A clinical trial for advanced prostatic cancer patients . The study medication will be Leuprolide Mesylate, which will be administered as an injection twice. Both the study doctors and clinical trial participants know which treatment is being administered, there will be only one treatment group. The safety and efficacy of the medicinal product will be tested during the study.

Registry ID

EUCTR2013-001790-25

Source registry

EUCTR

Status

Completed

Phase

PHASE3

Sponsor

Foresee Pharmaceuticals Co., Ltd.

Start date

2014-08-25

Completion date

2016-09-02

Last update

2026-08-16

Conditions

• Advanced Prostate Carcinoma

Summary

Primary objectives: 1. Determine the safety and tolerability of LMIS 50 mg for up to 1 year of exposure following 2 subcutaneous doses given at 6 months apart in subjects with advanced prostate carcinoma; 2. Establish the efficacy of LMIS 50 mg for up to 1 year following 2 subcutaneous doses given at 6 months apart in subjects with advanced prostate carcinoma, as determined by the magnitude and duration of suppression of serum testosterone levels; and 3. Evaluate the pharmacokinetic behavior of serum leuprolide following 2 subcutaneous injections of LMIS 50 mg given 6 months apart.

Locations

• , , Germany
• , , Slovakia
• , , Czechia
• , , Poland
• , , Austria
• , , Lithuania

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