID/Investigator# 8667 | Lawrenceville | New Jersey | 08648 | United States |
| Site Reference ID/Investigator# 8665 | New York | New York | 10016 | United States |
| Site Reference ID/Investigator# 8657 | Poughkeepsie | New York | 12601 | United States |
| Site Reference ID/Investigator# 9702 | The Bronx | New York | 10461 | United States |
| Site Reference ID/Investigator# 8680 | Charlotte | North Carolina | 28209 | United States |
| Site Reference ID/Investigator# 8673 | Concord | North Carolina | 28025 | United States |
| Site Reference ID/Investigator# 8666 | Raleigh | North Carolina | 27607 | United States |
| Site Reference ID/Investigator# 8570 | Salisbury | North Carolina | 28144 | United States |
| Site Reference ID/Investigator# 8644 | Winston-Salem | North Carolina | 27103 | United States |
| Site Reference ID/Investigator# 8663 | Cincinnati | Ohio | 45212 | United States |
| Site Reference ID/Investigator# 8567 | Columbus | Ohio | 43220 | United States |
| Site Reference ID/Investigator# 8678 | Bethany | Oklahoma | 73008 | United States |
| Site Reference ID/Investigator# 8563 | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| Site Reference ID/Investigator# 8692 | Lancaster | Pennsylvania | 17604-3200 | United States |
| Site Reference ID/Investigator# 8689 | Myrtle Beach | South Carolina | 29572 | United States |
| Site Reference ID/Investigator# 8643 | Germantown | Tennessee | 38138 | United States |
| Site Reference ID/Investigator# 8695 | Germantown | Tennessee | 38138 | United States |
| Site Reference ID/Investigator# 8685 | Memphis | Tennessee | 38119 | United States |
| Site Reference ID/Investigator# 8564 | Nashville | Tennessee | 37209 | United States |
| Site Reference ID/Investigator# 8645 | Nashville | Tennessee | 37232-2765 | United States |
| Site Reference ID/Investigator# 8641 | Dallas | Texas | 75231 | United States |
| Site Reference ID/Investigator# 8675 | Houston | Texas | 77024 | United States |
| Site Reference ID/Investigator# 8684 | San Antonio | Texas | 78229 | United States |
| Site Reference ID/Investigator# 8649 | Tyler | Texas | 75701 | United States |
| Site Reference ID/Investigator# 8683 | Salt Lake City | Utah | 84107 | United States |
| Site Reference ID/Investigator# 8672 | Norfolk | Virginia | 23502 | United States |
| Site Reference ID/Investigator# 8669 | Richmond | Virginia | 23235 | United States |
| FG001 |
| Leuprolide Acetate - Formulation B |
Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Leuprolide Acetate - Formulation A | Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular (IM) injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner. |
| BG001 | Leuprolide Acetate - Formulation B | Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects With Suppression of Serum Testosterone (<=50 ng/dL) From Week 4 to Week 48 for Formulation A: Intent-to-treat (ITT) Population for the Primary Endpoint. | The percentage of subjects with testosterone suppression (<= 50 ng/dL) from Week 4 to Week 48 was calculated by the Kaplan-Meier method for right-censored observations. Subjects who failed testosterone suppression were considered failures on the first day of a testosterone measurement (>50 ng/dL). Subjects who prematurely discontinued without escaping and those who were successfully suppressed through Week 48 were censored at their last measured testosterone value (Day 337 to Day 340 at Week 48). The 90% 2-sided confidence interval was calculated from Kaplan-Meier estimates. | The ITT population for the primary endpoint was the same as the ITT population for the secondary endpoints and also excluded subjects whose final testosterone values were measured before Day 19 without suppression (>50 ng/dL) or whose testosterone levels remained suppressed through Week 48 but testosterone levels were not measured at Week 4. | Posted | Number | 90% Confidence Interval | Percent Suppressed | Week 4 to Week 48 |
|
|
| |||||||||||||||||||||||||
| Secondary | Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation A: ITT Population | Baseline was the last measurement before the first dose of Formulation A. The mean +/- standard error was calculated at each visit. The final visit occurred at Week 48 unless the subject prematurely discontinued the study. | The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action. | Posted | Mean | Standard Error | ng/dL | Baseline, Days 2 and 8, Weeks 2, 4, 8, 14, 20, 24, 26, 30, 34, 40, 46, 48, and Final Visit |
|
| ||||||||||||||||||||||||||
| Secondary | Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation B: ITT Population | Baseline was the last measurement before the first dose of Formulation B. The mean +/- standard error was calculated at each visit. The final visit occurred at Week 48 unless the subject prematurely discontinued the study. | The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action. | Posted | Mean | Standard Error | ng/dL | Baseline, Days 2 and 8, Weeks 2, 4, 8, 14, 20, 24, 26, 30, 34, 40, 46, 48, and Final Visit |
|
| ||||||||||||||||||||||||||
| Secondary | Mean (+/- Standard Error) Acute-on-chronic Changes in Testosterone From Pre-injection Levels for Formulation A: ITT Population | The acute-on-chronic effect is an agonistic stimulation of serum testosterone after the second depot injection of Formulation A. The mean +/- standard error changes were measured to assess this effect from just before to 2 weeks after the second injection. | The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action. | Posted | Mean | Standard Error | ng/dL | Week 24 before the second injection until 2 weeks after Week 24 (2 hours [h], 4 h, 8 h, 1 day [d], 2 d, 3-10 d, and 11-17 d postdose) |
|
| ||||||||||||||||||||||||||
| Secondary | Mean (+/- Standard Error) Acute-on-chronic Changes in Testosterone From Pre-injection Levels for Formulation B: ITT Population | The acute-on-chronic effect is an agonistic stimulation of serum testosterone after the second depot injection of Formulation B. The mean +/- standard error changes were measured to assess this effect from just before to 2 weeks after the second injection. | The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action. | Posted | Mean | Standard Error | ng/dL | Week 24 before the second injection until 2 weeks after Week 24 (2 h, 4 h, 8 h, 1 d, 2 d, 3-10 d, and 11-17 d postdose) |
|
| ||||||||||||||||||||||||||
| Primary | Adjusted Percentage of Subjects With Suppression of Serum Testosterone (<=50 ng/dL) From Week 4 to Week 48 for Formulation A: ITT Population for the Primary Endpoint Adjusted | The adjusted percentage of subjects with testosterone suppression (<= 50 ng/dL) from Week 4 to Week 48 was calculated by the Kaplan-Meier method for right-censored observations. The primary efficacy analysis was adjusted to censor subjects who received an anti-androgen at the last testosterone measurement before use of the anti-androgen. One additional subject was censored because of a laboratory error, at the last measurement before the error. The adjusted 90% 2-sided confidence interval was calculated from Kaplan-Meier estimates. | Posted | Number | 90% Confidence Interval | Percent Suppressed | Week 4 to Week 48 |
|
| |||||||||||||||||||||||||||
| Secondary | Mean (+/- Standard Error) Acute-on-chronic Changes in Luteinizing Hormone From Pre-injection Levels for Formulation A: ITT Population | The acute-on-chronic effect is an agonistic stimulation of luteinizing hormone after the second depot injection of Formulation A. The mean +/- standard error changes were measured to assess this effect from just before to 2 weeks after the second injection. | The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action. | Posted | Mean | Standard Error | ng/dL | Week 24 before the second injection until 2 weeks after Week 24 (2 h, 4 h, 8 h, 1 d, 2 d, 3-10 d, and 11-17 d postdose) |
|
| ||||||||||||||||||||||||||
| Secondary | Mean (+/- Standard Error) Acute-on-chronic Changes in Luteinizing Hormone From Pre-injection Levels for Formulation B: ITT Population | The acute-on-chronic effect is an agonistic stimulation of luteinizing hormone after the second depot injection of Formulation B. The mean +/- standard error changes were measured to assess this effect from just before to 2 weeks after the second injection. | The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action. | Posted | Mean | Standard Error | ng/dL | Week 24 before the second injection until 2 weeks after Week 24 (2 h, 4 h, 8 h, 1 d, 2 d, 3-10 d, and 11-17 d postdose) |
|
| ||||||||||||||||||||||||||
| Secondary | Mean (+/- Standard Error) Prostate Specific Antigen (PSA) at Baseline, Visits Throughout the Study, and at Final Visit for Formulation A: ITT Population | PSA levels were measured at baseline and each treatment visit for Formulation A. The mean (+/- standard error) was calculated at each visit. The final visit occurred at Week 48 unless the subject prematurely discontinued the study. | The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action. | Posted | Mean | Standard Error | ng/mL | Baseline, Day 8, Week 14, Week 24, Week 30, Week 40, Week 48, and the Final Visit |
|
| ||||||||||||||||||||||||||
| Secondary | Mean (+/- Standard Error) Prostate Specific Antigen (PSA) at Baseline, Visits Throughout the Study, and at Final Visit for Formulation B: ITT Population | PSA levels were measured at baseline and each treatment visit for Formulation B. The mean (+/- standard error) was calculated at each visit. The final visit occurred at Week 48 unless the subject prematurely discontinued the study. | The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action. | Posted | Mean | Standard Error | ng/mL | Baseline, Day 8, Week 14, Week 24, Week 30, Week 40, Week 48, and the Final Visit |
|
| ||||||||||||||||||||||||||
| Primary | Percentage of Subjects With Suppression of Serum Testosterone (<=50 ng/dL) From Week 4 to Week 48 for Formulation B: ITT Population for the Primary Endpoint Preplanned | The percentage of subjects with testosterone suppression (<= 50 ng/dL) from Week 4 to Week 48 was calculated by the Kaplan-Meier method for right-censored observations. Subjects who failed testosterone suppression were considered failures on the first day of a testosterone measurement (>50 ng/dL). Subjects who prematurely discontinued without escaping and those who were successfully suppressed through Week 48 were censored at their last measured testosterone value (Day 337 to Day 340 at Week 48). The 90% 2-sided confidence interval was calculated from Kaplan-Meier estimates. | The ITT population for the primary endpoint was the same as the ITT population for the secondary endpoints and also excluded subjects whose final testosterone values were measured before Day 19 without suppression (>50 ng/dL) or whose testosterone levels remained suppressed through Week 48 but testosterone levels were not measured at Week 4. | Posted | Number | 90% Confidence Interval | Percent suppressed | Week 4 to Week 48 |
|
Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
This study included 2 treatment groups, Formulation A or Formulation B. Summaries were conducted separately for both treatment groups and no statistical tests were performed between treatment groups.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Leuprolide Acetate - Formulation A | Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular (IM) injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner. | 31 | 151 | 133 | 151 | ||
| EG001 | Leuprolide Acetate - Formulation B | Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner. | 41 | 159 | 127 | 159 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anemia | Blood and lymphatic system disorders | MedDRA 12.0 |
| ||
| acute coronary syndrome | Cardiac disorders | MedDRA 12.0 |
| ||
| angina pectoris | Cardiac disorders | MedDRA 12.0 |
| ||
| angina unstable | Cardiac disorders | MedDRA 12.0 |
| ||
| atrial fibrillation | Cardiac disorders | MedDRA 12.0 |
| ||
| atrioventricular block complete | Cardiac disorders | MedDRA 12.0 |
| ||
| atrioventricular block second degree | Cardiac disorders | MedDRA 12.0 |
| ||
| cardiac failure congestive | Cardiac disorders | MedDRA 12.0 |
| ||
| coronary artery disease | Cardiac disorders | MedDRA 12.0 |
| ||
| sick sinus syndrome | Cardiac disorders | MedDRA 12.0 |
| ||
| iron deficiency anemia | Blood and lymphatic system disorders | MedDRA 12.0 |
| ||
| acute myocardial infarction | Cardiac disorders | MedDRA 12.0 |
| ||
| myocardial infarction | Cardiac disorders | MedDRA 12.0 |
| ||
| palpitations | Cardiac disorders | MedDRA 12.0 |
| ||
| ventricular tachycardia | Cardiac disorders | MedDRA 12.0 |
| ||
| colonic pseudo-obstruction | Gastrointestinal disorders | MedDRA 12.0 |
| ||
| fecaloma | Gastrointestinal disorders | MedDRA 12.0 |
| ||
| intestinal perforation | Gastrointestinal disorders | MedDRA 12.0 |
| ||
| esophageal achalasia | Gastrointestinal disorders | MedDRA 12.0 |
| ||
| pancreatitis | Gastrointestinal disorders | MedDRA 12.0 |
| ||
| pancreatitis acute | Gastrointestinal disorders | MedDRA 12.0 |
| ||
| pneumatosis intestinalis | Gastrointestinal disorders | MedDRA 12.0 |
| ||
| retroperitoneal hemorrhage | Gastrointestinal disorders | MedDRA 12.0 |
| ||
| vomiting | Gastrointestinal disorders | MedDRA 12.0 |
| ||
| asthenia | General disorders | MedDRA 12.0 |
| ||
| chest pain | General disorders | MedDRA 12.0 |
| ||
| multi-organ failure | General disorders | MedDRA 12.0 |
| ||
| cholecystitis | Hepatobiliary disorders | MedDRA 12.0 |
| ||
| acute sinusitis | Infections and infestations | MedDRA 12.0 |
| ||
| bronchiectasis | Infections and infestations | MedDRA 12.0 |
| ||
| bronchitis | Infections and infestations | MedDRA 12.0 |
| ||
| cellulitis | Infections and infestations | MedDRA 12.0 |
| ||
| enterobacter sepsis | Infections and infestations | MedDRA 12.0 |
| ||
| gastroenteritis | Infections and infestations | MedDRA 12.0 |
| ||
| lobar pneumonia | Infections and infestations | MedDRA 12.0 |
| ||
| pneumonia | Infections and infestations | MedDRA 12.0 |
| ||
| septic shock | Infections and infestations | MedDRA 12.0 |
| ||
| urinary tract infection | Infections and infestations | MedDRA 12.0 |
| ||
| urosepsis | Infections and infestations | MedDRA 12.0 |
| ||
| humerus fracture | Injury, poisoning and procedural complications | MedDRA 12.0 |
| ||
| lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 12.0 |
| ||
| in-stent coronary artery restenosis | Injury, poisoning and procedural complications | MedDRA 12.0 |
| ||
| rib fracture | Injury, poisoning and procedural complications | MedDRA 12.0 |
| ||
| lung injury | Injury, poisoning and procedural complications | MedDRA 12.0 |
| ||
| wound dehiscence | Injury, poisoning and procedural complications | MedDRA 12.0 |
| ||
| hyperkalemia | Metabolism and nutrition disorders | MedDRA 12.0 |
| ||
| hypoglycemia | Metabolism and nutrition disorders | MedDRA 12.0 |
| ||
| hypovolemia | Metabolism and nutrition disorders | MedDRA 12.0 |
| ||
| diabetic ketacidosis | Metabolism and nutrition disorders | MedDRA 12.0 |
| ||
| arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 |
| ||
| rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 |
| ||
| B-cell small lymphocytic lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 |
| ||
| bladder cancer stage I, without cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 |
| ||
| bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 |
| ||
| colon cancer stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 |
| ||
| hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 |
| ||
| non-Hodgkin's lymphoma stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 |
| ||
| non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 |
| ||
| prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 |
| ||
| carotid artery stenosis | Nervous system disorders | MedDRA 12.0 |
| ||
| cerebrovascular accident | Nervous system disorders | MedDRA 12.0 |
| ||
| cerebrovascular disorder | Nervous system disorders | MedDRA 12.0 |
| ||
| dementia | Nervous system disorders | MedDRA 12.0 |
| ||
| hemorrhagic transformation stroke | Nervous system disorders | MedDRA 12.0 |
| ||
| presyncope | Nervous system disorders | MedDRA 12.0 |
| ||
| spinal hematoma | Nervous system disorders | MedDRA 12.0 |
| ||
| syncope | Nervous system disorders | MedDRA 12.0 |
| ||
| transient ischemic attack | Nervous system disorders | MedDRA 12.0 |
| ||
| completed suicide | Psychiatric disorders | MedDRA 12.0 |
| ||
| mental status change | Nervous system disorders | MedDRA 12.0 |
| ||
| hematuria | Renal and urinary disorders | MedDRA 12.0 |
| ||
| renal failure acute | Renal and urinary disorders | MedDRA 12.0 |
| ||
| ureteric obstruction | Renal and urinary disorders | MedDRA 12.0 |
| ||
| urinary retention | Renal and urinary disorders | MedDRA 12.0 |
| ||
| chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 |
| ||
| dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 |
| ||
| hemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 |
| ||
| pleural effusion | Renal and urinary disorders | MedDRA 12.0 |
| ||
| pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 |
| ||
| pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 |
| ||
| respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 |
| ||
| aortic aneurysm | Vascular disorders | MedDRA 12.0 |
| ||
| deep vein thrombosis | Vascular disorders | MedDRA 12.0 |
| ||
| hypotension | Vascular disorders | MedDRA 12.0 |
| ||
| orthostatic hypotension | Vascular disorders | MedDRA 12.0 |
| ||
| cholelithiasis | Hepatobiliary disorders | MedDRA 12.0 |
| ||
| hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 12.1 |
| ||
| constipation | Gastrointestinal disorders | MedDRA 12.1 |
| ||
| nausea | Gastrointestinal disorders | MedDRA 12.1 |
| ||
| fatigue | General disorders | MedDRA 12.1 |
| ||
| injection site pain | General disorders | MedDRA 12.1 |
| ||
| edema peripheral | General disorders | MedDRA 12.1 |
| ||
| nasopharyngitis | Infections and infestations | MedDRA 12.1 |
| ||
| upper respiratory tract infection | Infections and infestations | MedDRA 12.1 |
| ||
| urinary tract infection | Infections and infestations | MedDRA 12.1 |
| ||
| arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 |
| ||
| back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 |
| ||
| pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.1 |
| ||
| insomnia | Psychiatric disorders | MedDRA 12.1 |
| ||
| dizziness | Nervous system disorders | MedDRA 12.1 |
| ||
| headache | Nervous system disorders | MedDRA 12.1 |
| ||
| dysuria | Renal and urinary disorders | MedDRA 12.1 |
| ||
| hematuria | Renal and urinary disorders | MedDRA 12.1 |
| ||
| nocturia | Renal and urinary disorders | MedDRA 12.1 |
| ||
| cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 |
| ||
| dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 |
| ||
| hot flush | Vascular disorders | MedDRA 12.1 |
| ||
| hypertension | Vascular disorders | MedDRA 12.1 |
| ||
| musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 |
| ||
| rash | Skin and subcutaneous tissue disorders | MedDRA 12.1 |
|
Treatment with Formulation B was prematurely discontinued as testosterone was not adequately suppressed to <= 50 ng/dL or escapes from suppression occurred. Subjects who had not received dose 2 of Formulation B were discontinued after Week 24.
Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication, whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | Abbott | 800-633-9110 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D016729 | Leuprolide |
| D007987 | Gonadotropin-Releasing Hormone |
| ID | Term |
|---|---|
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
Not provided
Not provided
| >=65 years |
|
| Male |
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|