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Open-Label Safety Extension Study in Patients Who Have Previously Participated and Have Benefited From LMIS 50 mg

NCT02712320 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-03-26

Study results available
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Summary

This is a safety extension of up to 12 months of additional treatment with LMIS 50 mg after the subject has completed 12 months of treatment under Protocol FP01C-13-001 and remain eligible for continued treatment with androgen deprivation therapy. Subjects participating in Protocol FP01C-13-001-EX will be followed for safety only.

Conditions

  • Prostatic Neoplasms

Interventions

DRUG

LMIS 50 mg

Subcutaneous injection of 50 mg Leuprolide Mesylate

Sponsors & Collaborators

  • QPS-Qualitix

    collaborator INDUSTRY

  • Foresee Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • John Mao, Ph.D. · 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
2016-02-29
Primary Completion
2017-05-31
Completion
2017-12-19
FDA Drug
Yes

Countries

  • United States

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 NCT02712320 on ClinicalTrials.gov