Effectiveness, pharmacokinetics, and safety of a new sustained-release leuprolide acetate 3.75-mg depot formulation for testosterone suppression in patients with prostate cancer: a Phase III, open-label, international multicenter study.

Marberger M, Kaisary AV, Shore ND, Karlin GS, Savulsky C, Mis R, Leuratti C, Germa JR

Clinical therapeutics1 Apr 2010Cited by 29 (Europe PMC)

PMID20435244DOI10.1016/j.clinthera.2010.04.013PepBankPUB-20435244

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study16

16 results from studies that gave the peptide. 16 results from people.

01HumanNon-randomized trialEfficacy outcome
In prostate cancer patients, leuprolide acetate depot achieved sustained testosterone suppression in 96.8% (152/157; 95% CI, 92.7%-99.0%).
In plain wordsIn prostate cancer patients, leuprolide acetate depot achieved sustained testosterone suppression in 96.8% (152/157).
Peptide
Leuprolide
Outcome
DecreasePrimary testosterone suppression success
Study
n = 157
Analysis
Primary
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
3.75 mg monthly · intramuscular · 168 daysAs given in this study (human).
Measurements
Proportion of successful patients
96.8%
152/157 evaluable patients
95% CI of success proportion
92.7 to 99%
95% CI
Source sentences
Summary
The proportion of successful patients over the total number of evaluable patients was 96.8% (152/157; 95% CI,92.7%-99.0%).
3 context sentences(design, population, supporting numbers)
Summary · context
Treatment success was defined as testosterone suppression below the clinical castration level (ie, <or=0.5 ng/mL) at day 28 and maintenance of clinical castration until study completion (day 168).
Summary · context
This was a Phase III, open-label, international multicenter clinical trial.
Summary · context
Patients with prostate cancer who, in the judgment of the investigators, could benefit from androgen deprivation therapy received 6 monthly intramuscular injections of leuprolide acetate 3.75-mg depot.
Report a problemFND-2043524401
02HumanNon-randomized trialSafety outcome
In prostate cancer patients receiving leuprolide acetate depot, treatment-related hot flashes occurred in 45.0% (72/160).
In plain wordsIn prostate cancer patients receiving leuprolide acetate depot, treatment-related hot flashes occurred in 45.0% (72/160).
Peptide
Leuprolide
Outcome
Not applicableHot flashes
Study
n = 160
Outcome group
Adverse events · Endocrine and hormones
Studied dose
3.75 mg monthly · intramuscular · 168 daysAs given in this study (human).
Measurements
Treatment-related hot flashes
45%
72/160 patients
Source sentences
Summary
The most common treatment-related adverse event was hot flashes (45.0% [72/160]).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a Phase III, open-label, international multicenter clinical trial.
Summary · context
Patients with prostate cancer who, in the judgment of the investigators, could benefit from androgen deprivation therapy received 6 monthly intramuscular injections of leuprolide acetate 3.75-mg depot.
Report a problemFND-2043524412
03HumanNon-randomized trialSafety outcome
In prostate cancer patients receiving leuprolide acetate depot, fatigue occurred in <or=6.3% (10/160).
In plain wordsIn prostate cancer patients receiving leuprolide acetate depot, fatigue occurred in <or=6.3% (10/160).
Peptide
Leuprolide
Outcome
Not applicableFatigue
Study
n = 160
Outcome group
Adverse events · Whole body
Studied dose
3.75 mg monthly · intramuscular · 168 daysAs given in this study (human).
Measurements
Fatigue incidence
≤ 6.3%
at most 10/160 patients
Source sentences
Summary
Fatigue, hyperhidrosis, night sweats, and headache each occurred in <or=6.3% (10/160) of the patients.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a Phase III, open-label, international multicenter clinical trial.
Summary · context
Patients with prostate cancer who, in the judgment of the investigators, could benefit from androgen deprivation therapy received 6 monthly intramuscular injections of leuprolide acetate 3.75-mg depot.
Report a problemFND-2043524413
04HumanNon-randomized trialSafety outcome
In prostate cancer patients receiving leuprolide acetate depot, hyperhidrosis occurred in <or=6.3% (10/160).
In plain wordsIn prostate cancer patients receiving leuprolide acetate depot, excessive sweating occurred in <or=6.3% (10/160).
Peptide
Leuprolide
Outcome
Not applicableHyperhidrosis
Study
n = 160
Outcome group
Adverse events · Endocrine and hormones
Studied dose
3.75 mg monthly · intramuscular · 168 daysAs given in this study (human).
Measurements
Hyperhidrosis incidence
≤ 6.3%
at most 10/160 patients
Source sentences
Summary
Fatigue, hyperhidrosis, night sweats, and headache each occurred in <or=6.3% (10/160) of the patients.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a Phase III, open-label, international multicenter clinical trial.
Summary · context
Patients with prostate cancer who, in the judgment of the investigators, could benefit from androgen deprivation therapy received 6 monthly intramuscular injections of leuprolide acetate 3.75-mg depot.
Report a problemFND-2043524414
05HumanNon-randomized trialSafety outcome
In prostate cancer patients receiving leuprolide acetate depot, night sweats occurred in <or=6.3% (10/160).
In plain wordsIn prostate cancer patients receiving leuprolide acetate depot, night sweats occurred in <or=6.3% (10/160).
Peptide
Leuprolide
Outcome
Not applicableNight sweats
Study
n = 160
Outcome group
Adverse events · Endocrine and hormones
Studied dose
3.75 mg monthly · intramuscular · 168 daysAs given in this study (human).
Measurements
Night sweats incidence
≤ 6.3%
at most 10/160 patients
Source sentences
Summary
Fatigue, hyperhidrosis, night sweats, and headache each occurred in <or=6.3% (10/160) of the patients.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a Phase III, open-label, international multicenter clinical trial.
Summary · context
Patients with prostate cancer who, in the judgment of the investigators, could benefit from androgen deprivation therapy received 6 monthly intramuscular injections of leuprolide acetate 3.75-mg depot.
Report a problemFND-2043524415
06HumanNon-randomized trialSafety outcome
In prostate cancer patients receiving leuprolide acetate depot, headache occurred in <or=6.3% (10/160).
In plain wordsIn prostate cancer patients receiving leuprolide acetate depot, headache occurred in <or=6.3% (10/160).
Peptide
Leuprolide
Outcome
Not applicableHeadache
Study
n = 160
Outcome group
Adverse events · Nervous system and cognition
Studied dose
3.75 mg monthly · intramuscular · 168 daysAs given in this study (human).
Measurements
Headache incidence
≤ 6.3%
at most 10/160 patients
Source sentences
Summary
Fatigue, hyperhidrosis, night sweats, and headache each occurred in <or=6.3% (10/160) of the patients.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a Phase III, open-label, international multicenter clinical trial.
Summary · context
Patients with prostate cancer who, in the judgment of the investigators, could benefit from androgen deprivation therapy received 6 monthly intramuscular injections of leuprolide acetate 3.75-mg depot.
Report a problemFND-2043524416
07HumanNon-randomized trialSafety outcome
In prostate cancer patients receiving leuprolide acetate depot, injection-site pain occurred in 8.1% (13/160).
In plain wordsIn prostate cancer patients receiving leuprolide acetate depot, injection-site pain occurred in 8.1% (13/160).
Peptide
Leuprolide
Outcome
Not applicableInjection-site pain
Study
n = 160
Outcome group
Adverse events · Whole body
Studied dose
3.75 mg monthly · intramuscular · 168 daysAs given in this study (human).
Measurements
Injection-site pain incidence
8.1%
13/160 patients
Source sentences
Summary
The most frequently reported local adverse reaction was pain at the injection site, experienced by 8.1% (13/160) of the patients.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a Phase III, open-label, international multicenter clinical trial.
Summary · context
Patients with prostate cancer who, in the judgment of the investigators, could benefit from androgen deprivation therapy received 6 monthly intramuscular injections of leuprolide acetate 3.75-mg depot.
Report a problemFND-2043524417
08HumanNon-randomized trialEfficacy outcome
In prostate cancer patients, 96.8% (151/156) achieved castrate testosterone levels by day 28 with leuprolide acetate depot.
In plain wordsIn prostate cancer patients, 96.8% (151/156) reached castrate testosterone levels by day 28 with leuprolide acetate depot.
Peptide
Leuprolide
Outcome
DecreaseCastrate testosterone by day 28
Study
n = 156
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
3.75 mg monthly · intramuscular · Result by day 28; regimen was 6 monthly injectionsAs given in this study (human).
Measurements
Evaluable patients at castrate levels by day 28
96.8%
151/156 evaluable patients
Source sentences
Summary
By day 28, 96.8% (151/156) of the evaluable patients had achieved castrate levels, and 73.1% (114/156) achieved testosterone concentrations <0.2 ng/mL.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a Phase III, open-label, international multicenter clinical trial.
Summary · context
Patients with prostate cancer who, in the judgment of the investigators, could benefit from androgen deprivation therapy received 6 monthly intramuscular injections of leuprolide acetate 3.75-mg depot.
Report a problemFND-2043524404
09HumanNon-randomized trialEfficacy outcome
In prostate cancer patients, 73.1% (114/156) achieved testosterone <0.2 ng/mL by day 28 with leuprolide acetate depot.
In plain wordsIn prostate cancer patients, 73.1% (114/156) reached testosterone <0.2 ng/mL by day 28 with leuprolide acetate depot.
Peptide
Leuprolide
Outcome
DecreaseTestosterone below 0.2 ng/mL by day 28
Study
n = 156
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
3.75 mg monthly · intramuscular · Result by day 28; regimen was 6 monthly injectionsAs given in this study (human).
Measurements
Evaluable patients with testosterone <0.2 ng/mL by day 28
73.1%
114/156 evaluable patients
Source sentences
Summary
By day 28, 96.8% (151/156) of the evaluable patients had achieved castrate levels, and 73.1% (114/156) achieved testosterone concentrations <0.2 ng/mL.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a Phase III, open-label, international multicenter clinical trial.
Summary · context
Patients with prostate cancer who, in the judgment of the investigators, could benefit from androgen deprivation therapy received 6 monthly intramuscular injections of leuprolide acetate 3.75-mg depot.
Report a problemFND-2043524405
10HumanNon-randomized trialEfficacy outcome
In prostate cancer patients, 78.7% (122/155) achieved testosterone suppression by day 21 with leuprolide acetate depot.
In plain wordsIn prostate cancer patients, 78.7% (122/155) achieved testosterone suppression by day 21 with leuprolide acetate depot.
Peptide
Leuprolide
Outcome
DecreaseTestosterone suppression by day 21
Study
n = 155
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
3.75 mg monthly · intramuscular · Result by day 21; regimen was 6 monthly injectionsAs given in this study (human).
Measurements
Evaluable patients with testosterone suppression by day 21
78.7%
122/155 evaluable patients
Source sentences
Summary
Of the evaluable patients, 78.7% (122/155) achieved testosterone suppression by day 21.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a Phase III, open-label, international multicenter clinical trial.
Summary · context
Patients with prostate cancer who, in the judgment of the investigators, could benefit from androgen deprivation therapy received 6 monthly intramuscular injections of leuprolide acetate 3.75-mg depot.
Report a problemFND-2043524403
11HumanNon-randomized trialEfficacy outcome
In prostate cancer patients completing leuprolide acetate depot treatment, 100% (152/152) maintained castrate testosterone at study end.
In plain wordsIn prostate cancer patients completing leuprolide acetate depot treatment, 100% (152/152) maintained castrate testosterone at study end.
Peptide
Leuprolide
Outcome
DecreaseMaintained castrate testosterone at study end
Study
n = 152
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
3.75 mg monthly · intramuscular · 168 daysAs given in this study (human).
Measurements
Completers maintaining castrate levels at study end
100%
152/152 completers
Source sentences
Summary
At study end, 100% (152/152) of the patients completing the study maintained castrate levels, and 92.8% (141/152) had testosterone concentrations <or=0.2 ng/mL.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a Phase III, open-label, international multicenter clinical trial.
Summary · context
Patients with prostate cancer who, in the judgment of the investigators, could benefit from androgen deprivation therapy received 6 monthly intramuscular injections of leuprolide acetate 3.75-mg depot.
Report a problemFND-2043524406
12HumanNon-randomized trialEfficacy outcome
In prostate cancer patients completing leuprolide acetate depot treatment, 92.8% (141/152) had testosterone <or=0.2 ng/mL at study end.
In plain wordsIn prostate cancer patients completing leuprolide acetate depot treatment, 92.8% (141/152) had testosterone <or=0.2 ng/mL at study end.
Peptide
Leuprolide
Outcome
DecreaseTestosterone at most 0.2 ng/mL at study end
Study
n = 152
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
3.75 mg monthly · intramuscular · 168 daysAs given in this study (human).
Measurements
Completers with testosterone <=0.2 ng/mL at study end
92.8%
141/152 completers
Source sentences
Summary
At study end, 100% (152/152) of the patients completing the study maintained castrate levels, and 92.8% (141/152) had testosterone concentrations <or=0.2 ng/mL.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a Phase III, open-label, international multicenter clinical trial.
Summary · context
Patients with prostate cancer who, in the judgment of the investigators, could benefit from androgen deprivation therapy received 6 monthly intramuscular injections of leuprolide acetate 3.75-mg depot.
Report a problemFND-2043524407
13HumanNon-randomized trialPharmacokinetics
In prostate cancer patients, leuprolide acetate depot pharmacokinetics showed sustained release during the first 3 months.
In plain wordsIn prostate cancer patients, leuprolide acetate depot measurements showed sustained drug release during the first 3 months.
Peptide
Leuprolide
Outcome
Not applicableSustained release pharmacokinetics
Study
n = 12
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
3.75 mg monthly · intramuscular · First 3 months of treatmentAs given in this study (human).
Source sentences
Summary
The pharmacokinetic profile of leuprolide during the first 3 months of treatment, evaluated in a subset of the study population (n = 12), showed sustained release of leuprolide from the formulation.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a Phase III, open-label, international multicenter clinical trial.
Summary · context
Patients with prostate cancer who, in the judgment of the investigators, could benefit from androgen deprivation therapy received 6 monthly intramuscular injections of leuprolide acetate 3.75-mg depot.
Report a problemFND-2043524408
14HumanNon-randomized trialPharmacokinetics
In prostate cancer patients, leuprolide acetate depot AUC from day 0 to day 28 was 25,976.5 (7892.0) pg/mL per day.
In plain wordsIn prostate cancer patients, leuprolide acetate depot exposure from day 0 to day 28 was 25,976.5 pg/mL per day.
Peptide
Leuprolide
Outcome
Not applicableAUC from day 0 to 28
Study
n = 12
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
3.75 mg monthly · intramuscular · Day 0 to day 28As given in this study (human).
Measurements
AUC(0-t), day 0 to 28
25976.5 pg/mL per day
subset n = 12
AUC(0-t) value in parentheses, day 0 to 28
7892 pg/mL per day
subset n = 12; abstract does not label it
Source sentences
Summary
Values for AUC(0-t) calculated from day 0 to day 28, days 28 to 56, and days 56 to 84 were 25,976.5 (7892.0), 30,685.5 (9348.4), and 31,030.9 (10,745.0) pg/mL per day, respectively.
3 context sentences(design, population, supporting numbers)
Summary · context
The pharmacokinetic profile of leuprolide during the first 3 months of treatment, evaluated in a subset of the study population (n = 12), showed sustained release of leuprolide from the formulation.
Summary · context
This was a Phase III, open-label, international multicenter clinical trial.
Summary · context
Patients with prostate cancer who, in the judgment of the investigators, could benefit from androgen deprivation therapy received 6 monthly intramuscular injections of leuprolide acetate 3.75-mg depot.
Report a problemFND-2043524409
15HumanNon-randomized trialPharmacokinetics
In prostate cancer patients, leuprolide acetate depot AUC from days 28 to 56 was 30,685.5 (9348.4) pg/mL per day.
In plain wordsIn prostate cancer patients, leuprolide acetate depot exposure from days 28 to 56 was 30,685.5 pg/mL per day.
Peptide
Leuprolide
Outcome
Not applicableAUC from day 28 to 56
Study
n = 12
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
3.75 mg monthly · intramuscular · Day 28 to day 56As given in this study (human).
Measurements
AUC(0-t), day 28 to 56
30685.5 pg/mL per day
subset n = 12
AUC(0-t) value in parentheses, day 28 to 56
9348.4 pg/mL per day
subset n = 12; abstract does not label it
Source sentences
Summary
Values for AUC(0-t) calculated from day 0 to day 28, days 28 to 56, and days 56 to 84 were 25,976.5 (7892.0), 30,685.5 (9348.4), and 31,030.9 (10,745.0) pg/mL per day, respectively.
3 context sentences(design, population, supporting numbers)
Summary · context
The pharmacokinetic profile of leuprolide during the first 3 months of treatment, evaluated in a subset of the study population (n = 12), showed sustained release of leuprolide from the formulation.
Summary · context
This was a Phase III, open-label, international multicenter clinical trial.
Summary · context
Patients with prostate cancer who, in the judgment of the investigators, could benefit from androgen deprivation therapy received 6 monthly intramuscular injections of leuprolide acetate 3.75-mg depot.
Report a problemFND-2043524410
16HumanNon-randomized trialPharmacokinetics
In prostate cancer patients, leuprolide acetate depot AUC from days 56 to 84 was 31,030.9 (10,745.0) pg/mL per day.
In plain wordsIn prostate cancer patients, leuprolide acetate depot exposure from days 56 to 84 was 31,030.9 pg/mL per day.
Peptide
Leuprolide
Outcome
Not applicableAUC from day 56 to 84
Study
n = 12
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
3.75 mg monthly · intramuscular · Day 56 to day 84As given in this study (human).
Measurements
AUC(0-t), day 56 to 84
31030.9 pg/mL per day
subset n = 12
AUC(0-t) value in parentheses, day 56 to 84
10,745 pg/mL per day
subset n = 12; abstract does not label it
Source sentences
Summary
Values for AUC(0-t) calculated from day 0 to day 28, days 28 to 56, and days 56 to 84 were 25,976.5 (7892.0), 30,685.5 (9348.4), and 31,030.9 (10,745.0) pg/mL per day, respectively.
3 context sentences(design, population, supporting numbers)
Summary · context
The pharmacokinetic profile of leuprolide during the first 3 months of treatment, evaluated in a subset of the study population (n = 12), showed sustained release of leuprolide from the formulation.
Summary · context
This was a Phase III, open-label, international multicenter clinical trial.
Summary · context
Patients with prostate cancer who, in the judgment of the investigators, could benefit from androgen deprivation therapy received 6 monthly intramuscular injections of leuprolide acetate 3.75-mg depot.
Report a problemFND-2043524411

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3NCT00128531

Leuprolide Acetate 3.75 mg Depot to Treat Prostate Cancer

GP-Pharmn = 120Sept 2005 to Nov 2007

Prostate Cancer

Trial page ClinicalTrials.govUpdated 14 Nov 2007

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:37 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

Publication types

MeSH terms

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