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Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate (LMIS 25 mg) in Subjects With Prostate Cancer

NCT03261999 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2020-05-04

Study results available
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Summary

The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of subjects with prostate cancer, when administered as two injections twelve weeks apart.

Conditions

  • Prostatic Neoplasms

Interventions

DRUG

Leuprolide Mesylate

Subcutaneous injection of 25mg Leuprolide Mesylate

Sponsors & Collaborators

  • Foresee Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • John Mao, PhD · Foresee Pharmaceuticals Co., Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-26
Primary Completion
2018-11-19
Completion
2019-02-01
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Lithuania
  • Slovakia
  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03261999 on ClinicalTrials.gov