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Study to Evaluate the Safety and Efficacy of Switching From Zoladex® Monthly or Quarterly, to Eligard® Semiannual.

NCT05304169 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2022-03-31

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy, quality of life and safety of switching from monthly (3.6 mg) or quarterly (10.8 mg) goserelin acetate (Zoladex®) to semiannual leuprorelin acetate 45 mg (Eligard® 45 mg) in prostate cancer patients with adequate hormonal castration level (plasma testosterone levels ≤50 ng/dL).

Conditions

Interventions

DRUG

Leuprorelin Acetate (Eligard® 45 mg).

Semiannually Leuprorelin Acetate (Eligard® 45 mg).

Sponsors & Collaborators

  • Zodiac Produtos Farmaceuticos S.A.

    lead INDUSTRY

Principal Investigators

  • Rafael Ferreira Coelho · ICESP - Instituto do Câncer do Estado de São Paulo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-14
Primary Completion
2018-06-15
Completion
2020-06-15

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

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 NCT05304169 on ClinicalTrials.gov