Trial · NCT00626431
A Study of Leuprolide to Treat Prostate Cancer
NCT00626431, Phase 3, Completed, Abbott; results first posted 2010-11-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Leuprolide to Treat Prostate Cancer. Trials, record NCT00626431. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00626431
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Leuprolide to Treat Prostate Cancer
- NCT number
- NCT00626431
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 310 participants, actual
- Lead sponsor
- Abbott
- Conditions
- Prostate Cancer
- Interventions
- Leuprolide acetate - Formulation A, Leuprolide acetate - Formulation B
- First posted
- 2008-02-29
- Last updated
- 2011-07-19
- Results first posted
- 2010-11-01
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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. | Week 4 to Week 48 | 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. |
| 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 | Week 4 to Week 48 | 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. |
| 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 | Week 4 to Week 48 | 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. |
| Secondary | Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation A: ITT Population | Baseline, Days 2 and 8, Weeks 2, 4, 8, 14, 20, 24, 26, 30, 34, 40, 46, 48, and Final Visit | 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. |
| Secondary | Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation B: ITT Population | Baseline, Days 2 and 8, Weeks 2, 4, 8, 14, 20, 24, 26, 30, 34, 40, 46, 48, and Final Visit | 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. |
| Secondary | Mean (+/- Standard Error) Acute-on-chronic Changes in Testosterone From Pre-injection Levels for Formulation A: ITT Population | 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) | 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. |
| Secondary | Mean (+/- Standard Error) Acute-on-chronic Changes in Testosterone From Pre-injection Levels for Formulation B: ITT Population | 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) | 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. |
| Secondary | Mean (+/- Standard Error) Acute-on-chronic Changes in Luteinizing Hormone From Pre-injection Levels for Formulation A: ITT Population | 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) | 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. |
| Secondary | Mean (+/- Standard Error) Acute-on-chronic Changes in Luteinizing Hormone From Pre-injection Levels for Formulation B: ITT Population | 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) | 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. |
| Secondary | Mean (+/- Standard Error) Prostate Specific Antigen (PSA) at Baseline, Visits Throughout the Study, and at Final Visit for Formulation A: ITT Population | Baseline, Day 8, Week 14, Week 24, Week 30, Week 40, Week 48, and the Final Visit | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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. | Week 4 to Week 48 | 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. | Percent Suppressed | NUMBER |
| SECONDARY | Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation A: ITT Population | Baseline, Days 2 and 8, Weeks 2, 4, 8, 14, 20, 24, 26, 30, 34, 40, 46, 48, and Final Visit | 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. | ng/dL | MEAN |
| SECONDARY | Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation B: ITT Population | Baseline, Days 2 and 8, Weeks 2, 4, 8, 14, 20, 24, 26, 30, 34, 40, 46, 48, and Final Visit | 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. | ng/dL | MEAN |
| SECONDARY | Mean (+/- Standard Error) Acute-on-chronic Changes in Testosterone From Pre-injection Levels for Formulation A: ITT Population | 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) | 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. | ng/dL | MEAN |
| SECONDARY | Mean (+/- Standard Error) Acute-on-chronic Changes in Testosterone From Pre-injection Levels for Formulation B: ITT Population | 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) | 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. | ng/dL | MEAN |
| 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 | Week 4 to Week 48 | Percent Suppressed | NUMBER | |
| SECONDARY | Mean (+/- Standard Error) Acute-on-chronic Changes in Luteinizing Hormone From Pre-injection Levels for Formulation A: ITT Population | 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) | 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. | ng/dL | MEAN |
| SECONDARY | Mean (+/- Standard Error) Acute-on-chronic Changes in Luteinizing Hormone From Pre-injection Levels for Formulation B: ITT Population | 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) | 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. | ng/dL | MEAN |
| SECONDARY | Mean (+/- Standard Error) Prostate Specific Antigen (PSA) at Baseline, Visits Throughout the Study, and at Final Visit for Formulation A: ITT Population | Baseline, Day 8, Week 14, Week 24, Week 30, Week 40, Week 48, and the Final Visit | 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. | ng/mL | MEAN |
| SECONDARY | Mean (+/- Standard Error) Prostate Specific Antigen (PSA) at Baseline, Visits Throughout the Study, and at Final Visit for Formulation B: ITT Population | Baseline, Day 8, Week 14, Week 24, Week 30, Week 40, Week 48, and the Final Visit | 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. | ng/mL | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group75
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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. | Leuprolide Acetate - Formulation A | 93.6 | 90% Confidence Interval 2.05 | Percent Suppressed | |
| Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation A: ITT Population | Leuprolide Acetate - Formulation A | Testosterone concentration at baseline | 432.9 | Standard Error 14.35 | ng/dL |
| Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation A: ITT Population | Leuprolide Acetate - Formulation A | Testosterone concentration at Day 2 | 613.1 | Standard Error 21.53 | ng/dL |
| Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation A: ITT Population | Leuprolide Acetate - Formulation A | Testosterone concentration at Day 8 | 468.2 | Standard Error 16.55 | ng/dL |
| Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation A: ITT Population | Leuprolide Acetate - Formulation A | Testosterone concentration at Week 2 | 127.1 | Standard Error 7.36 | ng/dL |
| Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation A: ITT Population | Leuprolide Acetate - Formulation A | Testosterone concentration at Week 4 | 16.0 | Standard Error 0.70 | ng/dL |
| Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation A: ITT Population | Leuprolide Acetate - Formulation A | Testosterone concentration at Week 8 | 9.6 | Standard Error 0.46 | ng/dL |
| Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation A: ITT Population | Leuprolide Acetate - Formulation A | Testosterone concentration at Week 14 | 9.2 | Standard Error 0.46 | ng/dL |
| Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation A: ITT Population | Leuprolide Acetate - Formulation A | Testosterone concentration at Week 20 | 8.5 | Standard Error 0.46 | ng/dL |
| Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation A: ITT Population | Leuprolide Acetate - Formulation A | Testosterone concentration at Week 24 | 14.3 | Standard Error 1.25 | ng/dL |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Leuprolide Acetate - Formulation A | 151 | |
| Overall Study | STARTED | Leuprolide Acetate - Formulation B | 159 | |
| Overall Study | COMPLETED | Leuprolide Acetate - Formulation A | 134 | |
| Overall Study | COMPLETED | Leuprolide Acetate - Formulation B | 114 | |
| Overall Study | NOT COMPLETED | Leuprolide Acetate - Formulation A | 17 | |
| Overall Study | NOT COMPLETED | Leuprolide Acetate - Formulation B | 45 |
Source ClinicalTrials.gov
Adverse events222
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Leuprolide Acetate - Formulation A | 6 | 151 | |
| other | Anemia | Blood and lymphatic system disorders | Leuprolide Acetate - Formulation B | 9 | 159 | |
| other | constipation | Gastrointestinal disorders | Leuprolide Acetate - Formulation A | 15 | 151 | |
| other | constipation | Gastrointestinal disorders | Leuprolide Acetate - Formulation B | 16 | 159 | |
| other | nausea | Gastrointestinal disorders | Leuprolide Acetate - Formulation A | 5 | 151 | |
| other | nausea | Gastrointestinal disorders | Leuprolide Acetate - Formulation B | 8 | 159 | |
| other | fatigue | General disorders | Leuprolide Acetate - Formulation A | 18 | 151 | |
| other | fatigue | General disorders | Leuprolide Acetate - Formulation B | 14 | 159 | |
| other | injection site pain | General disorders | Leuprolide Acetate - Formulation A | 27 | 151 | |
| other | injection site pain | General disorders | Leuprolide Acetate - Formulation B | 26 | 159 |
1 to 10 of 222Source ClinicalTrials.gov
See all 222 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Leuprolide Acetate - Formulation A | ||
| Total, all-cause mortality | Leuprolide Acetate - Formulation B | ||
| Total, other adverse events | Leuprolide Acetate - Formulation A | 133 | 151 |
| Total, other adverse events | Leuprolide Acetate - Formulation B | 127 | 159 |
| Total, serious adverse events | Leuprolide Acetate - Formulation A | 31 | 151 |
| Total, serious adverse events | Leuprolide Acetate - Formulation B | 41 | 159 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22025196 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Leuprolide Acetate - Formulation A vs Leuprolide Acetate - Formulation B: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00626431
GET https://conductscience.org/api/trials/v1/NCT00626431/results?page=2