Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate in Subjects With Advanced Prostate Carcinoma
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|ClinicalTrials.gov Identifier: NCT02234115|
Recruitment Status : Completed
First Posted : September 9, 2014
Results First Posted : April 13, 2018
Last Update Posted : March 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Neoplasms||Drug: Leuprolide Mesylate||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||137 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Labeled, Singled-Arm Study of the Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate for Injectable Suspension (LMIS 50 mg) in Subjects With Advanced Prostate Carcinoma|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||August 30, 2016|
|Actual Study Completion Date :||January 5, 2017|
Experimental: Leuprolide Mesylate 50mg
All subjects will be males with advanced prostate carcinoma. They will be injected twice with a depot formulation containing 50 mg of Leuprolide Mesylate. The first dose on day 0 the second dose on day 168 (six months apart). Subjects will be followed until day 336.
Drug: Leuprolide Mesylate
Subcutaneous injection of 50mg Leuprolide Mesylate
- Efficacy of Leuprolide Mesylate (LMIS 50mg) [ Time Frame: 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).
- Number of Participants With Adverse Events (AEs) [ Time Frame: 336 days ]Safety analysis was based on the safety information from the laboratory evaluations, AEs, and SAEs.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02234115
|Study Director:||John Mao, PhD||Foresee Pharmaceuticals Co., Ltd.|