NCT02234115

Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate in Subjects With Advanced Prostate Carcinoma

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Foresee Pharmaceuticals Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of subjects with advanced prostate carcinoma, when administered as two injections six months apart.

Detailed description

This is a multi-center, open-label, single-arm study conducted in 2 parts. Part I was established to provide a vanguard of the first 30 subjects who will have more frequent monitoring of their safety. If safety is established, the remainder of the subjects will be entered into the clinical study (i.e., Part II). All subjects will be males with advanced prostate carcinoma judged to be candidates for medical androgen ablation therapy, and all will receive two injections of LMIS 50 mg six-month apart in an unblinded fashion.

Conditions

• Prostatic Neoplasms

Interventions

Type	Name	Description
DRUG	Leuprolide Mesylate	Subcutaneous injection of 50mg Leuprolide Mesylate

Timeline

• Start date: 2014-08-01
• Primary completion: 2016-08-30
• Completion: 2017-01-05
• First posted: 2014-09-09
• Last updated: 2019-03-05
• Results posted: 2018-04-13

Locations

29 sites across 8 countries: United States, Austria, Czechia, Germany, Lithuania, Poland, Slovakia, Taiwan