Trial Outcomes & Findings for Open-Label Safety Extension Study in Patients Who Have Previously Participated and Have Benefited From LMIS 50 mg (NCT NCT02712320)
NCT ID: NCT02712320
Last Updated: 2019-03-26
Results Overview
Evaluate the incidence of adverse events, drug-related adverse events, and serious adverse events
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
30 participants
Primary outcome timeframe
Up to 48 weeks
Results posted on
2019-03-26
Participant Flow
All subjects were males with advanced prostate carcinoma that completed 12 months (48-week) of therapy with Leuprolide Mesylate Injectable Suspension (LMIS) 50 mg under the Protocol FP01C-13-001 and were suitable candidates for continued medical androgen ablation therapy as judged by investigators.
Participant milestones
| Measure |
LMIS 50 mg
All subjects were males with advanced prostate carcinoma. They were injected 2 doses of LMIS 50 mg with approximately 6 months (24-week) apart (Month 12 and Month 18 from the initiation of Protocol FP01C-13-001)
LMIS 50 mg: Subcutaneous injection of 50 mg Leuprolide Mesylate
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
LMIS 50 mg
All subjects were males with advanced prostate carcinoma. They were injected 2 doses of LMIS 50 mg with approximately 6 months (24-week) apart (Month 12 and Month 18 from the initiation of Protocol FP01C-13-001)
LMIS 50 mg: Subcutaneous injection of 50 mg Leuprolide Mesylate
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Transferred to another facility
|
1
|
|
Overall Study
Treating with the prohibited medications
|
2
|
Baseline Characteristics
Open-Label Safety Extension Study in Patients Who Have Previously Participated and Have Benefited From LMIS 50 mg
Baseline characteristics by cohort
| Measure |
LMIS 50 mg
n=30 Participants
All subjects were males with advanced prostate carcinoma. They were injected 2 doses of LMIS 50 mg with approximately 6 months (24-week) apart (Month 12 and Month 18 from the initiation of Protocol FP01C-13-001)
LMIS 50 mg: Subcutaneous injection of 50 mg Leuprolide Mesylate
|
|---|---|
|
Age, Continuous
|
75.0 years
STANDARD_DEVIATION 7.86 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 48 weeksEvaluate the incidence of adverse events, drug-related adverse events, and serious adverse events
Outcome measures
| Measure |
LMIS 50 mg
n=30 Participants
All subjects were males with advanced prostate carcinoma. They were injected 2 doses of LMIS 50 mg with approximately 6 months (24-week) apart (Month 12 and Month 18 from the initiation of Protocol FP01C-13-001)
LMIS 50 mg: Subcutaneous injection of 50 mg Leuprolide Mesylate
|
|---|---|
|
Number of Participants With Adverse Events
TEAE
|
12 Participants
|
|
Number of Participants With Adverse Events
Drug-related AE
|
1 Participants
|
|
Number of Participants With Adverse Events
Serious Adverse Event (SAE)
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to 48 weeksPopulation: 8 subjects did not receive the second dose due to drug supply expiration, and 4 subjects due to early termination. Hence, only 18 subjects entered Day 168 (V4). 3 subjects were unable or unwilling to return on Day 336 (V6/EOS) due to early termination.
Use 12-lead resting electrocardiograms (ECGs) to evaluate the effect of LMIS 50 mg on cardiovascular function, such as heart rate, RR interval, QRS complex, PR interval, and QT interval.
Outcome measures
| Measure |
LMIS 50 mg
n=30 Participants
All subjects were males with advanced prostate carcinoma. They were injected 2 doses of LMIS 50 mg with approximately 6 months (24-week) apart (Month 12 and Month 18 from the initiation of Protocol FP01C-13-001)
LMIS 50 mg: Subcutaneous injection of 50 mg Leuprolide Mesylate
|
|---|---|
|
Evaluate the Effect of LMIS 50 mg on Cardiovascular Function
Overall Interpretation at Screening (V1) · Normal
|
4 Participants
|
|
Evaluate the Effect of LMIS 50 mg on Cardiovascular Function
Overall Interpretation at Screening (V1) · Abnormal-No clinical significance
|
25 Participants
|
|
Evaluate the Effect of LMIS 50 mg on Cardiovascular Function
Overall Interpretation on Day 168 (V4) · Normal
|
2 Participants
|
|
Evaluate the Effect of LMIS 50 mg on Cardiovascular Function
Overall Interpretation on Day 168 (V4) · Abnormal-No clinical significance
|
16 Participants
|
|
Evaluate the Effect of LMIS 50 mg on Cardiovascular Function
Overall Interpretation on Day 336 (V6/EOS) · Normal
|
7 Participants
|
|
Evaluate the Effect of LMIS 50 mg on Cardiovascular Function
Overall Interpretation on Day 336 (V6/EOS) · Abnormal-No clinical significance
|
20 Participants
|
PRIMARY outcome
Timeframe: 48 weeksPopulation: 8 subjects did not receive the second dose due to drug supply expiration, and 4 subjects due to early termination. Hence, only 18 subjects entered Day 168 (V4). 3 subjects were unable or unwilling to return on Day 336 (V6/EOS) due to early termination.
Hematology assessments performed in this study included hemoglobin, hematocrit, Red Blood Cell (RBC), White Blood Cell (WBC), platelets, neutrophil, eosinophil, basophil, lymphocyte, monocyte, and HbA1c.
Outcome measures
| Measure |
LMIS 50 mg
n=30 Participants
All subjects were males with advanced prostate carcinoma. They were injected 2 doses of LMIS 50 mg with approximately 6 months (24-week) apart (Month 12 and Month 18 from the initiation of Protocol FP01C-13-001)
LMIS 50 mg: Subcutaneous injection of 50 mg Leuprolide Mesylate
|
|---|---|
|
Laboratory Assessments - Hematology
Hemoglobin (gm/dL) at Screening (V1) · Normal
|
17 Participants
|
|
Laboratory Assessments - Hematology
Hemoglobin (gm/dL) at Screening (V1) · Abnormal-No clinical significance
|
13 Participants
|
|
Laboratory Assessments - Hematology
Hemoglobin (gm/dL) at Screening (V1) · Abnormal-Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Hematology
Hemoglobin (gm/dL) on Day 168 (V4) · Normal
|
9 Participants
|
|
Laboratory Assessments - Hematology
Hemoglobin (gm/dL) on Day 168 (V4) · Abnormal-No clinical significance
|
9 Participants
|
|
Laboratory Assessments - Hematology
Hemoglobin (gm/dL) on Day 168 (V4) · Abnormal-Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Hematology
Hemoglobin (gm/dL) on Day 336 (V6/EOS) · Normal
|
13 Participants
|
|
Laboratory Assessments - Hematology
Hemoglobin (gm/dL) on Day 336 (V6/EOS) · Abnormal-No clinical significance
|
14 Participants
|
|
Laboratory Assessments - Hematology
Hemoglobin (gm/dL) on Day 336 (V6/EOS) · Abnormal-Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Hematology
Hematocrit (%) at Screening (V1) · Normal
|
18 Participants
|
|
Laboratory Assessments - Hematology
Hematocrit (%) at Screening (V1) · Abnormal-No clinical significance
|
12 Participants
|
|
Laboratory Assessments - Hematology
Hematocrit (%) at Screening (V1) · Abnormal-Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Hematology
Hematocrit (%) on Day 168 (V4) · Normal
|
4 Participants
|
|
Laboratory Assessments - Hematology
Hematocrit (%) on Day 168 (V4) · Abnormal-No clinical significance
|
14 Participants
|
|
Laboratory Assessments - Hematology
Hematocrit (%) on Day 168 (V4) · Abnormal-Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Hematology
Hematocrit (%) on Day 336 (V6/EOS) · Normal
|
7 Participants
|
|
Laboratory Assessments - Hematology
Hematocrit (%) on Day 336 (V6/EOS) · Abnormal-No clinical significance
|
20 Participants
|
|
Laboratory Assessments - Hematology
Hematocrit (%) on Day 336 (V6/EOS) · Abnormal-Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Hematology
RBC (x10.e6/uL) at Screening (V1) · Normal
|
15 Participants
|
|
Laboratory Assessments - Hematology
RBC (x10.e6/uL) at Screening (V1) · Abnormal-No clinical significance
|
15 Participants
|
|
Laboratory Assessments - Hematology
RBC (x10.e6/uL) at Screening (V1) · Abnormal-Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Hematology
RBC (x10.e6/uL) on Day 168 (V4) · Normal
|
2 Participants
|
|
Laboratory Assessments - Hematology
RBC (x10.e6/uL) on Day 168 (V4) · Abnormal-No clinical significance
|
16 Participants
|
|
Laboratory Assessments - Hematology
RBC (x10.e6/uL) on Day 168 (V4) · Abnormal-Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Hematology
RBC (x10.e6/uL) on Day 336 (V6/EOS) · Normal
|
6 Participants
|
|
Laboratory Assessments - Hematology
RBC (x10.e6/uL) on Day 336 (V6/EOS) · Abnormal-No clinical significance
|
21 Participants
|
|
Laboratory Assessments - Hematology
RBC (x10.e6/uL) on Day 336 (V6/EOS) · Abnormal-Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Hematology
WBC (x10.e3/uL) at Screening (V1) · Normal
|
26 Participants
|
|
Laboratory Assessments - Hematology
WBC (x10.e3/uL) at Screening (V1) · Abnormal-No clinical significance
|
4 Participants
|
|
Laboratory Assessments - Hematology
WBC (x10.e3/uL) at Screening (V1) · Abnormal-Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Hematology
WBC (x10.e3/uL) on Day 168 (V4) · Normal
|
18 Participants
|
|
Laboratory Assessments - Hematology
WBC (x10.e3/uL) on Day 168 (V4) · Abnormal-No clinical significance
|
0 Participants
|
|
Laboratory Assessments - Hematology
WBC (x10.e3/uL) on Day 168 (V4) · Abnormal-Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Hematology
WBC (x10.e3/uL) on Day 336 (V6/EOS) · Normal
|
22 Participants
|
|
Laboratory Assessments - Hematology
WBC (x10.e3/uL) on Day 336 (V6/EOS) · Abnormal-No clinical significance
|
5 Participants
|
|
Laboratory Assessments - Hematology
WBC (x10.e3/uL) on Day 336 (V6/EOS) · Abnormal-Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Hematology
Platelets (x10.e3/uL) at Screening (V1) · Normal
|
27 Participants
|
|
Laboratory Assessments - Hematology
Platelets (x10.e3/uL) at Screening (V1) · Abnormal-No clinical significance
|
3 Participants
|
|
Laboratory Assessments - Hematology
Platelets (x10.e3/uL) at Screening (V1) · Abnormal-Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Hematology
Platelets (x10.e3/uL) on Day 168 (V4) · Normal
|
14 Participants
|
|
Laboratory Assessments - Hematology
Platelets (x10.e3/uL) on Day 168 (V4) · Abnormal-No clinical significance
|
4 Participants
|
|
Laboratory Assessments - Hematology
Platelets (x10.e3/uL) on Day 168 (V4) · Abnormal-Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Hematology
Platelets (x10.e3/uL) on Day 336 (V6/EOS) · Normal
|
23 Participants
|
|
Laboratory Assessments - Hematology
Platelets (x10.e3/uL) on Day 336 (V6/EOS) · Abnormal-No clinical significance
|
4 Participants
|
|
Laboratory Assessments - Hematology
Platelets (x10.e3/uL) on Day 336 (V6/EOS) · Abnormal-Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Hematology
Neutrophils(%) at Screening (V1) · Normal
|
28 Participants
|
|
Laboratory Assessments - Hematology
Neutrophils(%) at Screening (V1) · Abnormal-No clinical significance
|
2 Participants
|
|
Laboratory Assessments - Hematology
Neutrophils(%) at Screening (V1) · Abnormal-Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Hematology
Neutrophils(%) on Day 168 (V4) · Normal
|
15 Participants
|
|
Laboratory Assessments - Hematology
Neutrophils(%) on Day 168 (V4) · Abnormal-No clinical significance
|
2 Participants
|
|
Laboratory Assessments - Hematology
Neutrophils(%) on Day 168 (V4) · Abnormal-Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Hematology
Neutrophils(%) on Day 336 (V6/EOS) · Normal
|
22 Participants
|
|
Laboratory Assessments - Hematology
Neutrophils(%) on Day 336 (V6/EOS) · Abnormal-No clinical significance
|
4 Participants
|
|
Laboratory Assessments - Hematology
Neutrophils(%) on Day 336 (V6/EOS) · Abnormal-Clinical significance
|
1 Participants
|
|
Laboratory Assessments - Hematology
Eosinophils(%) at Screening (V1) · Normal
|
25 Participants
|
|
Laboratory Assessments - Hematology
Eosinophils(%) at Screening (V1) · Abnormal-No clinical significance
|
5 Participants
|
|
Laboratory Assessments - Hematology
Eosinophils(%) at Screening (V1) · Abnormal-Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Hematology
Eosinophils(%) on Day 168 (V4) · Normal
|
15 Participants
|
|
Laboratory Assessments - Hematology
Eosinophils(%) on Day 168 (V4) · Abnormal-No clinical significance
|
2 Participants
|
|
Laboratory Assessments - Hematology
Eosinophils(%) on Day 168 (V4) · Abnormal-Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Hematology
Eosinophils(%) on Day 336 (V6/EOS) · Normal
|
20 Participants
|
|
Laboratory Assessments - Hematology
Eosinophils(%) on Day 336 (V6/EOS) · Abnormal-No clinical significance
|
7 Participants
|
|
Laboratory Assessments - Hematology
Eosinophils(%) on Day 336 (V6/EOS) · Abnormal-Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Hematology
Basophils (%) at Screening (V1) · Normal
|
30 Participants
|
|
Laboratory Assessments - Hematology
Basophils (%) at Screening (V1) · Abnormal-No clinical significance
|
0 Participants
|
|
Laboratory Assessments - Hematology
Basophils (%) at Screening (V1) · Abnormal-Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Hematology
Basophils (%) on Day 168 (V4) · Normal
|
16 Participants
|
|
Laboratory Assessments - Hematology
Basophils (%) on Day 168 (V4) · Abnormal-No clinical significance
|
1 Participants
|
|
Laboratory Assessments - Hematology
Basophils (%) on Day 168 (V4) · Abnormal-Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Hematology
Basophils (%) on Day 336 (V6/EOS) · Normal
|
27 Participants
|
|
Laboratory Assessments - Hematology
Basophils (%) on Day 336 (V6/EOS) · Abnormal-No clinical significance
|
0 Participants
|
|
Laboratory Assessments - Hematology
Basophils (%) on Day 336 (V6/EOS) · Abnormal-Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Hematology
Lymphocytes (%) at Screening (V1) · Normal
|
28 Participants
|
|
Laboratory Assessments - Hematology
Lymphocytes (%) at Screening (V1) · Abnormal-No clinical significance
|
2 Participants
|
|
Laboratory Assessments - Hematology
Lymphocytes (%) at Screening (V1) · Abnormal-Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Hematology
Lymphocytes (%) on Day 168 (V4) · Normal
|
14 Participants
|
|
Laboratory Assessments - Hematology
Lymphocytes (%) on Day 168 (V4) · Abnormal-No clinical significance
|
3 Participants
|
|
Laboratory Assessments - Hematology
Lymphocytes (%) on Day 168 (V4) · Abnormal-Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Hematology
Lymphocytes (%) on Day 336 (V6/EOS) · Normal
|
21 Participants
|
|
Laboratory Assessments - Hematology
Lymphocytes (%) on Day 336 (V6/EOS) · Abnormal-No clinical significance
|
6 Participants
|
|
Laboratory Assessments - Hematology
Lymphocytes (%) on Day 336 (V6/EOS) · Abnormal-Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Hematology
Monocytes (%) at Screening (V1) · Normal
|
26 Participants
|
|
Laboratory Assessments - Hematology
Monocytes (%) at Screening (V1) · Abnormal-No clinical significance
|
4 Participants
|
|
Laboratory Assessments - Hematology
Monocytes (%) at Screening (V1) · Abnormal-Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Hematology
Monocytes (%) on Day 168 (V4) · Normal
|
15 Participants
|
|
Laboratory Assessments - Hematology
Monocytes (%) on Day 168 (V4) · Abnormal-No clinical significance
|
2 Participants
|
|
Laboratory Assessments - Hematology
Monocytes (%) on Day 168 (V4) · Abnormal-Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Hematology
Monocytes (%) on Day 336 (V6/EOS) · Normal
|
24 Participants
|
|
Laboratory Assessments - Hematology
Monocytes (%) on Day 336 (V6/EOS) · Abnormal-No clinical significance
|
3 Participants
|
|
Laboratory Assessments - Hematology
Monocytes (%) on Day 336 (V6/EOS) · Abnormal-Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Hematology
HgbA1c (%) at Screening (V1) · Normal
|
22 Participants
|
|
Laboratory Assessments - Hematology
HgbA1c (%) at Screening (V1) · Abnormal-No clinical significance
|
8 Participants
|
|
Laboratory Assessments - Hematology
HgbA1c (%) at Screening (V1) · Abnormal-Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Hematology
HgbA1c (%) on Day 336 (V6/EOS) · Normal
|
14 Participants
|
|
Laboratory Assessments - Hematology
HgbA1c (%) on Day 336 (V6/EOS) · Abnormal-No clinical significance
|
10 Participants
|
|
Laboratory Assessments - Hematology
HgbA1c (%) on Day 336 (V6/EOS) · Abnormal-Clinical significance
|
0 Participants
|
PRIMARY outcome
Timeframe: 48 weeksPopulation: 8 subjects did not receive the second dose due to drug supply expiration, and 4 subjects due to early termination. Hence, only 18 subjects entered Day 168 (V4). 3 subjects were unable or unwilling to return on Day 336 (V6/EOS) due to early termination.
Biochemical assessments performed in this study included Alanine Aminotransferase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP), total bilirubin, Blood Urea Nitrogen (BUN), serum Cr, potassium, sodium, magnesium, calcium, phosphorus, blood glucose, Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and triglycerides.
Outcome measures
| Measure |
LMIS 50 mg
n=30 Participants
All subjects were males with advanced prostate carcinoma. They were injected 2 doses of LMIS 50 mg with approximately 6 months (24-week) apart (Month 12 and Month 18 from the initiation of Protocol FP01C-13-001)
LMIS 50 mg: Subcutaneous injection of 50 mg Leuprolide Mesylate
|
|---|---|
|
Laboratory Assessments - Biochemistry
BUN (mg/dL) on Day 336 (V6/EOS) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
Serum Cr. (mg/dL) at Screening (V1) · Normal
|
27 Participants
|
|
Laboratory Assessments - Biochemistry
Serum Cr. (mg/dL) at Screening (V1) · Abnormal - No clinical significance
|
3 Participants
|
|
Laboratory Assessments - Biochemistry
Serum Cr. (mg/dL) at Screening (V1) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
Serum Cr. (mg/dL) on Day 168 (V4) · Normal
|
15 Participants
|
|
Laboratory Assessments - Biochemistry
Serum Cr. (mg/dL) on Day 168 (V4) · Abnormal - No clinical significance
|
3 Participants
|
|
Laboratory Assessments - Biochemistry
Serum Cr. (mg/dL) on Day 168 (V4) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
Serum Cr. (mg/dL) on Day 336 (V6/EOS) · Normal
|
24 Participants
|
|
Laboratory Assessments - Biochemistry
Serum Cr. (mg/dL) on Day 336 (V6/EOS) · Abnormal - No clinical significance
|
3 Participants
|
|
Laboratory Assessments - Biochemistry
Serum Cr. (mg/dL) on Day 336 (V6/EOS) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
Potassium (mEq/L) at Screening (V1) · Normal
|
28 Participants
|
|
Laboratory Assessments - Biochemistry
Potassium (mEq/L) at Screening (V1) · Abnormal - No clinical significance
|
2 Participants
|
|
Laboratory Assessments - Biochemistry
Potassium (mEq/L) at Screening (V1) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
Potassium (mEq/L) on Day 168 (V4) · Normal
|
18 Participants
|
|
Laboratory Assessments - Biochemistry
Potassium (mEq/L) on Day 168 (V4) · Abnormal - No clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
Potassium (mEq/L) on Day 168 (V4) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
Potassium (mEq/L) on Day 336 (V6/EOS) · Normal
|
26 Participants
|
|
Laboratory Assessments - Biochemistry
Potassium (mEq/L) on Day 336 (V6/EOS) · Abnormal - No clinical significance
|
1 Participants
|
|
Laboratory Assessments - Biochemistry
Potassium (mEq/L) on Day 336 (V6/EOS) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
Sodium (mEq/L) at Screening (V1) · Normal
|
30 Participants
|
|
Laboratory Assessments - Biochemistry
Sodium (mEq/L) at Screening (V1) · Abnormal - No clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
Sodium (mEq/L) at Screening (V1) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
Sodium (mEq/L) on Day 168 (V4) · Normal
|
17 Participants
|
|
Laboratory Assessments - Biochemistry
Sodium (mEq/L) on Day 168 (V4) · Abnormal - No clinical significance
|
1 Participants
|
|
Laboratory Assessments - Biochemistry
Sodium (mEq/L) on Day 168 (V4) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
Sodium (mEq/L) on Day 336 (V6/EOS) · Normal
|
26 Participants
|
|
Laboratory Assessments - Biochemistry
Sodium (mEq/L) on Day 336 (V6/EOS) · Abnormal - No clinical significance
|
1 Participants
|
|
Laboratory Assessments - Biochemistry
Sodium (mEq/L) on Day 336 (V6/EOS) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
Magnesium (mg/dL) at Screening (V1) · Normal
|
26 Participants
|
|
Laboratory Assessments - Biochemistry
Magnesium (mg/dL) at Screening (V1) · Abnormal - No clinical significance
|
4 Participants
|
|
Laboratory Assessments - Biochemistry
Magnesium (mg/dL) at Screening (V1) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
Magnesium (mg/dL) on Day 168 (V4) · Normal
|
14 Participants
|
|
Laboratory Assessments - Biochemistry
Magnesium (mg/dL) on Day 168 (V4) · Abnormal - No clinical significance
|
4 Participants
|
|
Laboratory Assessments - Biochemistry
Magnesium (mg/dL) on Day 168 (V4) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
Magnesium (mg/dL) on Day 336 (V6/EOS) · Normal
|
23 Participants
|
|
Laboratory Assessments - Biochemistry
Magnesium (mg/dL) on Day 336 (V6/EOS) · Abnormal - No clinical significance
|
4 Participants
|
|
Laboratory Assessments - Biochemistry
Magnesium (mg/dL) on Day 336 (V6/EOS) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
Calcium (mg/dL) at Screening (V1) · Normal
|
29 Participants
|
|
Laboratory Assessments - Biochemistry
Calcium (mg/dL) at Screening (V1) · Abnormal - No clinical significance
|
1 Participants
|
|
Laboratory Assessments - Biochemistry
Calcium (mg/dL) at Screening (V1) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
Calcium (mg/dL) on Day 168 (V4) · Normal
|
17 Participants
|
|
Laboratory Assessments - Biochemistry
Calcium (mg/dL) on Day 168 (V4) · Abnormal - No clinical significance
|
1 Participants
|
|
Laboratory Assessments - Biochemistry
Calcium (mg/dL) on Day 168 (V4) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
Calcium (mg/dL) on Day 336 (V6/EOS) · Normal
|
25 Participants
|
|
Laboratory Assessments - Biochemistry
Calcium (mg/dL) on Day 336 (V6/EOS) · Abnormal - No clinical significance
|
2 Participants
|
|
Laboratory Assessments - Biochemistry
Calcium (mg/dL) on Day 336 (V6/EOS) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
Phosphorus (mg/dL) at Screening (V1) · Normal
|
29 Participants
|
|
Laboratory Assessments - Biochemistry
Phosphorus (mg/dL) at Screening (V1) · Abnormal - No clinical significance
|
1 Participants
|
|
Laboratory Assessments - Biochemistry
Phosphorus (mg/dL) at Screening (V1) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
Phosphorus (mg/dL) on Day 168 (V4) · Normal
|
16 Participants
|
|
Laboratory Assessments - Biochemistry
Phosphorus (mg/dL) on Day 168 (V4) · Abnormal - No clinical significance
|
2 Participants
|
|
Laboratory Assessments - Biochemistry
Phosphorus (mg/dL) on Day 168 (V4) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
Phosphorus (mg/dL) on Day 336 (V6/EOS) · Normal
|
25 Participants
|
|
Laboratory Assessments - Biochemistry
Phosphorus (mg/dL) on Day 336 (V6/EOS) · Abnormal - No clinical significance
|
2 Participants
|
|
Laboratory Assessments - Biochemistry
Phosphorus (mg/dL) on Day 336 (V6/EOS) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
Blood glucose (mg/dL) at Screening (V1) · Normal
|
22 Participants
|
|
Laboratory Assessments - Biochemistry
Blood glucose (mg/dL) at Screening (V1) · Abnormal - No clinical significance
|
8 Participants
|
|
Laboratory Assessments - Biochemistry
Blood glucose (mg/dL) at Screening (V1) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
Blood glucose (mg/dL) on Day 168 (V4) · Normal
|
13 Participants
|
|
Laboratory Assessments - Biochemistry
Blood glucose (mg/dL) on Day 168 (V4) · Abnormal - No clinical significance
|
5 Participants
|
|
Laboratory Assessments - Biochemistry
Blood glucose (mg/dL) on Day 168 (V4) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
Blood glucose (mg/dL) on Day 336 (V6/EOS) · Normal
|
14 Participants
|
|
Laboratory Assessments - Biochemistry
Blood glucose (mg/dL) on Day 336 (V6/EOS) · Abnormal - No clinical significance
|
12 Participants
|
|
Laboratory Assessments - Biochemistry
Blood glucose (mg/dL) on Day 336 (V6/EOS) · Abnormal - Clinical significance
|
1 Participants
|
|
Laboratory Assessments - Biochemistry
LDL (mg/dL) at Screening (V1) · Normal
|
28 Participants
|
|
Laboratory Assessments - Biochemistry
LDL (mg/dL) at Screening (V1) · Abnormal - No clinical significance
|
1 Participants
|
|
Laboratory Assessments - Biochemistry
LDL (mg/dL) at Screening (V1) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
LDL (mg/dL) on Day 168 (V4) · Normal
|
13 Participants
|
|
Laboratory Assessments - Biochemistry
LDL (mg/dL) on Day 168 (V4) · Abnormal - No clinical significance
|
5 Participants
|
|
Laboratory Assessments - Biochemistry
LDL (mg/dL) on Day 168 (V4) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
LDL (mg/dL) on Day 336 (V6/EOS) · Normal
|
19 Participants
|
|
Laboratory Assessments - Biochemistry
LDL (mg/dL) on Day 336 (V6/EOS) · Abnormal - No clinical significance
|
7 Participants
|
|
Laboratory Assessments - Biochemistry
LDL (mg/dL) on Day 336 (V6/EOS) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
HDL (mg/dL) at Screening (V1) · Normal
|
21 Participants
|
|
Laboratory Assessments - Biochemistry
HDL (mg/dL) at Screening (V1) · Abnormal - No clinical significance
|
9 Participants
|
|
Laboratory Assessments - Biochemistry
HDL (mg/dL) at Screening (V1) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
HDL (mg/dL) on Day 168 (V4) · Normal
|
12 Participants
|
|
Laboratory Assessments - Biochemistry
HDL (mg/dL) on Day 168 (V4) · Abnormal - No clinical significance
|
6 Participants
|
|
Laboratory Assessments - Biochemistry
HDL (mg/dL) on Day 168 (V4) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
HDL (mg/dL) on Day 336 (V6/EOS) · Normal
|
21 Participants
|
|
Laboratory Assessments - Biochemistry
HDL (mg/dL) on Day 336 (V6/EOS) · Abnormal - No clinical significance
|
6 Participants
|
|
Laboratory Assessments - Biochemistry
HDL (mg/dL) on Day 336 (V6/EOS) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
Triglycerides(mg/dL) at Screening (V1) · Normal
|
17 Participants
|
|
Laboratory Assessments - Biochemistry
Triglycerides(mg/dL) at Screening (V1) · Abnormal - No clinical significance
|
13 Participants
|
|
Laboratory Assessments - Biochemistry
Triglycerides(mg/dL) at Screening (V1) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
Triglycerides(mg/dL) on Day 168 (V4) · Normal
|
6 Participants
|
|
Laboratory Assessments - Biochemistry
Triglycerides(mg/dL) on Day 168 (V4) · Abnormal - No clinical significance
|
12 Participants
|
|
Laboratory Assessments - Biochemistry
Triglycerides(mg/dL) on Day 168 (V4) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
Triglycerides(mg/dL) on Day 336 (V6/EOS) · Normal
|
13 Participants
|
|
Laboratory Assessments - Biochemistry
Triglycerides(mg/dL) on Day 336 (V6/EOS) · Abnormal - No clinical significance
|
14 Participants
|
|
Laboratory Assessments - Biochemistry
Triglycerides(mg/dL) on Day 336 (V6/EOS) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
ALT (U/L) at Screening (V1) · Normal
|
28 Participants
|
|
Laboratory Assessments - Biochemistry
ALT (U/L) at Screening (V1) · Abnormal - No clinical significance
|
2 Participants
|
|
Laboratory Assessments - Biochemistry
ALT (U/L) at Screening (V1) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
ALT (U/L) on Day 168 (V4) · Normal
|
17 Participants
|
|
Laboratory Assessments - Biochemistry
ALT (U/L) on Day 168 (V4) · Abnormal - No clinical significance
|
1 Participants
|
|
Laboratory Assessments - Biochemistry
ALT (U/L) on Day 168 (V4) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
ALT (U/L) on Day 336 (V6/EOS) · Normal
|
26 Participants
|
|
Laboratory Assessments - Biochemistry
ALT (U/L) on Day 336 (V6/EOS) · Abnormal - No clinical significance
|
1 Participants
|
|
Laboratory Assessments - Biochemistry
ALT (U/L) on Day 336 (V6/EOS) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
AST (U/L) at Screening (V1) · Normal
|
29 Participants
|
|
Laboratory Assessments - Biochemistry
AST (U/L) at Screening (V1) · Abnormal - No clinical significance
|
1 Participants
|
|
Laboratory Assessments - Biochemistry
AST (U/L) at Screening (V1) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
AST (U/L) on Day 168 (V4) · Normal
|
16 Participants
|
|
Laboratory Assessments - Biochemistry
AST (U/L) on Day 168 (V4) · Abnormal - No clinical significance
|
2 Participants
|
|
Laboratory Assessments - Biochemistry
AST (U/L) on Day 168 (V4) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
AST (U/L) on Day 336 (V6/EOS) · Normal
|
25 Participants
|
|
Laboratory Assessments - Biochemistry
AST (U/L) on Day 336 (V6/EOS) · Abnormal - No clinical significance
|
2 Participants
|
|
Laboratory Assessments - Biochemistry
AST (U/L) on Day 336 (V6/EOS) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
ALP (U/L) at Screening (V1) · Normal
|
26 Participants
|
|
Laboratory Assessments - Biochemistry
ALP (U/L) at Screening (V1) · Abnormal - No clinical significance
|
3 Participants
|
|
Laboratory Assessments - Biochemistry
ALP (U/L) at Screening (V1) · Abnormal - Clinical significance
|
1 Participants
|
|
Laboratory Assessments - Biochemistry
ALP (U/L) on Day 168 (V4) · Normal
|
10 Participants
|
|
Laboratory Assessments - Biochemistry
ALP (U/L) on Day 168 (V4) · Abnormal - No clinical significance
|
8 Participants
|
|
Laboratory Assessments - Biochemistry
ALP (U/L) on Day 168 (V4) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
ALP (U/L) on Day 336 (V6/EOS) · Normal
|
17 Participants
|
|
Laboratory Assessments - Biochemistry
ALP (U/L) on Day 336 (V6/EOS) · Abnormal - No clinical significance
|
10 Participants
|
|
Laboratory Assessments - Biochemistry
ALP (U/L) on Day 336 (V6/EOS) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
Total bilirubin(mg/dL) at Screening (V1) · Normal
|
30 Participants
|
|
Laboratory Assessments - Biochemistry
Total bilirubin(mg/dL) at Screening (V1) · Abnormal - No clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
Total bilirubin(mg/dL) at Screening (V1) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
Total bilirubin(mg/dL) on Day 168 (V4) · Normal
|
18 Participants
|
|
Laboratory Assessments - Biochemistry
Total bilirubin(mg/dL) on Day 168 (V4) · Abnormal - No clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
Total bilirubin(mg/dL) on Day 168 (V4) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
Total bilirubin(mg/dL) on Day 336 (V6/EOS) · Normal
|
27 Participants
|
|
Laboratory Assessments - Biochemistry
Total bilirubin(mg/dL) on Day 336 (V6/EOS) · Abnormal - No clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
Total bilirubin(mg/dL) on Day 336 (V6/EOS) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
BUN (mg/dL) at Screening (V1) · Normal
|
21 Participants
|
|
Laboratory Assessments - Biochemistry
BUN (mg/dL) at Screening (V1) · Abnormal - No clinical significance
|
9 Participants
|
|
Laboratory Assessments - Biochemistry
BUN (mg/dL) at Screening (V1) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
BUN (mg/dL) on Day 168 (V4) · Normal
|
9 Participants
|
|
Laboratory Assessments - Biochemistry
BUN (mg/dL) on Day 168 (V4) · Abnormal - No clinical significance
|
9 Participants
|
|
Laboratory Assessments - Biochemistry
BUN (mg/dL) on Day 168 (V4) · Abnormal - Clinical significance
|
0 Participants
|
|
Laboratory Assessments - Biochemistry
BUN (mg/dL) on Day 336 (V6/EOS) · Normal
|
15 Participants
|
|
Laboratory Assessments - Biochemistry
BUN (mg/dL) on Day 336 (V6/EOS) · Abnormal - No clinical significance
|
12 Participants
|
PRIMARY outcome
Timeframe: 48 weeksPopulation: 8 subjects did not receive the second dose due to drug supply expiration, and 4 subjects due to early termination. Hence, only 18 subjects entered Day 168 (V4). 3 subjects were unable or unwilling to return on Day 336 (V6/EOS) due to early termination.
Urinalysis was performed to assess the safety profile of LMIS 50 mg during the study period, including pH, specific gravity, and the presences of leukocytes, erythrocytes, or protein.
Outcome measures
| Measure |
LMIS 50 mg
n=30 Participants
All subjects were males with advanced prostate carcinoma. They were injected 2 doses of LMIS 50 mg with approximately 6 months (24-week) apart (Month 12 and Month 18 from the initiation of Protocol FP01C-13-001)
LMIS 50 mg: Subcutaneous injection of 50 mg Leuprolide Mesylate
|
|---|---|
|
Laboratory Assessments - Urinalysis
pH at Screening (V1) · Normal
|
30 Participants
|
|
Laboratory Assessments - Urinalysis
pH at Screening (V1) · Abnormal - No clinical significance
|
0 Participants
|
|
Laboratory Assessments - Urinalysis
pH on Day 168 (V4) · Normal
|
18 Participants
|
|
Laboratory Assessments - Urinalysis
pH on Day 168 (V4) · Abnormal - No clinical significance
|
0 Participants
|
|
Laboratory Assessments - Urinalysis
pH on Day 336 (V6/EOS) · Normal
|
27 Participants
|
|
Laboratory Assessments - Urinalysis
pH on Day 336 (V6/EOS) · Abnormal - No clinical significance
|
0 Participants
|
|
Laboratory Assessments - Urinalysis
Specific gravity at Screening (V1) · Normal
|
30 Participants
|
|
Laboratory Assessments - Urinalysis
Specific gravity at Screening (V1) · Abnormal - No clinical significance
|
0 Participants
|
|
Laboratory Assessments - Urinalysis
Specific gravity on Day 168 (V4) · Normal
|
18 Participants
|
|
Laboratory Assessments - Urinalysis
Specific gravity on Day 168 (V4) · Abnormal - No clinical significance
|
0 Participants
|
|
Laboratory Assessments - Urinalysis
Specific gravity on Day 336 (V6/EOS) · Normal
|
26 Participants
|
|
Laboratory Assessments - Urinalysis
Specific gravity on Day 336 (V6/EOS) · Abnormal - No clinical significance
|
1 Participants
|
|
Laboratory Assessments - Urinalysis
Leukocyte at Screening (V1) · Normal
|
27 Participants
|
|
Laboratory Assessments - Urinalysis
Leukocyte at Screening (V1) · Abnormal - No clinical significance
|
3 Participants
|
|
Laboratory Assessments - Urinalysis
Leukocyte on Day 168 (V4) · Normal
|
16 Participants
|
|
Laboratory Assessments - Urinalysis
Leukocyte on Day 168 (V4) · Abnormal - No clinical significance
|
2 Participants
|
|
Laboratory Assessments - Urinalysis
Leukocyte on Day 336 (V6/EOS) · Normal
|
23 Participants
|
|
Laboratory Assessments - Urinalysis
Leukocyte on Day 336 (V6/EOS) · Abnormal - No clinical significance
|
4 Participants
|
|
Laboratory Assessments - Urinalysis
Erythrocyte at Screening (V1) · Normal
|
28 Participants
|
|
Laboratory Assessments - Urinalysis
Erythrocyte at Screening (V1) · Abnormal - No clinical significance
|
2 Participants
|
|
Laboratory Assessments - Urinalysis
Erythrocyte on Day 168 (V4) · Normal
|
17 Participants
|
|
Laboratory Assessments - Urinalysis
Erythrocyte on Day 168 (V4) · Abnormal - No clinical significance
|
1 Participants
|
|
Laboratory Assessments - Urinalysis
Erythrocyte on Day 336 (V6/EOS) · Normal
|
25 Participants
|
|
Laboratory Assessments - Urinalysis
Erythrocyte on Day 336 (V6/EOS) · Abnormal - No clinical significance
|
2 Participants
|
|
Laboratory Assessments - Urinalysis
Protein at Screening (V1) · Normal
|
24 Participants
|
|
Laboratory Assessments - Urinalysis
Protein at Screening (V1) · Abnormal - No clinical significance
|
6 Participants
|
|
Laboratory Assessments - Urinalysis
Protein on Day 168 (V4) · Normal
|
17 Participants
|
|
Laboratory Assessments - Urinalysis
Protein on Day 168 (V4) · Abnormal - No clinical significance
|
1 Participants
|
|
Laboratory Assessments - Urinalysis
Protein on Day 336 (V6/EOS) · Normal
|
23 Participants
|
|
Laboratory Assessments - Urinalysis
Protein on Day 336 (V6/EOS) · Abnormal - No clinical significance
|
4 Participants
|
Adverse Events
LMIS 50 mg
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LMIS 50 mg
n=30 participants at risk
All subjects were males with advanced prostate carcinoma. They were injected 2 doses of LMIS 50 mg with approximately 6 months (24-week) apart (Month 12 and Month 18 from the initiation of Protocol FP01C-13-001)
LMIS 50 mg: Subcutaneous injection of 50 mg Leuprolide Mesylate
|
|---|---|
|
General disorders
Perforated ulcer
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
|
Infections and infestations
Pyelonephritis acute
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
|
Infections and infestations
Sepsis
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
|
Injury, poisoning and procedural complications
Hip fracture
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
|
Surgical and medical procedures
Knee arthroplasty
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
|
Vascular disorders
Deep vein thrombosis
|
3.3%
1/30 • Number of events 1 • 48 weeks
|
Other adverse events
| Measure |
LMIS 50 mg
n=30 participants at risk
All subjects were males with advanced prostate carcinoma. They were injected 2 doses of LMIS 50 mg with approximately 6 months (24-week) apart (Month 12 and Month 18 from the initiation of Protocol FP01C-13-001)
LMIS 50 mg: Subcutaneous injection of 50 mg Leuprolide Mesylate
|
|---|---|
|
General disorders
Fatigue
|
6.7%
2/30 • Number of events 2 • 48 weeks
|
|
Vascular disorders
Hypertension
|
6.7%
2/30 • Number of events 2 • 48 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All information from the trial is property of the Sponsor and the PI has no right on it except the prior writing authorization of the sponsor.
- Publication restrictions are in place
Restriction type: OTHER