Trial · NCT02234115
Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate in Subjects With Advanced Prostate Carcinoma
NCT02234115, Phase 3, Completed, Foresee Pharmaceuticals Co., Ltd.; results first posted 2018-04-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate in Subjects With Advanced Prostate Carcinoma. Trials, record NCT02234115. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02234115
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate in Subjects With Advanced Prostate Carcinoma
- NCT number
- NCT02234115
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 137 participants, actual
- Lead sponsor
- Foresee Pharmaceuticals Co., Ltd.
- Conditions
- Prostatic Neoplasms
- Interventions
- Leuprolide Mesylate
- First posted
- 2014-09-09
- Last updated
- 2019-03-05
- Other registries' IDs
- eudract:2013-001790-25
- Results first posted
- 2018-04-13
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy of Leuprolide Mesylate (LMIS 50mg) | baseline to 28 days, 28 days to 336 days | The percentage of subjects with a serum testosterone concentration suppressed to castrate levels (≤ 50 ng/dL) following the first injection of LMIS 50 mg from Day 28 through Day 336 (remaining duration of the study). |
| Secondary | Number of Participants With Adverse Events (AEs) | 336 days | Safety analysis was based on the safety information from the laboratory evaluations, AEs, and SAEs. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy of Leuprolide Mesylate (LMIS 50mg) | baseline to 28 days, 28 days to 336 days | ITT | percentage of participants | MEAN |
| SECONDARY | Number of Participants With Adverse Events (AEs) | 336 days | Safety population | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Efficacy of Leuprolide Mesylate (LMIS 50mg) | Leuprolide Mesylate 50mg | 97.0 | 95% Confidence Interval 92.2 to 98.9 | percentage of participants | |
| Number of Participants With Adverse Events (AEs) | Leuprolide Mesylate 50mg | TEAE | 114 | Participants | |
| Number of Participants With Adverse Events (AEs) | Leuprolide Mesylate 50mg | Drug-related AEs | 85 | Participants | |
| Number of Participants With Adverse Events (AEs) | Leuprolide Mesylate 50mg | SAE | 20 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Leuprolide Mesylate 50mg | 137 | |
| Overall Study | ITT | Leuprolide Mesylate 50mg | 137 | |
| Overall Study | PP | Leuprolide Mesylate 50mg | 124 | |
| Overall Study | PK Subgroup | Leuprolide Mesylate 50mg | 31 | |
| Overall Study | COMPLETED | Leuprolide Mesylate 50mg | 122 | |
| Overall Study | NOT COMPLETED | Leuprolide Mesylate 50mg | 15 |
Source ClinicalTrials.gov
Adverse events38
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 | Fatigue | General disorders | Leuprolide Mesylate 50mg | 9 | 137 | 10 |
| other | Injection site pain | General disorders | Leuprolide Mesylate 50mg | 10 | 137 | 13 |
| other | Nasopharyngitis | Infections and infestations | Leuprolide Mesylate 50mg | 7 | 137 | 9 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Leuprolide Mesylate 50mg | 9 | 137 | 12 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Leuprolide Mesylate 50mg | 7 | 137 | 7 |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Leuprolide Mesylate 50mg | 13 | 137 | 18 |
| other | Nocturia | Renal and urinary disorders | Leuprolide Mesylate 50mg | 8 | 137 | 9 |
| other | Hot flush | Vascular disorders | Leuprolide Mesylate 50mg | 67 | 137 | 69 |
| other | Hypertension | Vascular disorders | Leuprolide Mesylate 50mg | 20 | 137 | 23 |
| serious | Angina pectoris | Cardiac disorders | Leuprolide Mesylate 50mg | 1 | 137 | 2 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Leuprolide Mesylate 50mg | 3 | 137 |
| Total, other adverse events | Leuprolide Mesylate 50mg | 114 | 137 |
| Total, serious adverse events | Leuprolide Mesylate 50mg | 20 | 137 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02234115
GET https://conductscience.org/api/trials/v1/NCT02234115/events?page=2